<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/NCT04445246</url>
  </required_header>
  <id_info>
    <org_study_id>MRC-05-026</org_study_id>
    <nct_id>NCT04445246</nct_id>
  </id_info>
  <brief_title>Inhaled Iloprost for Suspected COVID-19 Respiratory Failure</brief_title>
  <acronym>ILOCOVID</acronym>
  <official_title>Inhaled Iloprost for the Treatment of Suspected COVID-19 Respiratory Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hamad Medical Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hamad Medical Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute respiratory distress syndrome (ARDS) is a type of respiratory failure characterized by&#xD;
      the rapid onset of widespread inflammation in the lungs. ARDS is thought to be the main cause&#xD;
      of respiratory failure in COVID-19 patients. Research is still ongoing to further elucidate&#xD;
      the different ARDS subtypes that may exist in COVID-19. It is crucial to find new targets for&#xD;
      treatment and support of COVID-19 patients with respiratory failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators hypothesize that inhaled prostacyclins (Iloprost in this study) may improve&#xD;
      inflammation and oxygenation in suspected or confirmed COVID-19 patients with respiratory&#xD;
      failure.&#xD;
&#xD;
      Research participants: Suspected or confirmed COVID-19 patients presenting to the emergency&#xD;
      department (ED) of intensive care units (ICU) with Hypoxemic respiratory failure.&#xD;
&#xD;
      Intervention: Inhaled Iloprost (Tradename Ventavis by Actelion Pharmaceuticals US, Inc.)&#xD;
      three times daily for 5 days Methods: patients will be screened in ED and ICU for inclusion&#xD;
      and exclusion criteria and then consent will be obtained. The intervention will be started&#xD;
      within 48 hours of presentation. Baseline parameters on oxygenation, inflammatory markers,&#xD;
      hemodynamics will be obtained and followed serially over the period of the intervention.&#xD;
      Additional data about time to intubation, time on mechanical ventilation, lung mechanics, and&#xD;
      need for prone positioning will also be collected.&#xD;
&#xD;
      Data will be analyzed for percentage improvement in oxygenation (Oxygen saturation and&#xD;
      PaO2/FiO2 ratio), trends of inflammatory markers, and hemodynamic stability while Iloprost is&#xD;
      administered.&#xD;
&#xD;
      Based on previous studies of Iloprost on ARDS patients, the investigators anticipate an&#xD;
      improvement in oxygenation and inflammatory parameters and possible prevention of intubation&#xD;
      with shorter mechanical ventilation times. Iloprost showed a safe profile with stable&#xD;
      hemodynamics during administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 23, 2020</start_date>
  <completion_date type="Actual">May 31, 2021</completion_date>
  <primary_completion_date type="Actual">May 31, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in oxygenation parameters</measure>
    <time_frame>5 days</time_frame>
    <description>change in oxygen saturation and PaO2/FiO2 ratio by 20% on day 6 compared to baseline values prior to Iloprost initiation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rates of endotracheal intubation</measure>
    <time_frame>28 days</time_frame>
    <description>likelihood to require intubation in the cohort treated with Iloprost</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Invasive ventilation duration</measure>
    <time_frame>28 days</time_frame>
    <description>in days in the cohort treated with Iloprost</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>28 days</time_frame>
    <description>in days in the cohort treated with Iloprost</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Length of stay</measure>
    <time_frame>28 days</time_frame>
    <description>in days in the cohort treated with Iloprost</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of proning therapy</measure>
    <time_frame>28 days</time_frame>
    <description>likelihood to require proning in the cohort treated with Iloprost</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of ECMO cannulation</measure>
    <time_frame>28 days</time_frame>
    <description>likelihood to require ECMO cannulation in the cohort treated with Iloprost</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>28 days</time_frame>
    <description>likelihood to die of any cause within 28 days of initial hospital presentation</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>COVID-19</condition>
  <condition>ARDS, Human</condition>
  <condition>Hypoxemic Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>Inhaled Iloprost therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Inhaled ILOPROST</intervention_name>
    <description>Inhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization.</description>
    <arm_group_label>Inhaled Iloprost therapy</arm_group_label>
    <other_name>Ventavis by Actelion Pharmaceuticals US, Inc.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Suspected or confirmed COVID-19 patient by PCR&#xD;
&#xD;
          2. O2 saturation =&lt;92% on 5 or more l/min of O2 by NC or Face mask&#xD;
&#xD;
          3. On CPAP, HFNC or Invasive ventilation&#xD;
&#xD;
          4. Enrollment within 48h of onset of hypoxemia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age &lt;18&#xD;
&#xD;
          2. Pregnancy or Positive pregnancy test at the time of screening&#xD;
&#xD;
          3. Clinical evidence of left atrial hypertension or known chronic CHF&#xD;
&#xD;
          4. Persistent Hypotension SBP&lt;85 on presentation&#xD;
&#xD;
          5. Mechanical ventilation &gt;7 days&#xD;
&#xD;
          6. Patients who received iloprost treatment for any indication within 48 hours prior to&#xD;
             enrollment in the clinical trial or patients who were on thrombin inhibitors, or&#xD;
             nitric oxide within the previous 24 h before study randomization are also excluded.&#xD;
&#xD;
          7. Patients with contraindication for ilioprost&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nadir Kharma, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hamad Medical Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hamad Medical Corporation</name>
      <address>
        <city>Doha</city>
        <country>Qatar</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Qatar</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>March 26, 2022</last_update_submitted>
  <last_update_submitted_qc>March 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Iloprost</keyword>
  <keyword>prostacyclins</keyword>
  <keyword>inhaled nitric oxide</keyword>
  <keyword>pulmonary vasodilators</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iloprost</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04445246
org study id: MRC-05-026
nct id: NCT04445246
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Acute respiratory distress syndrome (ARDS) is a type of respiratory failure characterized by
      the rapid onset of widespread inflammation in the lungs. ARDS is thought to be the main cause
      of respiratory failure in COVID-19 patients. Research is still ongoing to further elucidate
      the different ARDS subtypes that may exist in COVID-19. It is crucial to find new targets for
      treatment and support of COVID-19 patients with respiratory failure.
The investigators hypothesize that inhaled prostacyclins (Iloprost in this study) may improve
      inflammation and oxygenation in suspected or confirmed COVID-19 patients with respiratory
      failure.

