Covid19COVIFATNCT04639440
Impact of Adipose Tissue in COVID-19
An observational study of Covid19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Adipose tissue
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2020to 23 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese and thin patients operated on for abdominal vascular surgery.
Who may be able to join
- 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)
Who cannot join
- Pregnant or breastfeeding woman
- Patient refusal
- Patient deprived of liberty or subject to a legal protection measure (guardianship, curatorship)
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital de la Pitié Salpêtrière
Paris, 75013
Olivier BOURRON, Dr, 01 42 17 81 18, olivier.bourron@aphp.fr
Fabienne FOUFELLE, Dr, 01 42 34 69 23, fabienne.foufelle@aphp.fr
About this study
Official title: Impact of Adipose Tissue in COVID-19 : From Pathophysiology to Therapeutic Perspectives
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.
- Conditions
- Covid19
- Being tested
- Adipose tissue
- Keywords
- Adipose tissue, Covid19, SARS-CoV2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose tissueOther
Adipose tissue sampling
| Study group | Role | What they receive |
|---|---|---|
| Obese or overweight patients | Not described Receives: Other: Adipose tissue | |
| Patients without overweight | Not described Receives: Other: Adipose tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (5)
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
Measured: 12 months
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-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.
Measured: 12 months
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.
Measured: 12 months
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
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start23 Nov 2020 (estimated)
- Primary completion22 Nov 2021 (estimated)
- Study completion23 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier BOURRON, Dr, Principal investigator, Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639440
- Sponsor's protocol ID
- APHP200983
- Other IDs
- 2020-A02403-36
- Acronym
- COVIFAT
- Status last verified
- Oct 2020
- First submitted
- 28 Oct 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adipose Tissue in COVID-19 : From Pathophysiology to Therapeutic Perspectives
- ClinicalTrials.gov ID
- NCT04639440
- Acronym / sponsor ID
- COVIFAT / APHP200983
- Conditions
- Covid19
- Keywords
- Adipose tissue, Covid19, SARS-CoV2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 23 Nov 2020 (estimated)
- Primary completion
- 22 Nov 2021 (estimated)
- Study completion
- 23 Nov 2021 (estimated)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese or overweight patients | – | Other: Adipose tissue |
| Patients without overweight | – | Other: Adipose tissue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese and thin patients operated on for abdominal vascular surgery.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding woman
- Patient refusal
- Patient deprived of liberty or subject to a legal protection measure (guardianship, curatorship)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adipose tissueAdipose tissue sampling | Other | Obese or overweight patients, Patients without overweight |
Primary outcome
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
5 secondary outcomes
Demonstration of entry and replication of SARS-CoV-2 in human adipose tissue
Time frame: 12 months
Consequences of infection with SARS-CoV-2 on the metabolism and inflammatory state of adipose tissue.
Time frame: 12 months
Consequences of infection with SARS-CoV-2 on the metabolism and inflammatory state of adipose tissue.
Time frame: 12 months
Effect of SARS-CoV-2 infection of adipose tissue / adipocytes from thin and obese subjects on endoplasmic reticulum (ER) homeostasis.
Time frame: 12 months
Target endoplasmic reticulum stress to reduce spread of SARS-CoV-2 from adipose tissue
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier BOURRON, Dr principal investigator
Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier BOURRON, Dr (0142178118, olivier.bourron@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.