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Impact of Adipose Tissue in COVID-19 (COVIFAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04639440
Recruitment Status : Not yet recruiting
First Posted : November 20, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.

Condition or disease Intervention/treatment
Covid19 Other: Adipose tissue

Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Impact of Adipose Tissue in COVID-19 : From Pathophysiology to Therapeutic Perspectives
Estimated Study Start Date : November 23, 2020
Estimated Primary Completion Date : November 22, 2021
Estimated Study Completion Date : November 23, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Obese or overweight patients Other: Adipose tissue
Adipose tissue sampling
Patients without overweight Other: Adipose tissue
Adipose tissue sampling


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 12 months ]
    Analysis of the expression of mRNA and ACE2 and TMPRSS2 proteins in the subcutaneous and visceral adipose tissue of normal weight and obese patients


Secondary Outcome Measures :
  1. Demonstration of entry and replication of SARS-CoV-2 in human adipose tissue [ Time Frame: 12 months ]
    Infection of human adipocytes in lean and obese subjects by SARS-CoV-2

  2. Consequences of infection with SARS-CoV-2 on the metabolism and inflammatory state of adipose tissue. [ Time Frame: 12 months ]

    Assessment of the expression and secretion of inflammatory cytokines (TNF-α, IL-1 , IL-4 , IL-6 , IL-7 , IL-10 , IL-12 , IL-13 , IL-18 ¸ IL-23, INF-α, INF-β) 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.


  3. Consequences of infection with SARS-CoV-2 on the metabolism and inflammatory state of adipose tissue. [ Time Frame: 12 months ]
    Evaluation of SARS-CoV-2 infection on the lipolysis of adipose tissue / adipocytes in thin and obese subjects.

  4. Effect of SARS-CoV-2 infection of adipose tissue / adipocytes from thin and obese subjects on endoplasmic reticulum (ER) homeostasis. [ Time Frame: 12 months ]
    Study whether infection with SARS-CoV-2 activates the RE stress pathways in adipose tissue

  5. Target endoplasmic reticulum stress to reduce spread of SARS-CoV-2 from adipose tissue [ Time Frame: 12 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Obese and thin patients operated on for abdominal vascular surgery.
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04639440


Contacts
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Contact: Olivier BOURRON, Dr 0142178118 olivier.bourron@aphp.fr

Locations
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France
Hôpital de la Pitié Salpêtrière
Paris, France, 75013
Contact: Olivier BOURRON, Dr    01 42 17 81 18    olivier.bourron@aphp.fr   
Contact: Fabienne FOUFELLE, Dr    01 42 34 69 23    fabienne.foufelle@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Olivier BOURRON, Dr Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04639440    
Other Study ID Numbers: APHP200983
2020-A02403-36 ( Other Identifier: ANSM )
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Adipose tissue
Covid19
SARS-CoV2
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases