Back to resultsIs Adipose Tissue a Reservoir for SARS-Cov2 Spread in Covid-19 Patients? (TA/SARS-Cov2)
Primary Purpose
Covid-19 Patients
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
biopsies of subcutaneous adipose tissue
Sponsored by
About this trial
This is an interventional other trial for Covid-19 Patients
Eligibility Criteria
Inclusion Criteria:
- Male or female ≥ 18 years old
- Patients testing positive for Covid19
- Patients affiliated to social security
- Signing of free and informed consent
Exclusion Criteria:
- Vulnerable persons (- minors,
- adults under guardianship or curatorship,
- pregnant women,
- persons deprived of their liberty,
- persons who do not master the French language)
Sites / Locations
- CHU de Nice
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients with Covid-19
Arm Description
Outcomes
Primary Outcome Measures
The presence of SARS-CoV2 in adipose tissue of Covid19 patients
RT-qPCR for SARS-Cov-2 from RNAs and by immunodetection
Secondary Outcome Measures
The expression of inflammatory cytokines in adipose tissue of Covid19 patients
RT-qPCR for IL6
The expression of inflammatory cytokines in adipose tissue of Covid19 patients
RT-qPCR for IL1
The expression of inflammatory cytokines in adipose tissue of Covid19 patients
RT-qPCR for TNFa
Full Information
NCT ID
NCT04427878
First Posted
June 10, 2020
Last Updated
June 11, 2020
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT04427878
Brief Title
Is Adipose Tissue a Reservoir for SARS-Cov2 Spread in Covid-19 Patients?
Acronym
TA/SARS-Cov2
Official Title
Is Adipose Tissue a Reservoir for SARS-Cov2 Spread?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
July 9, 2020 (Anticipated)
Study Completion Date
July 9, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19 Patients
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients with Covid-19
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
biopsies of subcutaneous adipose tissue
Intervention Description
Two 4mm punch biopsies of subcutaneous abdominal or thight adipose tissue
Primary Outcome Measure Information:
Title
The presence of SARS-CoV2 in adipose tissue of Covid19 patients
Description
RT-qPCR for SARS-Cov-2 from RNAs and by immunodetection
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
The expression of inflammatory cytokines in adipose tissue of Covid19 patients
Description
RT-qPCR for IL6
Time Frame
Day 0
Title
The expression of inflammatory cytokines in adipose tissue of Covid19 patients
Description
RT-qPCR for IL1
Time Frame
Day 0
Title
The expression of inflammatory cytokines in adipose tissue of Covid19 patients
Description
RT-qPCR for TNFa
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female ≥ 18 years old
Patients testing positive for Covid19
Patients affiliated to social security
Signing of free and informed consent
Exclusion Criteria:
Vulnerable persons (- minors,
adults under guardianship or curatorship,
pregnant women,
persons deprived of their liberty,
persons who do not master the French language)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanina OLIVERI, PM
Phone
0033 4 92 03 42 54
Email
oliveri.v@chu-nice.fr
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanina OLIVERI, PM
Email
oliveri.v@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Berengère Chignon-Sicard, PH
12. IPD Sharing Statement
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Is Adipose Tissue a Reservoir for SARS-Cov2 Spread in Covid-19 Patients?
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