<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/NCT04425213</url>
  </required_header>
  <id_info>
    <org_study_id>2020PI082</org_study_id>
    <nct_id>NCT04425213</nct_id>
  </id_info>
  <brief_title>Obesity and Mortality of Critically Ill Patients With COVID-19</brief_title>
  <acronym>COV-OB-ICU</acronym>
  <official_title>Obesity as a Risk Factor for Mortality of Critically Ill Patients With Coronavirus Disease 2019 (COVID-19): a Cohort Study of the First Wave in Nancy, France</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Disproportionate impact of COVID-19 in patients with obesity is now well established.&#xD;
&#xD;
      Obesity is associated with severe forms of COVID-19 and may be a risk factor of intensive&#xD;
      care unit (ICU) admission. Obesity is associated with COVID-19 related hospital death in a&#xD;
      large United Kingdom cohort study. However, there is a gap of knowledge on assessment of&#xD;
      outcomes such as severity of Acute Respiratory Distress syndrome (ARDS), duration of&#xD;
      hospitalisation and mortality in ICU. Moreover, an obesity survival paradox has been observed&#xD;
      in patients with ARDS. This raises the question whether the obesity paradox has been broken&#xD;
      by COVID-19.&#xD;
&#xD;
      The investigators aim to explore risk factors of in-ICU death for patient with COVID-19,&#xD;
      including obesity and other chronic diseases and to describe the clinical course and&#xD;
      outcomes, including the management of acute respiratory failure and other intensive care&#xD;
      management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators aim to report ICU mortality for patients according to BMI category and to&#xD;
      describe the detailed ICU clinical course of illness :&#xD;
&#xD;
        -  Risk factors for ICU mortality : age, sex, baseline comorbidities&#xD;
&#xD;
        -  Causes of death&#xD;
&#xD;
        -  Risk factors for use of non invasive mechanical ventilation&#xD;
&#xD;
        -  Non-fatal outcomes&#xD;
&#xD;
        -  Ventilator-free days&#xD;
&#xD;
        -  ICU length of stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 12, 2020</start_date>
  <completion_date type="Actual">May 26, 2020</completion_date>
  <primary_completion_date type="Actual">May 25, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>ICU mortality</measure>
    <time_frame>through study completion, an average of 14 days</time_frame>
    <description>number of fatal cases</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Invasive mechanical ventilation</measure>
    <time_frame>through study completion, an average of 14 days</time_frame>
    <description>number of patients with invasive mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-hospital mortality</measure>
    <time_frame>through study completion, an average of 21 days</time_frame>
    <description>number of fatal cases</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">250</enrollment>
  <condition>COVID</condition>
  <condition>Severe Acute Respiratory Syndrome</condition>
  <condition>Obesity</condition>
  <condition>Comorbidities and Coexisting Conditions</condition>
  <arm_group>
    <arm_group_label>Normal weight</arm_group_label>
    <description>BMI &lt; 25 kg/m2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Overweight</arm_group_label>
    <description>BMI : 25 - 29.9 kg/m2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate obesity</arm_group_label>
    <description>BMI : 30 - 39.9 kg/m2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Severe obesity</arm_group_label>
    <description>BMI : &gt; or = 40 kg/m2</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Critically ill patients admitted to ICUs of the University Hospital during the first Covid&#xD;
        -19 wave in Nancy, Région Grand Est, France&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients with COVID-19 pneumonia admitted to ICUs between February 27th and&#xD;
             April 18th 2020.&#xD;
&#xD;
          -  Infection confirmed by reverse transcriptase polymerase chain reaction assay or&#xD;
             radiologically by chest computed tomography scan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No weight or height measurement available in the medical files&#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>Olivier Ziegler, PU-PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHRU of Nancy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre hospitalo-universitaire régional de Nancy</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mortality</keyword>
  <keyword>Covid-19</keyword>
  <keyword>Invasive mechanical ventilation</keyword>
  <keyword>Obesity</keyword>
  <keyword>Acute Respiratory Distress syndrome</keyword>
  <keyword>Intensive Care Unit</keyword>
  <keyword>Critically ill patient</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Severe Acute Respiratory Syndrome</mesh_term>
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_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/NCT04425213
org study id: 2020PI082
nct id: NCT04425213
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Disproportionate impact of COVID-19 in patients with obesity is now well established.

      Obesity is associated with severe forms of COVID-19 and may be a risk factor of intensive
      care unit (ICU) admission. Obesity is associated with COVID-19 related hospital death in a
      large United Kingdom cohort study. However, there is a gap of knowledge on assessment of
      outcomes such as severity of Acute Respiratory Distress syndrome (ARDS), duration of
      hospitalisation and mortality in ICU. Moreover, an obesity survival paradox has been observed
      in patients with ARDS. This raises the question whether the obesity paradox has been broken
      by COVID-19.

      The investigators aim to explore risk factors of in-ICU death for patient with COVID-19,
      including obesity and other chronic diseases and to describe the clinical course and
      outcomes, including the management of acute respiratory failure and other intensive care
      management.
The investigators aim to report ICU mortality for patients according to BMI category and to
      describe the detailed ICU clinical course of illness :

        -  Risk factors for ICU mortality : age, sex, baseline comorbidities

        -  Causes of death

        -  Risk factors for use of non invasive mechanical ventilation

        -  Non-fatal outcomes

        -  Ventilator-free days

        -  ICU length of stay.
observational model: Cohort
time perspective: Prospective
measure: ICU mortality
time frame: through study completion, an average of 14 days
description: number of fatal cases
measure: Invasive mechanical ventilation
time frame: through study completion, an average of 14 days
description: number of patients with invasive mechanical ventilation
measure: In-hospital mortality
time frame: through study completion, an average of 21 days
description: number of fatal cases
arm group label: Normal weight
description: BMI < 25 kg/m2
arm group label: Overweight
description: BMI : 25 - 29.9 kg/m2
arm group label: Moderate obesity
description: BMI : 30 - 39.9 kg/m2
arm group label: Severe obesity
description: BMI : > or = 40 kg/m2
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Olivier Ziegler, PU-PH
role: Principal Investigator
affiliation: CHRU of Nancy
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Severe Acute Respiratory Syndrome
mesh term: Obesity
mesh term: Critical Illness