      Research participants: Suspected or confirmed COVID-19 patients presenting to the emergency
      department (ED) of intensive care units (ICU) with Hypoxemic respiratory failure.

      Intervention: Inhaled Iloprost (Tradename Ventavis by Actelion Pharmaceuticals US, Inc.)
      three times daily for 5 days Methods: patients will be screened in ED and ICU for inclusion
      and exclusion criteria and then consent will be obtained. The intervention will be started
      within 48 hours of presentation. Baseline parameters on oxygenation, inflammatory markers,
      hemodynamics will be obtained and followed serially over the period of the intervention.
      Additional data about time to intubation, time on mechanical ventilation, lung mechanics, and
      need for prone positioning will also be collected.

      Data will be analyzed for percentage improvement in oxygenation (Oxygen saturation and
      PaO2/FiO2 ratio), trends of inflammatory markers, and hemodynamic stability while Iloprost is
      administered.

      Based on previous studies of Iloprost on ARDS patients, the investigators anticipate an
      improvement in oxygenation and inflammatory parameters and possible prevention of intubation
      with shorter mechanical ventilation times. Iloprost showed a safe profile with stable
      hemodynamics during administration.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change in oxygenation parameters
time frame: 5 days
description: change in oxygen saturation and PaO2/FiO2 ratio by 20% on day 6 compared to baseline values prior to Iloprost initiation.
measure: Rates of endotracheal intubation
time frame: 28 days
description: likelihood to require intubation in the cohort treated with Iloprost
measure: Invasive ventilation duration
time frame: 28 days
description: in days in the cohort treated with Iloprost
measure: ICU length of stay
time frame: 28 days
description: in days in the cohort treated with Iloprost
measure: Hospital Length of stay
time frame: 28 days
description: in days in the cohort treated with Iloprost
measure: Rates of proning therapy
time frame: 28 days
description: likelihood to require proning in the cohort treated with Iloprost
measure: Rates of ECMO cannulation
time frame: 28 days
description: likelihood to require ECMO cannulation in the cohort treated with Iloprost
measure: Mortality
time frame: 28 days
description: likelihood to die of any cause within 28 days of initial hospital presentation
arm group label: Inhaled Iloprost therapy
arm group type: Experimental
description: Inhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization
intervention type: Drug
intervention name: Inhaled ILOPROST
description: Inhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization.
arm group label: Inhaled Iloprost therapy
other name: Ventavis by Actelion Pharmaceuticals US, Inc.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nadir Kharma, MD
role: Principal Investigator
affiliation: Hamad Medical Corporation
facility: 
country: Qatar
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Respiratory Insufficiency
mesh term: Respiratory Distress Syndrome
mesh term: Iloprost