Impact of Adipose Tissue in COVID-19

Covid19 Clinical Trial

— COVIFAT  

Official title:

Impact of Adipose Tissue in COVID-19 : From Pathophysiology to Therapeutic Perspectives

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04639440
• Other study ID #: APHP200983
• Secondary ID: 2020-A02403-36
• Status: Not yet recruiting
• Start date: November 23, 2020
• Est. completion date: November 23, 2021

Study information

• Verified date: October 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Olivier BOURRON, Dr
• Phone: 0142178118
• Email: olivier.bourron[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 23, 2021
• Est. primary completion date: November 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Covid19

Intervention

Other:
• Adipose tissue
Adipose tissue sampling

Locations

Country	Name	City	State
France	Hôpital de la Pitié Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Demonstration of entry and replication of SARS-CoV-2 in human adipose tissue	Infection of human adipocytes in lean and obese subjects by SARS-CoV-2	12 months
Secondary	Consequences of infection with SARS-CoV-2 on the metabolism and inflammatory state of adipose tissue.	Assessment of the expression and secretion of inflammatory cytokines (TNF-a, IL-1 , IL-4 , IL-6 , IL-7 , IL-10 , IL-12 , IL-13 , IL-18 ¸ IL-23, INF-a, INF-ß) after infection with SARS-CoV-2 of adipose tissue / adipocytes of thin and obese subjects.; Evaluation of SARS-CoV-2 infection on the lipolysis of adipose tissue / adipocytes in thin and obese subjects.	12 months
Secondary	Consequences of infection with SARS-CoV-2 on the metabolism and inflammatory state of adipose tissue.	Evaluation of SARS-CoV-2 infection on the lipolysis of adipose tissue / adipocytes in thin and obese subjects.	12 months
Secondary	Effect of SARS-CoV-2 infection of adipose tissue / adipocytes from thin and obese subjects on endoplasmic reticulum (ER) homeostasis.	Study whether infection with SARS-CoV-2 activates the RE stress pathways in adipose tissue	12 months
Secondary	Target endoplasmic reticulum stress to reduce spread of SARS-CoV-2 from adipose tissue	Use of RE stress inhibitors on adipocytes infected with SARS-CoV-2 and assess their effect on the maturation of the virus in infected cells.	12 months