<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/NCT04435223</url>
  </required_header>
  <id_info>
    <org_study_id>NGUYEN AOIc 2020</org_study_id>
    <nct_id>NCT04435223</nct_id>
  </id_info>
  <brief_title>Lipid Metabolism in COVID-19 Severe Pneumonia Compared With Severe Pneumonia Caused by Other Pathogen</brief_title>
  <acronym>COVIDOLIP</acronym>
  <official_title>Lipid Metabolism in COVID-19 Severe Pneumonia Compared With Severe Pneumonia Caused by Other Pathogen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</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>
      SARS-COV 2 infection might be responsible for sever pneumonia. Obesity seems to be a risk&#xD;
      factor for severe SARS-COV 2 pneumonia. Lipid metabolism alteration are described with both&#xD;
      obesity and sepsis. The aim of the present study was to describe association between lipid&#xD;
      metabolism, obesity, sepsis inflammation and clinical outcome in COVID-19 patient with severe&#xD;
      pneumonia compared with severe pneumonia caused by other pathogenes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 7, 2020</start_date>
  <completion_date type="Actual">May 7, 2020</completion_date>
  <primary_completion_date type="Actual">May 7, 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>Cholesterol concentration</measure>
    <time_frame>Within 48 hours following hospital admission</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>LDL cholesterol / HDL cholesterol/ Lipoprotein size and composition/ Non esterified Fatty acid/ Triglyceridemia/ CETP and PLTP activity/ apolipoprotein canceration/ lipid peroxidation/ Pro and anti inflammatory profile.</measure>
    <time_frame>Within 48 hours following hospital admission</time_frame>
    <description>Ventilator free days (28 days)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">62</enrollment>
  <condition>COVID-19 Severe Pneumonia</condition>
  <condition>Severe Pneumonia Due to Other Pathogene</condition>
  <arm_group>
    <arm_group_label>COVID-19 severe pneumonia</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Severe pneumonia due to other pathogene</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>biological assays in particular on the lipid metabolism</intervention_name>
    <description>bioassays carried out on samples already collected and conserved</description>
    <arm_group_label>COVID-19 severe pneumonia</arm_group_label>
    <arm_group_label>Severe pneumonia due to other pathogene</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patient with pneumopathy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  2 of the following criteria: Cough/ Dyspnea/ Spitting/ Thoracic pain/ Hyperthermia&#xD;
             (&gt;=38 °C) Hypothermia (&lt; 35°C) AND new radiologic pulmonary infiltrate&#xD;
&#xD;
          -  At admission or within 48 hours following hospital admission&#xD;
&#xD;
          -  With 2 qSOFA criteria: MAP =&lt; 100 mmHg, Respiratory Rate &gt;= 22, Glasgow score &lt; 15 OR&#xD;
             on mechanical ventilation OR under vasopressor&#xD;
&#xD;
          -  Age &gt; 18&#xD;
&#xD;
          -  affiliated to social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  immunodepression&#xD;
&#xD;
          -  Pathology known to cause severe lymphopenia&#xD;
&#xD;
          -  hospitalisation within 3 month before inclusion AND sepsis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chu Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</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/NCT04435223
org study id: NGUYEN AOIc 2020
nct id: NCT04435223
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
SARS-COV 2 infection might be responsible for sever pneumonia. Obesity seems to be a risk
      factor for severe SARS-COV 2 pneumonia. Lipid metabolism alteration are described with both
      obesity and sepsis. The aim of the present study was to describe association between lipid
      metabolism, obesity, sepsis inflammation and clinical outcome in COVID-19 patient with severe
      pneumonia compared with severe pneumonia caused by other pathogenes.
observational model: Cohort
time perspective: Prospective
measure: Cholesterol concentration
time frame: Within 48 hours following hospital admission
measure: LDL cholesterol / HDL cholesterol/ Lipoprotein size and composition/ Non esterified Fatty acid/ Triglyceridemia/ CETP and PLTP activity/ apolipoprotein canceration/ lipid peroxidation/ Pro and anti inflammatory profile.
time frame: Within 48 hours following hospital admission
description: Ventilator free days (28 days)
arm group label: COVID-19 severe pneumonia
arm group label: Severe pneumonia due to other pathogene
intervention type: Biological
intervention name: biological assays in particular on the lipid metabolism
description: bioassays carried out on samples already collected and conserved
arm group label: COVID-19 severe pneumonia
arm group label: Severe pneumonia due to other pathogene
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia