NCT04639440

Brief Summary

Overweight or obese patients are particularly exposed to severe forms of COVID-19. Few data suggest that adipose tissue infected with SARS-CoV-2 could be involved in the onset of the cytokine storm seen in severe forms of COVID-19. The aim of this study is to determine the pathogenesis of SARS-CoV-2-infection of adipose tissue. In particular the investigators will study how this virus enters the adipocyte and how it modulates metabolism and inflammation in the adipose tissue. From these data, the investigators hope to determine at the adipose tissue level, original therapeutic targets to modulate the effects of SARS-CoV-2 at the systemic level.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

November 23, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2021

Completed
Last Updated

November 20, 2020

Status Verified

October 1, 2020

Enrollment Period

12 months

First QC Date

October 28, 2020

Last Update Submit

November 19, 2020

Conditions

Keywords

Adipose tissueCovid19SARS-CoV2

Outcome Measures

Primary Outcomes (1)

  • Comparison of the expression of ACE2 and TMPRSS2 in the subcutaneous and visceral adipose tissue of obese patients. Determination of cells expressing ACE2 and TMPRSS2 in whole human adipose tissue.

    Analysis of the expression of mRNA and ACE2 and TMPRSS2 proteins in the subcutaneous and visceral adipose tissue of normal weight and obese patients

    12 months

Secondary Outcomes (5)

  • Demonstration of entry and replication of SARS-CoV-2 in human adipose tissue

    12 months

  • Consequences of infection with SARS-CoV-2 on the metabolism and inflammatory state of adipose tissue.

    12 months

  • Consequences of infection with SARS-CoV-2 on the metabolism and inflammatory state of adipose tissue.

    12 months

  • Effect of SARS-CoV-2 infection of adipose tissue / adipocytes from thin and obese subjects on endoplasmic reticulum (ER) homeostasis.

    12 months

  • Target endoplasmic reticulum stress to reduce spread of SARS-CoV-2 from adipose tissue

    12 months

Study Arms (2)

Obese or overweight patients

Other: Adipose tissue

Patients without overweight

Other: Adipose tissue

Interventions

Adipose tissue sampling

Obese or overweight patientsPatients without overweight

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Obese and thin patients operated on for abdominal vascular surgery.

You may qualify if:

  • Age greater than or equal to 18 years
  • All patients who are obese or overweight (\> 25 kg/m2) or non-obese (\< or = 25 kg/m2) operated for abdominal vascular surgery
  • Beneficiary or entitled to a social security scheme (except AME)

You may not qualify if:

  • Pregnant or breastfeeding woman
  • Patient refusal
  • Patient deprived of liberty or subject to a legal protection measure (guardianship, curatorship)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Pitié Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Olivier BOURRON, Dr

    Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier BOURRON, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 20, 2020

Study Start

November 23, 2020

Primary Completion

November 22, 2021

Study Completion

November 23, 2021

Last Updated

November 20, 2020

Record last verified: 2020-10

Locations