<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04502433</url>
  </required_header>
  <id_info>
    <org_study_id>CLI-050000-04</org_study_id>
    <secondary_id>2020-002632-75</secondary_id>
    <nct_id>NCT04502433</nct_id>
  </id_info>
  <brief_title>Poractant Alfa (Curosurf®)) -- Effect in Adult Patients Diagnosed With 2019 Novel Coronavirus (SARS-COV-19; (Covid-19)) Acute Respiratory Distress Syndrome (ARDS)</brief_title>
  <official_title>Multicenter, Open-label, Randomised Trial to Assess the Efficacy and Tolerability of Poractant Alfa(Porcine Surfactant, Curosurf®) in Hospitalized Patients With SARS-COV-19 Acute Respiratory Distress Syndrome (ARDS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chiesi Farmaceutici S.p.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chiesi Farmaceutici S.p.A.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate the efficacy and safety of poractant alfa&#xD;
      (Curosurf®), administered by endotracheal (ET) instillation in hospitalized adult patients&#xD;
      diagnosed with SARS-COV-19 acute respiratory distress syndrome (ARDS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a multicentre, open-label, randomized phase II proof-of-concept study.&#xD;
&#xD;
      The efficacy and safety of poractant alfa was evaluated in terms of ventilatory free days&#xD;
      during the 21 days after randomization, in adult patients diagnosed with ARDS due to&#xD;
      SARS-COV-19 infection.&#xD;
&#xD;
      Each patient randomized to the study treatment received 3 administrations of Curosurf ® with&#xD;
      a 24 hours dosing interval. The assessment collection was up to Day 28, when the evaluation&#xD;
      occurred at the Intensive Care Unit (ICU), or by phone call if the patient has already been&#xD;
      discharged.&#xD;
&#xD;
      Seventy patients were planned to be randomized in the study with a ratio 3:2 (i.e. 42&#xD;
      patients in the poractant alfa arm and 28 in the control arm). The control arm population&#xD;
      received Standard of Care (SoC). This study was conducted in United Kingdom (UK), United&#xD;
      States of America (US), and Italy.&#xD;
&#xD;
      Overall, 13 patients (Curosurf ® group) and 8 patients (control group) were randomised in the&#xD;
      study. Due to low recruitment rate the study was terminated early for non-safety reasons.&#xD;
&#xD;
      Curosurf® is a pulmonary surfactant of natural origin which, when delivered endotracheally&#xD;
      (ET). Curosurf® is currently approved for marketing as treatment of premature neonates with&#xD;
      RDS or at risk of Respiratory Distress Syndrome (RDS). Chiesi Farmaceutici S.p.A (Chiesi)&#xD;
      conducted this study with its porcine-derived surfactant, Curosurf® (poractant alfa), to&#xD;
      evaluate the efficacy and safety in ventilated adult patients who were critically unwell in&#xD;
      intensive care with SARS-COV-19 ARDS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The enrolment was extended. Nevertheless, despite the Sponsor's attempts, the infection status&#xD;
    did not permit the identification of eligible patients for the study to complete it in a&#xD;
    reasonable time.&#xD;
  </why_stopped>
  <start_date type="Actual">January 6, 2021</start_date>
  <completion_date type="Actual">March 17, 2022</completion_date>
  <primary_completion_date type="Actual">March 17, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Seventy patients will be randomized in the study with a ratio 3:2 (i.e. 42 patients in the poractant alfa arm and 28 in the control arm).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Days Alive and Ventilator-free Days</measure>
    <time_frame>up to 21 days</time_frame>
    <description>The number of days alive and ventilator-free days, defined as the number of days the patient is not receiving mechanical ventilation over the 21 days following randomisation.&#xD;
Mechanical ventilation was defined as invasive and non-invasive. The patient was defined as free of mechanical ventilation after 12 hours from the suspension of either invasive and non-invasive ventilation. Patients who died or were mechanically ventilated longer than this period were assessed as zero ventilator-free days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients Alive and Free of Respiratory Failure at Day 28</measure>
    <time_frame>at Day 28</time_frame>
    <description>The percentage of patients alive and free of respiratory failure (i.e. without need for mechanical ventilation, extracorporeal membrane oxygenation (ECMO), non-invasive ventilation, or high-flow nasal cannula oxygen delivery) at Day 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days Alive and Ventilator-Free at Day 28</measure>
    <time_frame>at Day 28</time_frame>
    <description>The number of days alive and ventilator-free (i.e. free of any mechanical ventilation for at least 12 hours) at Day 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality at Day 21 and Day 28</measure>
    <time_frame>at Day 21 and at Day 28</time_frame>
    <description>Mortality at Day 21 and Day 28 of the study by treatment group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days Alive and Free From Invasive Ventilation at Day 21 and Day 28</measure>
    <time_frame>Day 21 and Day 28</time_frame>
    <description>The number of days alive and free from invasive ventilation at Day 21 and Day 28 is presented by treatment group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days Alive and Free From Non-Invasive Ventilation at Day 21 and Day 28</measure>
    <time_frame>Day 21 and Day 28</time_frame>
    <description>The number of days alive and free from non-invasive ventilation at Day 21 and Day 28 is presented by treatment group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Improvement in Severity Status at Day 28 or Discharge (Severity Score: Mild, Moderate, Severe, or Death)</measure>
    <time_frame>Day 28 or Discharge, whichever comes first</time_frame>
    <description>The severity status of patients at baseline and at Day 28/Discharge and the percentage of patients with improvement in severity status (i.e. a decrease of at least 1 point in severity status) at Day 28/Discharge relative to baseline is presented.&#xD;
Severity was assessed using a point score system: Severity score was defined as mild, moderate, severe (see below*), or death and was based on PaO2/FiO2 ratio and patient status at Day 28/Discharge and numerically rated from 1-4, respectively. An improvement in severity was defined as a decrease of at least 1 point between baseline and Day 28/Discharge.&#xD;
At Day 28 the last follow up evaluation took place on the ICU if, still requiring critical care, or by phone call if the patient has been discharged from ICU by that time.&#xD;
*Mild: 200 mmHg &lt; PaO2/FiO2 ratio ≤300 mmHg; Moderate: 100 mmHg &lt; PaO2/FiO2 ratio ≤200 mmHg; Severe: PaO2/FiO2 ratio ≤100 mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Arterial Partial Pressure of Oxygen / Fraction of Inspired Oxygen (PaO2/FiO2) Ratio at Each Timepoint</measure>
    <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28</time_frame>
    <description>Change from baseline in PaO2/FiO2 ratio measured at each timepoint following administration of each dose in the treatment and control group.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Partial pressure of oxygen (PaO2) is the oxygen pressure in arterial blood. The fraction of inspired oxygen (FiO2) is the concentration of oxygen in the gas mixture.&#xD;
The fraction of inspired oxygen (PaO2/FiO2) ratio is widely used in ICUs as an indicator of oxygenation status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients Alive and With PaO2/FiO2 Ratio Improvement &gt;20% Compared to Baseline at Each Timepoint</measure>
    <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28</time_frame>
    <description>The percentages of patients in categories of PaO2/FiO2 ratio improvement compared to baseline (&gt;20%) at all timepoints post-baseline are summarised by treatment group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fraction of Inspired Oxygen (FiO2) at Each Timepoint</measure>
    <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28</time_frame>
    <description>The FiO2 at baseline and at selected timepoints post-baseline was measured. Results are shown as changes from baseline, summarised by treatment group.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline. The unit for the variable is percent (%) and what is reported is an absolute change.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of ICU Stay (Days) at Day 28</measure>
    <time_frame>up to 28 days</time_frame>
    <description>The length of ICU stay (days) at Day 28 is presented by treatment by treatment group. Patients who died or were mechanically ventilated longer than this period were assigned with 28 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients Alive and Out of Intensive Care Unit (ICU) at Day 28</measure>
    <time_frame>Day 28</time_frame>
    <description>The percentage of patients alive and out of ICU at Day 28 is presented by treatment group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delta Sequential Organ Failure Assessment (SOFA) Score and Sub-component Measure at Day 3 and Day 28</measure>
    <time_frame>Day 3 and Day 28 or discharge -- whichever comes first</time_frame>
    <description>The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body. The SOFA score was used to determine the extent of organ failure at Day 3 and Day 28/Discharge with respect to a pre-randomisation assessment.&#xD;
The total score was derived from six sub-scores system categories: respiratory, neurological, cardiovascular, hepatic, coagulation, and renal systems; respective sub-scores were calculated primarily considering PaO2/FiO2 ratio, Glasgow Coma Scale, mean arterial pressure (MAP) or requirement for vasopressor administration, bilirubin levels, platelet levels and creatinine levels or daily urine output.&#xD;
A score of 0, 1, 2, 3, or 4) was assigned to each of the six system category. The total score ranged from 0 (min) to 24 (max) points. To be considered organ failure free, a patient had to have a score of 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients Alive and Free of Organ Failure (SOFA Score=0)</measure>
    <time_frame>at day 28 or discharge -- whichever comes first</time_frame>
    <description>The percentage of patients alive and organ failure free (defined as SOFA score=0) at Day 28/Discharge is presented by treatment group.&#xD;
The total score was derived from six sub-scores system categories: respiratory, neurological, cardiovascular, hepatic, coagulation, and renal systems; respective sub-scores were calculated primarily considering PaO2/FiO2 ratio, Glasgow Coma Scale, mean arterial pressure (MAP) or requirement for vasopressor administration, bilirubin levels, platelet levels and creatinine levels or daily urine output.&#xD;
A score of 0, 1, 2, 3, or 4) was assigned to each of the six system category. The total score ranged from 0 (min) to 24 (max) points. To be considered organ failure free, a patient had to have a score of 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilatory Parameter: Tidal Volume -- Change From Baseline in Tidal Volume (mL/kg BW) at All Timepoints up to Day 3 (72 Hours) and at Day 28</measure>
    <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28</time_frame>
    <description>Ventilatory parameter: Change from baseline in tidal volume (mL/kg BW) at all timepoints up to Day 3 (72 hours) and at Day 28.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Tidal volume is the amount of air that moves in or out of the lungs with each respiratory cycle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilatory Parameter: Respiratory Rate -- Change From Baseline in Respiratory Rate (Breaths/Minute) at All Timepoints up to Day 3 (72 Hours) and at Day 28</measure>
    <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28</time_frame>
    <description>Ventilatory parameter: Change from baseline in respiratory rate (breaths/minute) at all timepoints up to Day 3 (72 hours) and at Day 28.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Respiratory rate is the number of breaths taken per minute.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilatory Parameter: Dynamic Compliance -- Change From Baseline in Dynamic Compliance (mL/cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28</measure>
    <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28</time_frame>
    <description>Ventilatory parameter: Change from baseline in dynamic compliance (mL/cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Dynamic compliance: is the continuous measurement of pulmonary compliance calculated at each point representing schematic changes during rhythmic breathing. Dynamic compliance monitors both elastic and airway resistance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilatory Parameter: Static Compliance -- Change From Baseline in Static Compliance (mL/cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28</measure>
    <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28</time_frame>
    <description>Ventilatory parameter: static compliance -- change from baseline in static compliance (mL/cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
At each time point the number of patients that contributed with a result value is indicated for both study arms.&#xD;
Static Compliance: represents pulmonary compliance at a given fixed volume when there is no airflow, and muscles are relaxed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilatory Parameter: Positive End-Expiratory Pressure (PEEP) -- Change From Baseline in PEEP (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28</measure>
    <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28</time_frame>
    <description>Ventilatory parameter: Positive End-Expiratory Pressure -- Change from baseline in PEEP (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
At each time point the number of patients that contributed with a result value is indicated for both study arms.&#xD;
Positive end-expiratory pressure (PEEP) is the positive pressure that will remain in the airways at the end of the respiratory cycle (end of exhalation) that is greater than the atmospheric pressure in mechanically ventilated patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilatory Parameter: Peak Inspiratory Pressure -- Change From Baseline in Peak Inspiratory Pressure (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28</measure>
    <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28</time_frame>
    <description>Ventilatory parameter: Peak Inspiratory Pressure -- Change from baseline in peak inspiratory pressure (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
At each time point the number of patients that contributed with a result value is indicated for both study arms.&#xD;
Peak inspiratory pressure (PIP) is the highest level of pressure applied to the lungs during inhalation. In mechanical ventilation the number reflects a positive pressure in centimetres of water pressure (cmH2O).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilatory Parameter: Plateau Pressure -- Change From Baseline in Plateau Pressure (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28</measure>
    <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28</time_frame>
    <description>Ventilatory parameter: Plateau Pressure -- Change from baseline in plateau pressure (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
At each time point the number of patients that contributed with a result value is indicated for both study arms.&#xD;
Plateau pressure is the pressure that is applied by the mechanical ventilator to the small airways and alveoli.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Gas Analysis Acid-base Balance Parameters: Change From Baseline in Blood Gas Analysis Acid-base Balance Parameters -- pH</measure>
    <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28</time_frame>
    <description>Change from baseline in blood gas analysis acid-base balance parameters -- pH.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Arterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Partial Pressure of Carbon Dioxide (pCO2)</measure>
    <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28</time_frame>
    <description>Change from baseline in blood gas analysis acid-base balance parameter -- pCO2.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Arterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Partial Pressure of Oxygen (pO2)</measure>
    <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28</time_frame>
    <description>Change from baseline in blood gas analysis acid-base balance parameter -- pO2.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Arterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Bicarbonate (HCO3)</measure>
    <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28</time_frame>
    <description>Change from baseline in blood gas analysis acid-base balance parameter -- Bicarbonate (HCO3).&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Measured at 6-12-24h after each poractant alfa administration up to 72 hours and at similar timepoints in the control group (6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation) and then every 24 hours till the patient is discharged from the ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Blood Parameter -- Lactate</measure>
    <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28</time_frame>
    <description>Change from baseline in blood parameter -- Lactate&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
At each time point the number of patients that contributed with a result value is indicated for both study arms.&#xD;
Arterial blood lactate was measured at 6, 12, 24, 30, 36, 48, 54, 60, and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality -- TEAEs Leading to Death</measure>
    <time_frame>up to day 28</time_frame>
    <description>The incidence of treatment-emergent adverse event (TEAEs) leading to death is presented by treatment group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients treated with standard-of-care (SoC), as control cohort</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Poractant alfa</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CUROSURF® (poractant alfa)</intervention_name>
    <description>Three administrations with a 24 hours dosing interval.&#xD;
Each endotracheal (ET) administration 1, 2, and 3 consisted of poractant alfa bolus:&#xD;
30mg /kg (Lean Body Weight-LBW) = 0.375ml /kg LBW, diluted with normal saline up to 2ml /kg LBW.</description>
    <arm_group_label>Poractant alfa</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants were eligible to be included in the study if the following criteria apply:&#xD;
&#xD;
          1. Male or female ≥18 and ≤ 80 years of age&#xD;
&#xD;
          2. Informed consent for participation in the study (refer to section 15 for detailed&#xD;
             inform consent procedure)&#xD;
&#xD;
          3. Positive 2019-nCoV Reverse Transcription Polymerase Chain Reaction (rt-PCR) before&#xD;
             randomisation&#xD;
&#xD;
          4. Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen (PaO2/FiO2) ratio &lt;&#xD;
             150 mmHg&#xD;
&#xD;
          5. Lung compliance ≤45 ml/cmH20&#xD;
&#xD;
          6. Intubated and artificially ventilated less than 48 hours before the first poractant&#xD;
             alfa administration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants were excluded from the study if any of the following criteria apply:&#xD;
&#xD;
          1. Any contraindications to surfactant administration e.g., pulmonary hemorrhage and&#xD;
             pneumothorax)&#xD;
&#xD;
          2. Weight &lt; 40kg&#xD;
&#xD;
          3. Stage 4 severe chronic kidney disease (i.e., Estimated Glomerular Filtration Rate&#xD;
             (eGFR) &lt; 30)&#xD;
&#xD;
          4. Pregnancy&#xD;
&#xD;
          5. Administration of any nebulized surfactant in the 48 hours before the first poractant&#xD;
             alfa administration&#xD;
&#xD;
          6. Extracorporeal membrane oxygenation (ECMO)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clark Howard, Prof. /MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University College, London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi site # 14</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi site #13</name>
      <address>
        <city>Modena</city>
        <zip>41124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLH and UCL 250 Euston Road</name>
      <address>
        <city>London</city>
        <zip>NW1 2BU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi site #4</name>
      <address>
        <city>London</city>
        <zip>SW10 9NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi site # 12</name>
      <address>
        <city>Southampton</city>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002632-75/results</url>
    <description>Study Record on EU Clinical Trials Register including results</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <results_first_submitted>March 16, 2023</results_first_submitted>
  <results_first_submitted_qc>May 31, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 23, 2023</results_first_posted>
  <last_update_submitted>May 31, 2023</last_update_submitted>
  <last_update_submitted_qc>May 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acute respiratory distress syndrome</keyword>
  <keyword>ARDS</keyword>
  <keyword>Adults</keyword>
  <keyword>Surfactant</keyword>
  <keyword>Poractant alfa (porcine surfactant, Curosurf®),</keyword>
  <keyword>Curosurf®</keyword>
  <keyword>Coronavirus disease (COVID-19)</keyword>
  <keyword>Coronavirus 2019 Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poractant alfa</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 2, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT04502433/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 27, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT04502433/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The planned 70 randomised patients in a 3:2 ratio, according to the inclusion and exclusion criteria. This was not achieved; owing to a global improvement in the pandemic situation in the countries where the study was performed (Italy, UK, US), patient recruitment was lower than expected (i.e. 22 patients were randomised, 14 patients and 8 patients in the poractant alfa and control groups, respectively); the study was terminated early before reaching the target sample size.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Control Cohort</title>
          <description>Patients receiving standard-of-care (SoC)</description>
        </group>
        <group group_id="P2">
          <title>Poractant Alfa Treated Cohort</title>
          <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intention-to-Treat (ITT) population used for this parameter.</population>
      <group_list>
        <group group_id="B1">
          <title>Control Cohort</title>
          <description>Patients receiving SoC</description>
        </group>
        <group group_id="B2">
          <title>Poractant Alfa Treated Cohort</title>
          <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="21"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.0" spread="18.2"/>
                    <measurement group_id="B2" value="63.6" spread="9.2"/>
                    <measurement group_id="B3" value="58.8" spread="14.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.44" spread="9.90"/>
                    <measurement group_id="B2" value="29.78" spread="5.05"/>
                    <measurement group_id="B3" value="32.32" spread="7.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Arterial Partial Pressure of Oxygen/Fraction of inspired oxygen (PaO2/FiO2) ratio</title>
          <description>The ratio of partial pressure of oxygen in arterial blood (PaO2) to the fraction of inspiratory oxygen concentration (FiO2) is an indicator of pulmonary shunt fraction. PaO2/FiO2 (P/F) ratio is used to classify severity of acute respiratory distress syndrome (ARDS).&#xD;
To calculate the P/F Ratio: PaO2 / FIO2. &quot;P&quot; represents PaO2 (arterial pO2) from the arterial blood gas. &quot;F&quot; represents the FIO2 - the fraction (percent) of inspired oxygen that the patient is receiving expressed as a decimal (40% oxygen = FIO2 of 0.40). P divided by F = P/F ratio</description>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="109.70" spread="51.15"/>
                    <measurement group_id="B2" value="111.85" spread="38.72"/>
                    <measurement group_id="B3" value="111.03" spread="42.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fraction of inspired oxygen (FiO2)</title>
          <description>The fraction of inspired oxygen, FiO2, is an estimation of the oxygen content a person inhales and is thus involved in gas exchange at the alveolar level.</description>
          <units>percentage of inspired oxygen</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.5" spread="18.1"/>
                    <measurement group_id="B2" value="65.0" spread="23.2"/>
                    <measurement group_id="B3" value="67.1" spread="21.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sequential Organ Failure Assessment (SOFA) score</title>
          <description>Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body (neurologic, blood, liver, kidney, and blood pressure/hemodynamics) and assigns a score based on the data obtained in each category.&#xD;
Total score ranged from 0 to 24 points; to be considered organ failure free, a patient had to have a score of 0.</description>
          <units>score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.0" spread="3.5"/>
                    <measurement group_id="B2" value="7.8" spread="4.6"/>
                    <measurement group_id="B3" value="7.5" spread="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Days Alive and Ventilator-free Days</title>
        <description>The number of days alive and ventilator-free days, defined as the number of days the patient is not receiving mechanical ventilation over the 21 days following randomisation.&#xD;
Mechanical ventilation was defined as invasive and non-invasive. The patient was defined as free of mechanical ventilation after 12 hours from the suspension of either invasive and non-invasive ventilation. Patients who died or were mechanically ventilated longer than this period were assessed as zero ventilator-free days.</description>
        <time_frame>up to 21 days</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics.&#xD;
Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days Alive and Ventilator-free Days</title>
          <description>The number of days alive and ventilator-free days, defined as the number of days the patient is not receiving mechanical ventilation over the 21 days following randomisation.&#xD;
Mechanical ventilation was defined as invasive and non-invasive. The patient was defined as free of mechanical ventilation after 12 hours from the suspension of either invasive and non-invasive ventilation. Patients who died or were mechanically ventilated longer than this period were assessed as zero ventilator-free days.</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics.&#xD;
Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="6.6"/>
                    <measurement group_id="O2" value="1.2" spread="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients Alive and Free of Respiratory Failure at Day 28</title>
        <description>The percentage of patients alive and free of respiratory failure (i.e. without need for mechanical ventilation, extracorporeal membrane oxygenation (ECMO), non-invasive ventilation, or high-flow nasal cannula oxygen delivery) at Day 28.</description>
