<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/NCT04485338</url>
  </required_header>
  <id_info>
    <org_study_id>RALE-COVID</org_study_id>
    <nct_id>NCT04485338</nct_id>
  </id_info>
  <brief_title>Chest Radiography in COVID-19 Patients</brief_title>
  <official_title>Radiographic Assessment of Lung Edema in Invasively Ventilated COVID-19 Patients (RALE-COVID) - Protocol for an International Multicenter Retrospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Bari Aldo Moro</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universitair Ziekenhuis Brussel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chonburi Hospital</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 the RALE score with respect to duration of&#xD;
      ventilation, and to describe changes in the RALE score over time.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">September 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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>The prognostic capacity of the Radiographic Assessment of Lung Edema (RALE) score of the first CXR under invasive ventilation in patients with severe COVID-19.</measure>
    <time_frame>90 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The prognostic capacity of changes in the RALE score of consecutive CXRs under invasive ventilation in patients with severe COVID-19</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ventilator-free day and alive at day 28 (VFD)</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">139</enrollment>
  <condition>Covid19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Severe COVID-19 patients under invasive ventilation who received as part of standard care&#xD;
        and routine imaging.&#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 December 1, 2019 and May 31,&#xD;
             2020&#xD;
&#xD;
          -  Having had received invasive ventilation&#xD;
&#xD;
          -  Having had received at least one chest radiograph under invasive ventilation&#xD;
&#xD;
          -  Confirmed novel coronavirus diseases (COVID-19)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Age &lt; 18 years&#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, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Amsterdam University Medical Centers, location 'AMC'</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Amsterdam UMC location AMC</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>February 15, 2022</last_update_submitted>
  <last_update_submitted_qc>February 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2022</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>Chest radiography</keyword>
  <keyword>RALEscore</keyword>
  <keyword>Radiographic Assessment of Lung Edema</keyword>
  <keyword>ICU</keyword>
  <keyword>invasively ventilated</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/NCT04485338
org study id: RALE-COVID
nct id: NCT04485338
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
To assess the prognostic performance of the RALE score with respect to duration of
      ventilation, and to describe changes in the RALE score over time.
observational model: Cohort
time perspective: Retrospective
measure: The prognostic capacity of the Radiographic Assessment of Lung Edema (RALE) score of the first CXR under invasive ventilation in patients with severe COVID-19.
time frame: 90 days
measure: The prognostic capacity of changes in the RALE score of consecutive CXRs under invasive ventilation in patients with severe COVID-19
time frame: 90 days
measure: Number of ventilator-free day and alive at day 28 (VFD)
time frame: 28 days
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Marcus J. Schultz, Prof.
role: Principal Investigator
affiliation: Amsterdam University Medical Centers, location 'AMC'
facility: 
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