<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/NCT04487769</url>
  </required_header>
  <id_info>
    <org_study_id>LUS-COVID</org_study_id>
    <nct_id>NCT04487769</nct_id>
  </id_info>
  <brief_title>Lung Ultrasound in COVID-19 Patients</brief_title>
  <acronym>LUS-COVID</acronym>
  <official_title>Early Lung Ultrasound Score Predicts Duration of Ventilation and ICU Mortality in COVID-19 Invasively Ventilated Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre Hospitalier Universitaire de Brussels, Brussels, Belgium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Miulli Regional Hospital, Acquaviva delle Fonti, Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Foggia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Bari Aldo Moro</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the prognostic performance of an early global LUS score with respect to the&#xD;
      mortality in ICU and duration of ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an international multicenter cohort study on data collected between March and April&#xD;
      2020. The first available lung ultrasound examination that used a 12-regions approach was&#xD;
      used to calculate the global LUS score.&#xD;
&#xD;
      Patients are included if they fulfilled the following criteria: 1) admitted to one of the&#xD;
      participating ICU; 2) for invasive ventilation; 3) for respiratory failure due to confirmed&#xD;
      COVID-19; and 4) having had a LUS examination performed within the first week of start of&#xD;
      invasive ventilation.&#xD;
&#xD;
      The primary and secondary outcomes were liberation from invasive ventilation and mortality.&#xD;
&#xD;
      Demographic, clinical and outcome variables will be presented as percentages for categorical&#xD;
      variables and as medians with interquartile ranges (IQR) for continuous variables.&#xD;
&#xD;
      Receiver operating characteristics (ROC) analysis will be used to derive the prognostic&#xD;
      discriminatory performance of global LUS score in determining succesful extubation and&#xD;
      mortality at day 28. The Youden index will be used to derive the optimal cut-off. The&#xD;
      association of global LUS with unfavourable outcomes are analyzed with Cox proportional&#xD;
      hazard analysis (for successful extubation and alive at day 28), logistic regression models&#xD;
      (mortality at day 28). Hazard ratio or odds ratio with 95% confidence intervals were&#xD;
      calculated for each outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">October 2024</completion_date>
  <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Liberation from invasive ventilation</measure>
    <time_frame>28 days</time_frame>
    <description>Patient who survived but remained invasively ventilated up to day 28 were marked without event. Patients who survived but were extubated were marked with an event at the day of successful extubation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>28 days</time_frame>
    <description>Patient who survived up to day 28 were marked without event. Patients who survived but were extubated were marked with an event at the day of successful extubation.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Covid19</condition>
  <condition>Ultrasound</condition>
  <condition>ARDS</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Severe COVID-19 infection under invasive ventilation who received lung ultrasound&#xD;
        examination as a standard care.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admitted to an ICU participating in this study between February 1, 2020 and April 30,&#xD;
             2020&#xD;
&#xD;
          -  Confirmed with reverse transcriptase polymerase chain reaction (RT-PCR) COVID-19&#xD;
             infection&#xD;
&#xD;
          -  Having had received invasive ventilation&#xD;
&#xD;
          -  Having had examined at least once with lung ultrasound under invasive ventilation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  First examination with LUS in patients already under extracorporeal membrane&#xD;
             oxygenation (ECMO) support.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Marcus J Schultz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Amsterdam University Medical Centers, location 'AMC'</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Charalampos Pierrakos, MD</last_name>
    <phone>+3224772111</phone>
    <email>charalampos.pierrakos@chu-brugmann.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Luigi Pisani, MD</last_name>
    <email>luigipisani@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marcus J Schultz, MD PhD</last_name>
      <email>marcus.j.schultz@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Lieuwe D Bos, MD PhD</last_name>
      <email>l.d.bos@amsterdamumc.nl</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Marcus J. Schultz</investigator_full_name>
    <investigator_title>Prof. M.J. Schultz, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>new coronavirus disease</keyword>
  <keyword>coronavirus disease 2019</keyword>
  <keyword>lung imaging</keyword>
  <keyword>lung ultrasound</keyword>
  <keyword>lung ultrasound score</keyword>
  <keyword>prognostication</keyword>
  <keyword>duration of ventilation</keyword>
  <keyword>mortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04487769
org study id: LUS-COVID
nct id: NCT04487769
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
To assess the prognostic performance of an early global LUS score with respect to the
      mortality in ICU and duration of ventilation.
This is an international multicenter cohort study on data collected between March and April
      2020. The first available lung ultrasound examination that used a 12-regions approach was
      used to calculate the global LUS score.

      Patients are included if they fulfilled the following criteria: 1) admitted to one of the
      participating ICU; 2) for invasive ventilation; 3) for respiratory failure due to confirmed
      COVID-19; and 4) having had a LUS examination performed within the first week of start of
      invasive ventilation.

      The primary and secondary outcomes were liberation from invasive ventilation and mortality.

      Demographic, clinical and outcome variables will be presented as percentages for categorical
      variables and as medians with interquartile ranges (IQR) for continuous variables.

      Receiver operating characteristics (ROC) analysis will be used to derive the prognostic
      discriminatory performance of global LUS score in determining succesful extubation and
      mortality at day 28. The Youden index will be used to derive the optimal cut-off. The
      association of global LUS with unfavourable outcomes are analyzed with Cox proportional
      hazard analysis (for successful extubation and alive at day 28), logistic regression models
      (mortality at day 28). Hazard ratio or odds ratio with 95% confidence intervals were
      calculated for each outcome.
observational model: Cohort
time perspective: Retrospective
measure: Liberation from invasive ventilation
time frame: 28 days
description: Patient who survived but remained invasively ventilated up to day 28 were marked without event. Patients who survived but were extubated were marked with an event at the day of successful extubation.
measure: Mortality
time frame: 28 days
description: Patient who survived up to day 28 were marked without event. Patients who survived but were extubated were marked with an event at the day of successful extubation.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Marcus J Schultz, MD
role: Principal Investigator
affiliation: Amsterdam University Medical Centers, location 'AMC'
last name: Charalampos Pierrakos, MD
phone: +3224772111
email: charalampos.pierrakos@chu-brugmann.be
last name: Luigi Pisani, MD
email: luigipisani@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: Prof. Dr. Marcus J. Schultz
investigator title: Prof. M.J. Schultz, MD, PhD
mesh term: COVID-19
sharing ipd: Undecided