        <time_frame>at Day 28</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics.&#xD;
Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Alive and Free of Respiratory Failure at Day 28</title>
          <description>The percentage of patients alive and free of respiratory failure (i.e. without need for mechanical ventilation, extracorporeal membrane oxygenation (ECMO), non-invasive ventilation, or high-flow nasal cannula oxygen delivery) at Day 28.</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics.&#xD;
Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0"/>
                    <measurement group_id="O2" value="15.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days Alive and Ventilator-Free at Day 28</title>
        <description>The number of days alive and ventilator-free (i.e. free of any mechanical ventilation for at least 12 hours) at Day 28.</description>
        <time_frame>at Day 28</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days Alive and Ventilator-Free at Day 28</title>
          <description>The number of days alive and ventilator-free (i.e. free of any mechanical ventilation for at least 12 hours) at Day 28.</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4" spread="10.2"/>
                    <measurement group_id="O2" value="1.7" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mortality at Day 21 and Day 28</title>
        <description>Mortality at Day 21 and Day 28 of the study by treatment group.</description>
        <time_frame>at Day 21 and at Day 28</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Mortality at Day 21 and Day 28</title>
          <description>Mortality at Day 21 and Day 28 of the study by treatment group.</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dead at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dead at Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days Alive and Free From Invasive Ventilation at Day 21 and Day 28</title>
        <description>The number of days alive and free from invasive ventilation at Day 21 and Day 28 is presented by treatment group.</description>
        <time_frame>Day 21 and Day 28</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days Alive and Free From Invasive Ventilation at Day 21 and Day 28</title>
          <description>The number of days alive and free from invasive ventilation at Day 21 and Day 28 is presented by treatment group.</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Days alive and free from invasive ventilation at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="15"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Days alive and free from invasive ventilation at Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="22"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days Alive and Free From Non-Invasive Ventilation at Day 21 and Day 28</title>
        <description>The number of days alive and free from non-invasive ventilation at Day 21 and Day 28 is presented by treatment group.</description>
        <time_frame>Day 21 and Day 28</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days Alive and Free From Non-Invasive Ventilation at Day 21 and Day 28</title>
          <description>The number of days alive and free from non-invasive ventilation at Day 21 and Day 28 is presented by treatment group.</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Days alive and free from non-invasive ventilation at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" lower_limit="0" upper_limit="21"/>
                    <measurement group_id="O2" value="21.0" lower_limit="0" upper_limit="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Days alive and free from non-invasive ventilation at Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.5" lower_limit="0" upper_limit="28"/>
                    <measurement group_id="O2" value="28.0" lower_limit="0" upper_limit="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Improvement in Severity Status at Day 28 or Discharge (Severity Score: Mild, Moderate, Severe, or Death)</title>
        <description>The severity status of patients at baseline and at Day 28/Discharge and the percentage of patients with improvement in severity status (i.e. a decrease of at least 1 point in severity status) at Day 28/Discharge relative to baseline is presented.&#xD;
Severity was assessed using a point score system: Severity score was defined as mild, moderate, severe (see below*), or death and was based on PaO2/FiO2 ratio and patient status at Day 28/Discharge and numerically rated from 1-4, respectively. An improvement in severity was defined as a decrease of at least 1 point between baseline and Day 28/Discharge.&#xD;
At Day 28 the last follow up evaluation took place on the ICU if, still requiring critical care, or by phone call if the patient has been discharged from ICU by that time.&#xD;
*Mild: 200 mmHg &lt; PaO2/FiO2 ratio ≤300 mmHg; Moderate: 100 mmHg &lt; PaO2/FiO2 ratio ≤200 mmHg; Severe: PaO2/FiO2 ratio ≤100 mmHg</description>
        <time_frame>Day 28 or Discharge, whichever comes first</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Improvement in Severity Status at Day 28 or Discharge (Severity Score: Mild, Moderate, Severe, or Death)</title>
          <description>The severity status of patients at baseline and at Day 28/Discharge and the percentage of patients with improvement in severity status (i.e. a decrease of at least 1 point in severity status) at Day 28/Discharge relative to baseline is presented.&#xD;
Severity was assessed using a point score system: Severity score was defined as mild, moderate, severe (see below*), or death and was based on PaO2/FiO2 ratio and patient status at Day 28/Discharge and numerically rated from 1-4, respectively. An improvement in severity was defined as a decrease of at least 1 point between baseline and Day 28/Discharge.&#xD;
At Day 28 the last follow up evaluation took place on the ICU if, still requiring critical care, or by phone call if the patient has been discharged from ICU by that time.&#xD;
*Mild: 200 mmHg &lt; PaO2/FiO2 ratio ≤300 mmHg; Moderate: 100 mmHg &lt; PaO2/FiO2 ratio ≤200 mmHg; Severe: PaO2/FiO2 ratio ≤100 mmHg</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Arterial Partial Pressure of Oxygen / Fraction of Inspired Oxygen (PaO2/FiO2) Ratio at Each Timepoint</title>
        <description>Change from baseline in PaO2/FiO2 ratio measured at each timepoint following administration of each dose in the treatment and control group.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Partial pressure of oxygen (PaO2) is the oxygen pressure in arterial blood. The fraction of inspired oxygen (FiO2) is the concentration of oxygen in the gas mixture.&#xD;
The fraction of inspired oxygen (PaO2/FiO2) ratio is widely used in ICUs as an indicator of oxygenation status.</description>
        <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.&#xD;
At each time point the number of patients that contributed with a result value is indicated for both study arms.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Arterial Partial Pressure of Oxygen / Fraction of Inspired Oxygen (PaO2/FiO2) Ratio at Each Timepoint</title>
          <description>Change from baseline in PaO2/FiO2 ratio measured at each timepoint following administration of each dose in the treatment and control group.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Partial pressure of oxygen (PaO2) is the oxygen pressure in arterial blood. The fraction of inspired oxygen (FiO2) is the concentration of oxygen in the gas mixture.&#xD;
The fraction of inspired oxygen (PaO2/FiO2) ratio is widely used in ICUs as an indicator of oxygenation status.</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.&#xD;
At each time point the number of patients that contributed with a result value is indicated for both study arms.</population>
          <units>mmHg</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.00" lower_limit="-53.50" upper_limit="197.08"/>
                    <measurement group_id="O2" value="13.00" lower_limit="-67.50" upper_limit="67.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.00" lower_limit="-60.58" upper_limit="220.00"/>
                    <measurement group_id="O2" value="10.01" lower_limit="-60.00" upper_limit="82.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.00" lower_limit="-69.42" upper_limit="235.00"/>
                    <measurement group_id="O2" value="2.36" lower_limit="-57.01" upper_limit="67.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.00" lower_limit="-104.92" upper_limit="182.00"/>
                    <measurement group_id="O2" value="10.00" lower_limit="-41.02" upper_limit="143.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.00" lower_limit="-103.80" upper_limit="203.00"/>
                    <measurement group_id="O2" value="31.00" lower_limit="-35.40" upper_limit="165.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.00" lower_limit="-83.11" upper_limit="183.00"/>
                    <measurement group_id="O2" value="15.65" lower_limit="-38.00" upper_limit="89.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>54 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.00" lower_limit="-132.19" upper_limit="304.00"/>
                    <measurement group_id="O2" value="25.07" lower_limit="-54.61" upper_limit="98.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-103.06" upper_limit="308.00"/>
                    <measurement group_id="O2" value="7.00" lower_limit="-56.00" upper_limit="120.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.40" lower_limit="-39.41" upper_limit="278.00"/>
                    <measurement group_id="O2" value="-1.00" lower_limit="-41.85" upper_limit="67.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>28 day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.50" lower_limit="-21.00" upper_limit="128.00"/>
                    <measurement group_id="O2" value="20.00" lower_limit="-93.45" upper_limit="135.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients Alive and With PaO2/FiO2 Ratio Improvement &gt;20% Compared to Baseline at Each Timepoint</title>
        <description>The percentages of patients in categories of PaO2/FiO2 ratio improvement compared to baseline (&gt;20%) at all timepoints post-baseline are summarised by treatment group.</description>
        <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Alive and With PaO2/FiO2 Ratio Improvement &gt;20% Compared to Baseline at Each Timepoint</title>
          <description>The percentages of patients in categories of PaO2/FiO2 ratio improvement compared to baseline (&gt;20%) at all timepoints post-baseline are summarised by treatment group.</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.5"/>
                    <measurement group_id="O2" value="46.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.5"/>
                    <measurement group_id="O2" value="41.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="38.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.1"/>
                    <measurement group_id="O2" value="38.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="53.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="46.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>54 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.4"/>
                    <measurement group_id="O2" value="58.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.6"/>
                    <measurement group_id="O2" value="38.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3"/>
                    <measurement group_id="O2" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>28 day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0"/>
                    <measurement group_id="O2" value="27.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fraction of Inspired Oxygen (FiO2) at Each Timepoint</title>
        <description>The FiO2 at baseline and at selected timepoints post-baseline was measured. Results are shown as changes from baseline, summarised by treatment group.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline. The unit for the variable is percent (%) and what is reported is an absolute change.</description>
        <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fraction of Inspired Oxygen (FiO2) at Each Timepoint</title>
          <description>The FiO2 at baseline and at selected timepoints post-baseline was measured. Results are shown as changes from baseline, summarised by treatment group.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline. The unit for the variable is percent (%) and what is reported is an absolute change.</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>percent (absolute change)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.2" lower_limit="-30.0" upper_limit="20.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-35.0" upper_limit="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.5" lower_limit="-25.0" upper_limit="20.0"/>
                    <measurement group_id="O2" value="-5.0" lower_limit="-50.0" upper_limit="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-30.0" upper_limit="15.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-45.0" upper_limit="55.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.0" lower_limit="-30.0" upper_limit="5.7"/>
                    <measurement group_id="O2" value="-5.0" lower_limit="-50.0" upper_limit="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.0" lower_limit="-30.0" upper_limit="15.0"/>
                    <measurement group_id="O2" value="-10.0" lower_limit="-50.0" upper_limit="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.5" lower_limit="-35.0" upper_limit="45.7"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-55.0" upper_limit="55.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>54 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.5" lower_limit="-50.0" upper_limit="15.7"/>
                    <measurement group_id="O2" value="-5.0" lower_limit="-55.0" upper_limit="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="-40.0" upper_limit="20.0"/>
                    <measurement group_id="O2" value="-5.0" lower_limit="-60.0" upper_limit="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.9" lower_limit="-50.0" upper_limit="10.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-55.0" upper_limit="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>28 day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.3" lower_limit="-60.0" upper_limit="10.0"/>
                    <measurement group_id="O2" value="-7.5" lower_limit="-60.0" upper_limit="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of ICU Stay (Days) at Day 28</title>
        <description>The length of ICU stay (days) at Day 28 is presented by treatment by treatment group. Patients who died or were mechanically ventilated longer than this period were assigned with 28 days.</description>
        <time_frame>up to 28 days</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Length of ICU Stay (Days) at Day 28</title>
          <description>The length of ICU stay (days) at Day 28 is presented by treatment by treatment group. Patients who died or were mechanically ventilated longer than this period were assigned with 28 days.</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.0" lower_limit="9" upper_limit="28"/>
                    <measurement group_id="O2" value="28.0" lower_limit="12" upper_limit="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients Alive and Out of Intensive Care Unit (ICU) at Day 28</title>
        <description>The percentage of patients alive and out of ICU at Day 28 is presented by treatment group.</description>
        <time_frame>Day 28</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Alive and Out of Intensive Care Unit (ICU) at Day 28</title>
          <description>The percentage of patients alive and out of ICU at Day 28 is presented by treatment group.</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.5"/>
                    <measurement group_id="O2" value="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Delta Sequential Organ Failure Assessment (SOFA) Score and Sub-component Measure at Day 3 and Day 28</title>
        <description>The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body. The SOFA score was used to determine the extent of organ failure at Day 3 and Day 28/Discharge with respect to a pre-randomisation assessment.&#xD;
The total score was derived from six sub-scores system categories: respiratory, neurological, cardiovascular, hepatic, coagulation, and renal systems; respective sub-scores were calculated primarily considering PaO2/FiO2 ratio, Glasgow Coma Scale, mean arterial pressure (MAP) or requirement for vasopressor administration, bilirubin levels, platelet levels and creatinine levels or daily urine output.&#xD;
A score of 0, 1, 2, 3, or 4) was assigned to each of the six system category. The total score ranged from 0 (min) to 24 (max) points. To be considered organ failure free, a patient had to have a score of 0.</description>
        <time_frame>Day 3 and Day 28 or discharge -- whichever comes first</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Delta Sequential Organ Failure Assessment (SOFA) Score and Sub-component Measure at Day 3 and Day 28</title>
          <description>The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body. The SOFA score was used to determine the extent of organ failure at Day 3 and Day 28/Discharge with respect to a pre-randomisation assessment.&#xD;
The total score was derived from six sub-scores system categories: respiratory, neurological, cardiovascular, hepatic, coagulation, and renal systems; respective sub-scores were calculated primarily considering PaO2/FiO2 ratio, Glasgow Coma Scale, mean arterial pressure (MAP) or requirement for vasopressor administration, bilirubin levels, platelet levels and creatinine levels or daily urine output.&#xD;
A score of 0, 1, 2, 3, or 4) was assigned to each of the six system category. The total score ranged from 0 (min) to 24 (max) points. To be considered organ failure free, a patient had to have a score of 0.</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SOFA score -- Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="-5" upper_limit="5"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-5" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SOFA score -- Day 28 / Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" lower_limit="-6" upper_limit="11"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-4" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Respiratory system score -- Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-1" upper_limit="1"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-1" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Respiratory system score -- Day 28 / Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" lower_limit="-1" upper_limit="0"/>
                    <measurement group_id="O2" value="-0.5" lower_limit="-1" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neurological system score -- Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-4" upper_limit="2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neurological system score -- Day 28 / Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" lower_limit="-4" upper_limit="2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-3" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiovascular system score -- Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-1" upper_limit="1"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-3" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiovascular system score -- Day 28 / Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-1" upper_limit="3"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-2" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hepatic system score -- Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-1" upper_limit="0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-2" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hepatic system score -- Day 28 / Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coagulatory system score -- Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-1" upper_limit="1"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-1" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coagulatory system score -- Day 28 / Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-1" upper_limit="3"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-1" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renal system score -- Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renal system score -- Day 28 / Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients Alive and Free of Organ Failure (SOFA Score=0)</title>
        <description>The percentage of patients alive and organ failure free (defined as SOFA score=0) at Day 28/Discharge is presented by treatment group.&#xD;
The total score was derived from six sub-scores system categories: respiratory, neurological, cardiovascular, hepatic, coagulation, and renal systems; respective sub-scores were calculated primarily considering PaO2/FiO2 ratio, Glasgow Coma Scale, mean arterial pressure (MAP) or requirement for vasopressor administration, bilirubin levels, platelet levels and creatinine levels or daily urine output.&#xD;
A score of 0, 1, 2, 3, or 4) was assigned to each of the six system category. The total score ranged from 0 (min) to 24 (max) points. To be considered organ failure free, a patient had to have a score of 0.</description>
        <time_frame>at day 28 or discharge -- whichever comes first</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Alive and Free of Organ Failure (SOFA Score=0)</title>
          <description>The percentage of patients alive and organ failure free (defined as SOFA score=0) at Day 28/Discharge is presented by treatment group.&#xD;
The total score was derived from six sub-scores system categories: respiratory, neurological, cardiovascular, hepatic, coagulation, and renal systems; respective sub-scores were calculated primarily considering PaO2/FiO2 ratio, Glasgow Coma Scale, mean arterial pressure (MAP) or requirement for vasopressor administration, bilirubin levels, platelet levels and creatinine levels or daily urine output.&#xD;
A score of 0, 1, 2, 3, or 4) was assigned to each of the six system category. The total score ranged from 0 (min) to 24 (max) points. To be considered organ failure free, a patient had to have a score of 0.</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ventilatory Parameter: Tidal Volume -- Change From Baseline in Tidal Volume (mL/kg BW) at All Timepoints up to Day 3 (72 Hours) and at Day 28</title>
        <description>Ventilatory parameter: Change from baseline in tidal volume (mL/kg BW) at all timepoints up to Day 3 (72 hours) and at Day 28.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Tidal volume is the amount of air that moves in or out of the lungs with each respiratory cycle.</description>
        <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Ventilatory Parameter: Tidal Volume -- Change From Baseline in Tidal Volume (mL/kg BW) at All Timepoints up to Day 3 (72 Hours) and at Day 28</title>
          <description>Ventilatory parameter: Change from baseline in tidal volume (mL/kg BW) at all timepoints up to Day 3 (72 hours) and at Day 28.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Tidal volume is the amount of air that moves in or out of the lungs with each respiratory cycle.</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>mL/kg BW</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.50" lower_limit="-101.0" upper_limit="152.0"/>
                    <measurement group_id="O2" value="-1.00" lower_limit="-90.0" upper_limit="93.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.50" lower_limit="-67.0" upper_limit="194.0"/>
                    <measurement group_id="O2" value="13.00" lower_limit="-170.0" upper_limit="129.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.00" lower_limit="-252.0" upper_limit="166.0"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-170.0" upper_limit="147.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.00" lower_limit="-53.0" upper_limit="514.8"/>
                    <measurement group_id="O2" value="-18.00" lower_limit="-119.0" upper_limit="79.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.50" lower_limit="-219.0" upper_limit="532.4"/>
                    <measurement group_id="O2" value="13.40" lower_limit="-67.0" upper_limit="146.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-34.00" lower_limit="-125.0" upper_limit="512.0"/>
                    <measurement group_id="O2" value="-17.00" lower_limit="-160.0" upper_limit="230.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>54 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.00" lower_limit="-250.0" upper_limit="521.0"/>
                    <measurement group_id="O2" value="30.00" lower_limit="-116.0" upper_limit="320.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.00" lower_limit="-129.0" upper_limit="233.0"/>
                    <measurement group_id="O2" value="17.00" lower_limit="-141.0" upper_limit="256.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.50" lower_limit="-272.0" upper_limit="271.6"/>
                    <measurement group_id="O2" value="11.50" lower_limit="-136.0" upper_limit="234.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>28 day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.00" lower_limit="-257.0" upper_limit="35.8"/>
                    <measurement group_id="O2" value="-90.50" lower_limit="-325.0" upper_limit="-26.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ventilatory Parameter: Respiratory Rate -- Change From Baseline in Respiratory Rate (Breaths/Minute) at All Timepoints up to Day 3 (72 Hours) and at Day 28</title>
        <description>Ventilatory parameter: Change from baseline in respiratory rate (breaths/minute) at all timepoints up to Day 3 (72 hours) and at Day 28.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Respiratory rate is the number of breaths taken per minute.</description>
        <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Ventilatory Parameter: Respiratory Rate -- Change From Baseline in Respiratory Rate (Breaths/Minute) at All Timepoints up to Day 3 (72 Hours) and at Day 28</title>
          <description>Ventilatory parameter: Change from baseline in respiratory rate (breaths/minute) at all timepoints up to Day 3 (72 hours) and at Day 28.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Respiratory rate is the number of breaths taken per minute.</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>breaths/minute</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-4.0" upper_limit="5.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-2.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-1.0" upper_limit="5.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-2.0" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.50" lower_limit="-1.0" upper_limit="8.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-2.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="-9.0" upper_limit="17.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-3.0" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="-11.0" upper_limit="11.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-4.0" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.50" lower_limit="-11.0" upper_limit="11.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-6.0" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>54 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-8.0" upper_limit="14.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-15.0" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-10.0" upper_limit="13.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-15.0" upper_limit="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="-6.0" upper_limit="13.0"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-14.0" upper_limit="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>28 day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" lower_limit="-6.0" upper_limit="12.0"/>
