<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/NCT04427878</url>
  </required_header>
  <id_info>
    <org_study_id>20-PP-15</org_study_id>
    <nct_id>NCT04427878</nct_id>
  </id_info>
  <brief_title>Is Adipose Tissue a Reservoir for SARS-Cov2 Spread in Covid-19 Patients?</brief_title>
  <acronym>TA/SARS-Cov2</acronym>
  <official_title>Is Adipose Tissue a Reservoir for SARS-Cov2 Spread?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</source>
  <oversight_info>
    <has_dmc>No</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>
      Resident cells of human adipose tissue express ACE2 and DPP4, receptors for SARS-Cov2. The&#xD;
      hypothesis is that the virus may enter and spread in fat depots.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">July 9, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 9, 2020</primary_completion_date>
  <phase>N/A</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The presence of SARS-CoV2 in adipose tissue of Covid19 patients</measure>
    <time_frame>Day 0</time_frame>
    <description>RT-qPCR for SARS-Cov-2 from RNAs and by immunodetection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The expression of inflammatory cytokines in adipose tissue of Covid19 patients</measure>
    <time_frame>Day 0</time_frame>
    <description>RT-qPCR for IL6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The expression of inflammatory cytokines in adipose tissue of Covid19 patients</measure>
    <time_frame>Day 0</time_frame>
    <description>RT-qPCR for IL1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The expression of inflammatory cytokines in adipose tissue of Covid19 patients</measure>
    <time_frame>Day 0</time_frame>
    <description>RT-qPCR for TNFa</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">5</enrollment>
  <condition>Covid-19 Patients</condition>
  <arm_group>
    <arm_group_label>patients with Covid-19</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>biopsies of subcutaneous adipose tissue</intervention_name>
    <description>Two 4mm punch biopsies of subcutaneous abdominal or thight adipose tissue</description>
    <arm_group_label>patients with Covid-19</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female ≥ 18 years old&#xD;
&#xD;
          -  Patients testing positive for Covid19&#xD;
&#xD;
          -  Patients affiliated to social security&#xD;
&#xD;
          -  Signing of free and informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vulnerable persons (- minors,&#xD;
&#xD;
          -  adults under guardianship or curatorship,&#xD;
&#xD;
          -  pregnant women,&#xD;
&#xD;
          -  persons deprived of their liberty,&#xD;
&#xD;
          -  persons who do not master the French language)&#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_contact>
    <last_name>Vanina OLIVERI, PM</last_name>
    <phone>0033 4 92 03 42 54</phone>
    <email>oliveri.v@chu-nice.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Nice</name>
      <address>
        <city>Nice</city>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Vanina OLIVERI, PM</last_name>
      <email>oliveri.v@chu-nice.fr</email>
    </contact>
    <investigator>
      <last_name>Berengère Chignon-Sicard, PH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 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 11, 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>
  </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/NCT04427878
org study id: 20-PP-15
nct id: NCT04427878
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Resident cells of human adipose tissue express ACE2 and DPP4, receptors for SARS-Cov2. The
      hypothesis is that the virus may enter and spread in fat depots.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: The presence of SARS-CoV2 in adipose tissue of Covid19 patients
time frame: Day 0
description: RT-qPCR for SARS-Cov-2 from RNAs and by immunodetection
measure: The expression of inflammatory cytokines in adipose tissue of Covid19 patients
time frame: Day 0
description: RT-qPCR for IL6
measure: The expression of inflammatory cytokines in adipose tissue of Covid19 patients
time frame: Day 0
description: RT-qPCR for IL1
measure: The expression of inflammatory cytokines in adipose tissue of Covid19 patients
time frame: Day 0
description: RT-qPCR for TNFa
arm group label: patients with Covid-19
arm group type: Experimental
intervention type: Procedure
intervention name: biopsies of subcutaneous adipose tissue
description: Two 4mm punch biopsies of subcutaneous abdominal or thight adipose tissue
arm group label: patients with Covid-19
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vanina OLIVERI, PM
phone: 0033 4 92 03 42 54
email: oliveri.v@chu-nice.fr
facility: 
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: COVID-19