                    <measurement group_id="O2" value="14.0" lower_limit="2.0" upper_limit="26.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ventilatory Parameter: Dynamic Compliance -- Change From Baseline in Dynamic Compliance (mL/cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28</title>
        <description>Ventilatory parameter: Change from baseline in dynamic compliance (mL/cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Dynamic compliance: is the continuous measurement of pulmonary compliance calculated at each point representing schematic changes during rhythmic breathing. Dynamic compliance monitors both elastic and airway resistance.</description>
        <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.&#xD;
At each time point the number of patients that contributed with a result value is indicated for both study arms.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Ventilatory Parameter: Dynamic Compliance -- Change From Baseline in Dynamic Compliance (mL/cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28</title>
          <description>Ventilatory parameter: Change from baseline in dynamic compliance (mL/cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Dynamic compliance: is the continuous measurement of pulmonary compliance calculated at each point representing schematic changes during rhythmic breathing. Dynamic compliance monitors both elastic and airway resistance.</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.&#xD;
At each time point the number of patients that contributed with a result value is indicated for both study arms.</population>
          <units>mL/cmH2O</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" lower_limit="-4.0" upper_limit="9.2"/>
                    <measurement group_id="O2" value="0.70" lower_limit="-6.3" upper_limit="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" lower_limit="-4.0" upper_limit="15.5"/>
                    <measurement group_id="O2" value="-0.70" lower_limit="-4.0" upper_limit="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.20" lower_limit="-11.7" upper_limit="6.3"/>
                    <measurement group_id="O2" value="-0.55" lower_limit="-5.3" upper_limit="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.50" lower_limit="-1.0" upper_limit="46.0"/>
                    <measurement group_id="O2" value="1.30" lower_limit="-0.6" upper_limit="188.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" lower_limit="-1.9" upper_limit="63.0"/>
                    <measurement group_id="O2" value="2.25" lower_limit="-0.4" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" lower_limit="-10.5" upper_limit="103.0"/>
                    <measurement group_id="O2" value="0.52" lower_limit="-12.8" upper_limit="14.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>54 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.80" lower_limit="-23.9" upper_limit="105.0"/>
                    <measurement group_id="O2" value="0.98" lower_limit="-4.1" upper_limit="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.85" lower_limit="-5.5" upper_limit="7.0"/>
                    <measurement group_id="O2" value="-0.05" lower_limit="-3.9" upper_limit="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.25" lower_limit="-25.7" upper_limit="7.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-10.5" upper_limit="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>28 day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.25" lower_limit="-24.5" upper_limit="14.0"/>
                    <measurement group_id="O2" value="-3.10" lower_limit="-13.0" upper_limit="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ventilatory Parameter: Static Compliance -- Change From Baseline in Static Compliance (mL/cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28</title>
        <description>Ventilatory parameter: static compliance -- change from baseline in static compliance (mL/cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
At each time point the number of patients that contributed with a result value is indicated for both study arms.&#xD;
Static Compliance: represents pulmonary compliance at a given fixed volume when there is no airflow, and muscles are relaxed.</description>
        <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Ventilatory Parameter: Static Compliance -- Change From Baseline in Static Compliance (mL/cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28</title>
          <description>Ventilatory parameter: static compliance -- change from baseline in static compliance (mL/cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
At each time point the number of patients that contributed with a result value is indicated for both study arms.&#xD;
Static Compliance: represents pulmonary compliance at a given fixed volume when there is no airflow, and muscles are relaxed.</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>mL/cmH2O</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.00" lower_limit="-4.0" upper_limit="9.2"/>
                    <measurement group_id="O2" value="0.40" lower_limit="-4.0" upper_limit="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.15" lower_limit="-4.0" upper_limit="8.5"/>
                    <measurement group_id="O2" value="-0.81" lower_limit="-3.5" upper_limit="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.54" lower_limit="0.0" upper_limit="6.3"/>
                    <measurement group_id="O2" value="-0.40" lower_limit="-3.6" upper_limit="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.00" lower_limit="-1.0" upper_limit="8.0"/>
                    <measurement group_id="O2" value="1.30" lower_limit="0.2" upper_limit="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.50" lower_limit="-1.9" upper_limit="7.5"/>
                    <measurement group_id="O2" value="2.10" lower_limit="-0.4" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.50" lower_limit="-10.5" upper_limit="7.4"/>
                    <measurement group_id="O2" value="-0.40" lower_limit="-5.7" upper_limit="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>54 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.80" lower_limit="-23.9" upper_limit="7.1"/>
                    <measurement group_id="O2" value="-0.26" lower_limit="-3.7" upper_limit="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.85" lower_limit="-5.5" upper_limit="7.0"/>
                    <measurement group_id="O2" value="-0.40" lower_limit="-3.2" upper_limit="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" lower_limit="-25.7" upper_limit="7.0"/>
                    <measurement group_id="O2" value="0.30" lower_limit="-1.3" upper_limit="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>28 day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.50" lower_limit="-24.5" upper_limit="-24.5"/>
                    <measurement group_id="O2" value="-2.70" lower_limit="-13.0" upper_limit="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ventilatory Parameter: Positive End-Expiratory Pressure (PEEP) -- Change From Baseline in PEEP (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28</title>
        <description>Ventilatory parameter: Positive End-Expiratory Pressure -- Change from baseline in PEEP (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
At each time point the number of patients that contributed with a result value is indicated for both study arms.&#xD;
Positive end-expiratory pressure (PEEP) is the positive pressure that will remain in the airways at the end of the respiratory cycle (end of exhalation) that is greater than the atmospheric pressure in mechanically ventilated patients.</description>
        <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Ventilatory Parameter: Positive End-Expiratory Pressure (PEEP) -- Change From Baseline in PEEP (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28</title>
          <description>Ventilatory parameter: Positive End-Expiratory Pressure -- Change from baseline in PEEP (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
At each time point the number of patients that contributed with a result value is indicated for both study arms.&#xD;
Positive end-expiratory pressure (PEEP) is the positive pressure that will remain in the airways at the end of the respiratory cycle (end of exhalation) that is greater than the atmospheric pressure in mechanically ventilated patients.</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>cmH2O</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-0.3" upper_limit="2.0"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-4.0" upper_limit="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" lower_limit="0.0" upper_limit="2.0"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-2.0" upper_limit="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" lower_limit="-3.0" upper_limit="2.0"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-4.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-4.0" upper_limit="2.0"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-4.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-5.0" upper_limit="5.0"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-4.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-8.0" upper_limit="3.0"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-4.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>54 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.50" lower_limit="-10.0" upper_limit="3.0"/>
                    <measurement group_id="O2" value="-0.50" lower_limit="-7.6" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.45" lower_limit="-10.0" upper_limit="3.0"/>
                    <measurement group_id="O2" value="-0.50" lower_limit="-6.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.00" lower_limit="-10.0" upper_limit="3.0"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-2.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>28 day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.20" lower_limit="-11.8" upper_limit="-1.0"/>
                    <measurement group_id="O2" value="-2.00" lower_limit="-4.0" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ventilatory Parameter: Peak Inspiratory Pressure -- Change From Baseline in Peak Inspiratory Pressure (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28</title>
        <description>Ventilatory parameter: Peak Inspiratory Pressure -- Change from baseline in peak inspiratory pressure (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
At each time point the number of patients that contributed with a result value is indicated for both study arms.&#xD;
Peak inspiratory pressure (PIP) is the highest level of pressure applied to the lungs during inhalation. In mechanical ventilation the number reflects a positive pressure in centimetres of water pressure (cmH2O).</description>
        <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Ventilatory Parameter: Peak Inspiratory Pressure -- Change From Baseline in Peak Inspiratory Pressure (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28</title>
          <description>Ventilatory parameter: Peak Inspiratory Pressure -- Change from baseline in peak inspiratory pressure (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
At each time point the number of patients that contributed with a result value is indicated for both study arms.&#xD;
Peak inspiratory pressure (PIP) is the highest level of pressure applied to the lungs during inhalation. In mechanical ventilation the number reflects a positive pressure in centimetres of water pressure (cmH2O).</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>cmH2O</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-18.0" upper_limit="5.0"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-8.0" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" lower_limit="-0.1" upper_limit="5.0"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-8.0" upper_limit="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" lower_limit="-4.1" upper_limit="6.0"/>
                    <measurement group_id="O2" value="-0.50" lower_limit="-8.0" upper_limit="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="-4.7" upper_limit="6.0"/>
                    <measurement group_id="O2" value="-2.00" lower_limit="-6.0" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" lower_limit="-4.7" upper_limit="6.0"/>
                    <measurement group_id="O2" value="-1.00" lower_limit="-8.0" upper_limit="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-5.4" upper_limit="10.0"/>
                    <measurement group_id="O2" value="-2.00" lower_limit="-8.0" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>54 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" lower_limit="-5.5" upper_limit="8.0"/>
                    <measurement group_id="O2" value="-3.00" lower_limit="-8.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-6.1" upper_limit="7.0"/>
                    <measurement group_id="O2" value="-3.00" lower_limit="-7.0" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.50" lower_limit="-7.0" upper_limit="12.0"/>
                    <measurement group_id="O2" value="-3.00" lower_limit="-13.0" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>28 day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" lower_limit="-3.5" upper_limit="5.0"/>
                    <measurement group_id="O2" value="-4.00" lower_limit="-16.0" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ventilatory Parameter: Plateau Pressure -- Change From Baseline in Plateau Pressure (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28</title>
        <description>Ventilatory parameter: Plateau Pressure -- Change from baseline in plateau pressure (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
At each time point the number of patients that contributed with a result value is indicated for both study arms.&#xD;
Plateau pressure is the pressure that is applied by the mechanical ventilator to the small airways and alveoli.</description>
        <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Ventilatory Parameter: Plateau Pressure -- Change From Baseline in Plateau Pressure (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28</title>
          <description>Ventilatory parameter: Plateau Pressure -- Change from baseline in plateau pressure (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
At each time point the number of patients that contributed with a result value is indicated for both study arms.&#xD;
Plateau pressure is the pressure that is applied by the mechanical ventilator to the small airways and alveoli.</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>cmH2O</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.25" lower_limit="0.0" upper_limit="3.0"/>
                    <measurement group_id="O2" value="-1.00" lower_limit="-8.0" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" lower_limit="0.0" upper_limit="3.0"/>
                    <measurement group_id="O2" value="-1.50" lower_limit="-8.0" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" lower_limit="-5.0" upper_limit="6.0"/>
                    <measurement group_id="O2" value="-1.50" lower_limit="-8.0" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-1.0" upper_limit="6.0"/>
                    <measurement group_id="O2" value="-3.00" lower_limit="-7.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="-2.0" upper_limit="4.0"/>
                    <measurement group_id="O2" value="-2.00" lower_limit="-8.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" lower_limit="-4.0" upper_limit="10.0"/>
                    <measurement group_id="O2" value="-3.00" lower_limit="-8.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>54 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.50" lower_limit="-4.0" upper_limit="10.0"/>
                    <measurement group_id="O2" value="-3.50" lower_limit="-8.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" lower_limit="-5.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="-2.50" lower_limit="-7.0" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.50" lower_limit="-8.0" upper_limit="11.0"/>
                    <measurement group_id="O2" value="-3.00" lower_limit="-8.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>28 day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" lower_limit="-2.0" upper_limit="6.0"/>
                    <measurement group_id="O2" value="-4.00" lower_limit="-16.0" upper_limit="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Blood Gas Analysis Acid-base Balance Parameters: Change From Baseline in Blood Gas Analysis Acid-base Balance Parameters -- pH</title>
        <description>Change from baseline in blood gas analysis acid-base balance parameters -- pH.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Arterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.</description>
        <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Gas Analysis Acid-base Balance Parameters: Change From Baseline in Blood Gas Analysis Acid-base Balance Parameters -- pH</title>
          <description>Change from baseline in blood gas analysis acid-base balance parameters -- pH.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Arterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>pH</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0000" lower_limit="-0.020" upper_limit="0.100"/>
                    <measurement group_id="O2" value="0.0080" lower_limit="-0.240" upper_limit="0.127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0050" lower_limit="-0.080" upper_limit="0.080"/>
                    <measurement group_id="O2" value="0.0100" lower_limit="-0.150" upper_limit="0.149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0315" lower_limit="-0.110" upper_limit="0.150"/>
                    <measurement group_id="O2" value="0.0160" lower_limit="-0.150" upper_limit="0.110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0300" lower_limit="-0.090" upper_limit="0.150"/>
                    <measurement group_id="O2" value="0.0100" lower_limit="-0.120" upper_limit="0.210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0050" lower_limit="-0.110" upper_limit="0.180"/>
                    <measurement group_id="O2" value="0.0260" lower_limit="-0.080" upper_limit="0.170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0050" lower_limit="-0.100" upper_limit="0.160"/>
                    <measurement group_id="O2" value="0.0300" lower_limit="-0.320" upper_limit="0.170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>54 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0500" lower_limit="-0.150" upper_limit="0.457"/>
                    <measurement group_id="O2" value="0.0185" lower_limit="-0.230" upper_limit="0.170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0500" lower_limit="-0.140" upper_limit="0.348"/>
                    <measurement group_id="O2" value="0.0000" lower_limit="-0.369" upper_limit="0.140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0400" lower_limit="-0.170" upper_limit="0.270"/>
                    <measurement group_id="O2" value="0.0120" lower_limit="-0.369" upper_limit="0.180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>28 day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0400" lower_limit="-0.050" upper_limit="-0.021"/>
                    <measurement group_id="O2" value="0.0500" lower_limit="-0.010" upper_limit="0.230"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ICU Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0450" lower_limit="0.045" upper_limit="0.045"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Partial Pressure of Carbon Dioxide (pCO2)</title>
        <description>Change from baseline in blood gas analysis acid-base balance parameter -- pCO2.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Arterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.</description>
        <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Partial Pressure of Carbon Dioxide (pCO2)</title>
          <description>Change from baseline in blood gas analysis acid-base balance parameter -- pCO2.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Arterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>mmHg</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.210" lower_limit="-10.40" upper_limit="5.00"/>
                    <measurement group_id="O2" value="1.535" lower_limit="-14.25" upper_limit="49.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.150" lower_limit="-11.00" upper_limit="11.00"/>
                    <measurement group_id="O2" value="1.730" lower_limit="-21.76" upper_limit="22.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.610" lower_limit="-19.00" upper_limit="18.00"/>
                    <measurement group_id="O2" value="-2.000" lower_limit="-29.26" upper_limit="18.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.700" lower_limit="-11.40" upper_limit="10.60"/>
                    <measurement group_id="O2" value="1.880" lower_limit="-21.50" upper_limit="20.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.350" lower_limit="-15.00" upper_limit="23.00"/>
                    <measurement group_id="O2" value="1.720" lower_limit="-13.50" upper_limit="12.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.500" lower_limit="-11.00" upper_limit="10.20"/>
                    <measurement group_id="O2" value="0.300" lower_limit="-14.50" upper_limit="16.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>54 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.600" lower_limit="-38.50" upper_limit="13.60"/>
                    <measurement group_id="O2" value="-1.500" lower_limit="-13.00" upper_limit="30.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.400" lower_limit="-5.40" upper_limit="28.00"/>
                    <measurement group_id="O2" value="-0.230" lower_limit="-10.00" upper_limit="19.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" lower_limit="-10.87" upper_limit="33.00"/>
                    <measurement group_id="O2" value="0.750" lower_limit="-18.00" upper_limit="33.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>28 day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.150" lower_limit="-8.00" upper_limit="52.00"/>
                    <measurement group_id="O2" value="12.000" lower_limit="-13.40" upper_limit="30.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ICU Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-9.600" lower_limit="-9.60" upper_limit="-9.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Partial Pressure of Oxygen (pO2)</title>
        <description>Change from baseline in blood gas analysis acid-base balance parameter -- pO2.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Arterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.</description>
        <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Partial Pressure of Oxygen (pO2)</title>
          <description>Change from baseline in blood gas analysis acid-base balance parameter -- pO2.&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Arterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>mmHg</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.500" lower_limit="-9.00" upper_limit="210.01"/>
                    <measurement group_id="O2" value="6.550" lower_limit="-14.60" upper_limit="165.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.500" lower_limit="-8.85" upper_limit="158.70"/>
                    <measurement group_id="O2" value="1.000" lower_limit="-20.78" upper_limit="50.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.000" lower_limit="-6.30" upper_limit="82.70"/>
                    <measurement group_id="O2" value="1.100" lower_limit="-19.28" upper_limit="98.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.000" lower_limit="-11.40" upper_limit="181.10"/>
                    <measurement group_id="O2" value="2.000" lower_limit="-25.28" upper_limit="29.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.000" lower_limit="-13.30" upper_limit="171.10"/>
                    <measurement group_id="O2" value="2.600" lower_limit="-16.35" upper_limit="28.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.250" lower_limit="-10.30" upper_limit="63.10"/>
                    <measurement group_id="O2" value="0.000" lower_limit="-19.20" upper_limit="52.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>54 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.300" lower_limit="-23.33" upper_limit="116.10"/>
                    <measurement group_id="O2" value="2.250" lower_limit="-29.56" upper_limit="43.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.000" lower_limit="-13.05" upper_limit="156.10"/>
                    <measurement group_id="O2" value="0.000" lower_limit="-32.26" upper_limit="21.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.000" lower_limit="-6.30" upper_limit="103.10"/>
                    <measurement group_id="O2" value="5.100" lower_limit="-7.00" upper_limit="50.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>28 day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.100" lower_limit="-7.00" upper_limit="33.00"/>
                    <measurement group_id="O2" value="-7.700" lower_limit="-26.78" upper_limit="34.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ICU Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-10.730" lower_limit="-10.73" upper_limit="-10.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Bicarbonate (HCO3)</title>
        <description>Change from baseline in blood gas analysis acid-base balance parameter -- Bicarbonate (HCO3).&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Measured at 6-12-24h after each poractant alfa administration up to 72 hours and at similar timepoints in the control group (6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation) and then every 24 hours till the patient is discharged from the ICU</description>
        <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Bicarbonate (HCO3)</title>
          <description>Change from baseline in blood gas analysis acid-base balance parameter -- Bicarbonate (HCO3).&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
Measured at 6-12-24h after each poractant alfa administration up to 72 hours and at similar timepoints in the control group (6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation) and then every 24 hours till the patient is discharged from the ICU</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>mmol/L</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.05" lower_limit="-1.1" upper_limit="19.3"/>
                    <measurement group_id="O2" value="0.70" lower_limit="-3.8" upper_limit="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.10" lower_limit="-0.6" upper_limit="5.0"/>
                    <measurement group_id="O2" value="1.30" lower_limit="-2.4" upper_limit="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.65" lower_limit="-3.5" upper_limit="6.7"/>
                    <measurement group_id="O2" value="1.80" lower_limit="-2.4" upper_limit="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.30" lower_limit="-3.0" upper_limit="5.7"/>
                    <measurement group_id="O2" value="2.30" lower_limit="-2.4" upper_limit="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.75" lower_limit="-2.8" upper_limit="7.5"/>
                    <measurement group_id="O2" value="2.70" lower_limit="-2.7" upper_limit="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.60" lower_limit="-4.1" upper_limit="7.8"/>
                    <measurement group_id="O2" value="3.50" lower_limit="-13.4" upper_limit="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>54 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.80" lower_limit="-19.1" upper_limit="8.9"/>
                    <measurement group_id="O2" value="2.10" lower_limit="-11.4" upper_limit="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.30" lower_limit="-3.9" upper_limit="10.7"/>
                    <measurement group_id="O2" value="2.80" lower_limit="-2.9" upper_limit="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" lower_limit="-4.5" upper_limit="10.4"/>
                    <measurement group_id="O2" value="4.00" lower_limit="0.6" upper_limit="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>28 day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.90" lower_limit="-6.4" upper_limit="33.0"/>
                    <measurement group_id="O2" value="13.20" lower_limit="5.3" upper_limit="17.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ICU Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-3.90" lower_limit="-3.90" upper_limit="-3.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Blood Parameter -- Lactate</title>
        <description>Change from baseline in blood parameter -- Lactate&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
At each time point the number of patients that contributed with a result value is indicated for both study arms.&#xD;
Arterial blood lactate was measured at 6, 12, 24, 30, 36, 48, 54, 60, and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.</description>
        <time_frame>up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28</time_frame>
        <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Blood Parameter -- Lactate</title>
          <description>Change from baseline in blood parameter -- Lactate&#xD;
The change was calculated from two time points as the value at the later time point minus the value at baseline.&#xD;
At each time point the number of patients that contributed with a result value is indicated for both study arms.&#xD;
Arterial blood lactate was measured at 6, 12, 24, 30, 36, 48, 54, 60, and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.</description>
          <population>Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.&#xD;
Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.</population>
          <units>mmol/L</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" lower_limit="-0.5" upper_limit="1.1"/>
                    <measurement group_id="O2" value="-0.05" lower_limit="-1.0" upper_limit="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.55" lower_limit="-0.8" upper_limit="1.8"/>
                    <measurement group_id="O2" value="0.20" lower_limit="-1.1" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" lower_limit="-0.4" upper_limit="1.3"/>
                    <measurement group_id="O2" value="-0.10" lower_limit="-0.9" upper_limit="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.30" lower_limit="-0.4" upper_limit="1.2"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-0.8" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.55" lower_limit="-0.8" upper_limit="1.5"/>
                    <measurement group_id="O2" value="-0.10" lower_limit="-0.9" upper_limit="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" lower_limit="-0.7" upper_limit="1.5"/>
                    <measurement group_id="O2" value="-0.10" lower_limit="-1.2" upper_limit="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>54 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.25" lower_limit="-0.3" upper_limit="1.3"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-1.5" upper_limit="21.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" lower_limit="-1.0" upper_limit="1.4"/>
                    <measurement group_id="O2" value="-0.10" lower_limit="-1.8" upper_limit="19.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.20" lower_limit="-1.3" upper_limit="0.9"/>
                    <measurement group_id="O2" value="-0.10" lower_limit="-1.1" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>28 day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.60" lower_limit="-1.0" upper_limit="1.4"/>
                    <measurement group_id="O2" value="-0.10" lower_limit="-1.2" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ICU Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-2.30" lower_limit="-2.30" upper_limit="-2.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mortality -- TEAEs Leading to Death</title>
        <description>The incidence of treatment-emergent adverse event (TEAEs) leading to death is presented by treatment group.</description>
        <time_frame>up to day 28</time_frame>
        <population>Safety Population: all randomised patients (who received at least one dose of the study treatment if poractant alfa-treated).</population>
        <group_list>
          <group group_id="O1">
            <title>Control Cohort</title>
            <description>Patients receiving standard-of-care (SoC)</description>
          </group>
          <group group_id="O2">
            <title>Poractant Alfa Treated Cohort</title>
            <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
          </group>
        </group_list>
        <measure>
          <title>Mortality -- TEAEs Leading to Death</title>
          <description>The incidence of treatment-emergent adverse event (TEAEs) leading to death is presented by treatment group.</description>
          <population>Safety Population: all randomised patients (who received at least one dose of the study treatment if poractant alfa-treated).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From screening procedures (Day 0) to the end of the study (Day 28).</time_frame>
      <desc>Analysis of adverse events (AEs) was performed on TEAEs, defined as AEs that started at or after treatment start (for the poractant alfa group) or at or after randomisation (for the control group).&#xD;
Safety set (SAF) was used to evaluate AEs and serious AEs (SAEs). The SAF included all enrolled patients, except for one, who was randomised to receive poractant alfa was not treated. All patients included in the SAF were also included in the ITT.</desc>
      <group_list>
        <group group_id="E1">
          <title>Control Cohort</title>
          <description>Patients receiving standard-of-care (SoC)</description>
        </group>
        <group group_id="E2">
          <title>Poractant Alfa Treated Cohort</title>
          <description>Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Bicytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrioventricular block</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Right ventricular failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pneumatosis intestinalis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nosocomial infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Soft tissue injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral artery embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cerebral disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Impaired gastric emptying</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperpyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hyperthermia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Haemophagocytic lymphohistiocytosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Aspergillus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Bacterial sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Empyema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Enterococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pneumococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pneumonia klebsiella</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Proteus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urinary tract infection bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Refractoriness to platelet transfusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Neutrophil count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Decubitus ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Chiesi can publish and/or present any results of this study at scientific meetings, and to submit the clinical trial data to national and international Regulatory Authorities. Chiesi reserves the right to use such data for industrial purposes. Investigators will inform Chiesi before using the results of the study for publication or presentation, and agree to provide the Sponsor with a copy of the proposed presentation. Data from individual study sites must not be published separately.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Once the impact of the Covid 19 pandemic significantly declined and intubated patients with acute respiratory distress syndrome (ARDS) outcome became rare, the Sponsor considered it unfeasible to maintain efforts to recruit further patients into the study. Thus, due to low recruitment, the study was terminated early for non-safety reasons.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Clinical Trial Transparency</name_or_title>
      <organization>Chiesi Farmaceutici S.p.A.</organization>
      <phone>+ 39 0521 2791</phone>
      <email>clinicaltrials_info@chiesi.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04502433
org study id: CLI-050000-04
secondary id: 2020-002632-75
nct id: NCT04502433
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study was to evaluate the efficacy and safety of poractant alfa
      (Curosurf®), administered by endotracheal (ET) instillation in hospitalized adult patients
      diagnosed with SARS-COV-19 acute respiratory distress syndrome (ARDS).
This was a multicentre, open-label, randomized phase II proof-of-concept study.

      The efficacy and safety of poractant alfa was evaluated in terms of ventilatory free days
      during the 21 days after randomization, in adult patients diagnosed with ARDS due to
      SARS-COV-19 infection.

      Each patient randomized to the study treatment received 3 administrations of Curosurf ® with
      a 24 hours dosing interval. The assessment collection was up to Day 28, when the evaluation
      occurred at the Intensive Care Unit (ICU), or by phone call if the patient has already been
      discharged.

      Seventy patients were planned to be randomized in the study with a ratio 3:2 (i.e. 42
      patients in the poractant alfa arm and 28 in the control arm). The control arm population
      received Standard of Care (SoC). This study was conducted in United Kingdom (UK), United
      States of America (US), and Italy.

      Overall, 13 patients (Curosurf ® group) and 8 patients (control group) were randomised in the
      study. Due to low recruitment rate the study was terminated early for non-safety reasons.

      Curosurf® is a pulmonary surfactant of natural origin which, when delivered endotracheally
      (ET). Curosurf® is currently approved for marketing as treatment of premature neonates with
      RDS or at risk of Respiratory Distress Syndrome (RDS). Chiesi Farmaceutici S.p.A (Chiesi)
      conducted this study with its porcine-derived surfactant, Curosurf® (poractant alfa), to
      evaluate the efficacy and safety in ventilated adult patients who were critically unwell in
      intensive care with SARS-COV-19 ARDS.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Seventy patients will be randomized in the study with a ratio 3:2 (i.e. 42 patients in the poractant alfa arm and 28 in the control arm).
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Days Alive and Ventilator-free Days
time frame: up to 21 days
description: The number of days alive and ventilator-free days, defined as the number of days the patient is not receiving mechanical ventilation over the 21 days following randomisation.
Mechanical ventilation was defined as invasive and non-invasive. The patient was defined as free of mechanical ventilation after 12 hours from the suspension of either invasive and non-invasive ventilation. Patients who died or were mechanically ventilated longer than this period were assessed as zero ventilator-free days.
measure: Percentage of Patients Alive and Free of Respiratory Failure at Day 28
time frame: at Day 28
description: The percentage of patients alive and free of respiratory failure (i.e. without need for mechanical ventilation, extracorporeal membrane oxygenation (ECMO), non-invasive ventilation, or high-flow nasal cannula oxygen delivery) at Day 28.
measure: Number of Days Alive and Ventilator-Free at Day 28
time frame: at Day 28
description: The number of days alive and ventilator-free (i.e. free of any mechanical ventilation for at least 12 hours) at Day 28.
measure: Mortality at Day 21 and Day 28
time frame: at Day 21 and at Day 28
description: Mortality at Day 21 and Day 28 of the study by treatment group.
measure: Number of Days Alive and Free From Invasive Ventilation at Day 21 and Day 28
time frame: Day 21 and Day 28
description: The number of days alive and free from invasive ventilation at Day 21 and Day 28 is presented by treatment group.
measure: Number of Days Alive and Free From Non-Invasive Ventilation at Day 21 and Day 28
time frame: Day 21 and Day 28
description: The number of days alive and free from non-invasive ventilation at Day 21 and Day 28 is presented by treatment group.
measure: Percentage of Patients With Improvement in Severity Status at Day 28 or Discharge (Severity Score: Mild, Moderate, Severe, or Death)
time frame: Day 28 or Discharge, whichever comes first
description: The severity status of patients at baseline and at Day 28/Discharge and the percentage of patients with improvement in severity status (i.e. a decrease of at least 1 point in severity status) at Day 28/Discharge relative to baseline is presented.
Severity was assessed using a point score system: Severity score was defined as mild, moderate, severe (see below*), or death and was based on PaO2/FiO2 ratio and patient status at Day 28/Discharge and numerically rated from 1-4, respectively. An improvement in severity was defined as a decrease of at least 1 point between baseline and Day 28/Discharge.
At Day 28 the last follow up evaluation took place on the ICU if, still requiring critical care, or by phone call if the patient has been discharged from ICU by that time.
*Mild: 200 mmHg < PaO2/FiO2 ratio ≤300 mmHg; Moderate: 100 mmHg < PaO2/FiO2 ratio ≤200 mmHg; Severe: PaO2/FiO2 ratio ≤100 mmHg
measure: Change From Baseline in Arterial Partial Pressure of Oxygen / Fraction of Inspired Oxygen (PaO2/FiO2) Ratio at Each Timepoint
time frame: up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28
description: Change from baseline in PaO2/FiO2 ratio measured at each timepoint following administration of each dose in the treatment and control group.
The change was calculated from two time points as the value at the later time point minus the value at baseline.
Partial pressure of oxygen (PaO2) is the oxygen pressure in arterial blood. The fraction of inspired oxygen (FiO2) is the concentration of oxygen in the gas mixture.
The fraction of inspired oxygen (PaO2/FiO2) ratio is widely used in ICUs as an indicator of oxygenation status.
measure: Percentage of Patients Alive and With PaO2/FiO2 Ratio Improvement >20% Compared to Baseline at Each Timepoint
time frame: up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28
description: The percentages of patients in categories of PaO2/FiO2 ratio improvement compared to baseline (>20%) at all timepoints post-baseline are summarised by treatment group.
measure: Change From Baseline in Fraction of Inspired Oxygen (FiO2) at Each Timepoint
time frame: up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28
description: The FiO2 at baseline and at selected timepoints post-baseline was measured. Results are shown as changes from baseline, summarised by treatment group.
The change was calculated from two time points as the value at the later time point minus the value at baseline. The unit for the variable is percent (%) and what is reported is an absolute change.
measure: Length of ICU Stay (Days) at Day 28
time frame: up to 28 days
description: The length of ICU stay (days) at Day 28 is presented by treatment by treatment group. Patients who died or were mechanically ventilated longer than this period were assigned with 28 days.
measure: Percentage of Patients Alive and Out of Intensive Care Unit (ICU) at Day 28
time frame: Day 28
description: The percentage of patients alive and out of ICU at Day 28 is presented by treatment group.
measure: Delta Sequential Organ Failure Assessment (SOFA) Score and Sub-component Measure at Day 3 and Day 28
time frame: Day 3 and Day 28 or discharge -- whichever comes first
description: The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body. The SOFA score was used to determine the extent of organ failure at Day 3 and Day 28/Discharge with respect to a pre-randomisation assessment.
The total score was derived from six sub-scores system categories: respiratory, neurological, cardiovascular, hepatic, coagulation, and renal systems; respective sub-scores were calculated primarily considering PaO2/FiO2 ratio, Glasgow Coma Scale, mean arterial pressure (MAP) or requirement for vasopressor administration, bilirubin levels, platelet levels and creatinine levels or daily urine output.
A score of 0, 1, 2, 3, or 4) was assigned to each of the six system category. The total score ranged from 0 (min) to 24 (max) points. To be considered organ failure free, a patient had to have a score of 0.
measure: Percentage of Patients Alive and Free of Organ Failure (SOFA Score=0)
time frame: at day 28 or discharge -- whichever comes first
description: The percentage of patients alive and organ failure free (defined as SOFA score=0) at Day 28/Discharge is presented by treatment group.
The total score was derived from six sub-scores system categories: respiratory, neurological, cardiovascular, hepatic, coagulation, and renal systems; respective sub-scores were calculated primarily considering PaO2/FiO2 ratio, Glasgow Coma Scale, mean arterial pressure (MAP) or requirement for vasopressor administration, bilirubin levels, platelet levels and creatinine levels or daily urine output.
A score of 0, 1, 2, 3, or 4) was assigned to each of the six system category. The total score ranged from 0 (min) to 24 (max) points. To be considered organ failure free, a patient had to have a score of 0.
measure: Ventilatory Parameter: Tidal Volume -- Change From Baseline in Tidal Volume (mL/kg BW) at All Timepoints up to Day 3 (72 Hours) and at Day 28
time frame: up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28
description: Ventilatory parameter: Change from baseline in tidal volume (mL/kg BW) at all timepoints up to Day 3 (72 hours) and at Day 28.
The change was calculated from two time points as the value at the later time point minus the value at baseline.
Tidal volume is the amount of air that moves in or out of the lungs with each respiratory cycle.
measure: Ventilatory Parameter: Respiratory Rate -- Change From Baseline in Respiratory Rate (Breaths/Minute) at All Timepoints up to Day 3 (72 Hours) and at Day 28
time frame: up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28
description: Ventilatory parameter: Change from baseline in respiratory rate (breaths/minute) at all timepoints up to Day 3 (72 hours) and at Day 28.
The change was calculated from two time points as the value at the later time point minus the value at baseline.
Respiratory rate is the number of breaths taken per minute.
measure: Ventilatory Parameter: Dynamic Compliance -- Change From Baseline in Dynamic Compliance (mL/cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28
time frame: up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28
description: Ventilatory parameter: Change from baseline in dynamic compliance (mL/cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.
The change was calculated from two time points as the value at the later time point minus the value at baseline.
Dynamic compliance: is the continuous measurement of pulmonary compliance calculated at each point representing schematic changes during rhythmic breathing. Dynamic compliance monitors both elastic and airway resistance.
measure: Ventilatory Parameter: Static Compliance -- Change From Baseline in Static Compliance (mL/cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28
time frame: up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28
description: Ventilatory parameter: static compliance -- change from baseline in static compliance (mL/cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.
The change was calculated from two time points as the value at the later time point minus the value at baseline.
At each time point the number of patients that contributed with a result value is indicated for both study arms.
Static Compliance: represents pulmonary compliance at a given fixed volume when there is no airflow, and muscles are relaxed.
measure: Ventilatory Parameter: Positive End-Expiratory Pressure (PEEP) -- Change From Baseline in PEEP (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28
time frame: up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28
description: Ventilatory parameter: Positive End-Expiratory Pressure -- Change from baseline in PEEP (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.
The change was calculated from two time points as the value at the later time point minus the value at baseline.
At each time point the number of patients that contributed with a result value is indicated for both study arms.
Positive end-expiratory pressure (PEEP) is the positive pressure that will remain in the airways at the end of the respiratory cycle (end of exhalation) that is greater than the atmospheric pressure in mechanically ventilated patients.
measure: Ventilatory Parameter: Peak Inspiratory Pressure -- Change From Baseline in Peak Inspiratory Pressure (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28
time frame: up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28
description: Ventilatory parameter: Peak Inspiratory Pressure -- Change from baseline in peak inspiratory pressure (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.
The change was calculated from two time points as the value at the later time point minus the value at baseline.
At each time point the number of patients that contributed with a result value is indicated for both study arms.
Peak inspiratory pressure (PIP) is the highest level of pressure applied to the lungs during inhalation. In mechanical ventilation the number reflects a positive pressure in centimetres of water pressure (cmH2O).
measure: Ventilatory Parameter: Plateau Pressure -- Change From Baseline in Plateau Pressure (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28
time frame: up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28
description: Ventilatory parameter: Plateau Pressure -- Change from baseline in plateau pressure (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.
The change was calculated from two time points as the value at the later time point minus the value at baseline.
At each time point the number of patients that contributed with a result value is indicated for both study arms.
Plateau pressure is the pressure that is applied by the mechanical ventilator to the small airways and alveoli.
measure: Blood Gas Analysis Acid-base Balance Parameters: Change From Baseline in Blood Gas Analysis Acid-base Balance Parameters -- pH
time frame: up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28
description: Change from baseline in blood gas analysis acid-base balance parameters -- pH.
The change was calculated from two time points as the value at the later time point minus the value at baseline.
Arterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.
measure: Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Partial Pressure of Carbon Dioxide (pCO2)
time frame: up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28
description: Change from baseline in blood gas analysis acid-base balance parameter -- pCO2.
The change was calculated from two time points as the value at the later time point minus the value at baseline.
Arterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.
measure: Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Partial Pressure of Oxygen (pO2)
time frame: up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28
description: Change from baseline in blood gas analysis acid-base balance parameter -- pO2.
The change was calculated from two time points as the value at the later time point minus the value at baseline.
Arterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.
measure: Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Bicarbonate (HCO3)
time frame: up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28
description: Change from baseline in blood gas analysis acid-base balance parameter -- Bicarbonate (HCO3).
The change was calculated from two time points as the value at the later time point minus the value at baseline.
Measured at 6-12-24h after each poractant alfa administration up to 72 hours and at similar timepoints in the control group (6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation) and then every 24 hours till the patient is discharged from the ICU
measure: Change From Baseline in Blood Parameter -- Lactate
time frame: up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28
description: Change from baseline in blood parameter -- Lactate
The change was calculated from two time points as the value at the later time point minus the value at baseline.
At each time point the number of patients that contributed with a result value is indicated for both study arms.
Arterial blood lactate was measured at 6, 12, 24, 30, 36, 48, 54, 60, and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.
measure: Mortality -- TEAEs Leading to Death
time frame: up to day 28
description: The incidence of treatment-emergent adverse event (TEAEs) leading to death is presented by treatment group.
arm group label: Control
arm group type: No Intervention
description: Patients treated with standard-of-care (SoC), as control cohort
arm group label: Poractant alfa
arm group type: Experimental
description: Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)
intervention type: Drug
intervention name: CUROSURF® (poractant alfa)
description: Three administrations with a 24 hours dosing interval.
Each endotracheal (ET) administration 1, 2, and 3 consisted of poractant alfa bolus:
30mg /kg (Lean Body Weight-LBW) = 0.375ml /kg LBW, diluted with normal saline up to 2ml /kg LBW.
arm group label: Poractant alfa
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Clark Howard, Prof. /MD
role: Principal Investigator
affiliation: University College, London
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Italy
country: United Kingdom
country: United States
url: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002632-75/results
description: Study Record on EU Clinical Trials Register including results
responsible party type: Sponsor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Syndrome
mesh term: Poractant alfa
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Once the impact of the Covid 19 pandemic significantly declined and intubated patients with acute respiratory distress syndrome (ARDS) outcome became rare, the Sponsor considered it unfeasible to maintain efforts to recruit further patients into the study. Thus, due to low recruitment, the study was terminated early for non-safety reasons.
point of contact: 