Covid-19 PatientsTA/SARS-Cov2NCT04427878
Is Adipose Tissue a Reservoir for SARS-Cov2 Spread in Covid-19 Patients?
A study testing biopsies of subcutaneous adipose tissue in people with Covid-19 Patients, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19 Patients
- What is being tested?
- biopsies of subcutaneous adipose tissue
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 3 Aug 2020to 9 Sep 2020
- Phase
- Interventional
- 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
Who may be able to join
- Male or female ≥ 18 years old
- Patients testing positive for Covid19
- Patients affiliated to social security
- Signing of free and informed consent
Who cannot join
- Vulnerable persons (- minors,
- adults under guardianship or curatorship,
- pregnant women,
- persons deprived of their liberty,
- persons who do not master the French language)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Adipose Tissue a Reservoir for SARS-Cov2 Spread?
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.
- Conditions
- Covid-19 Patients
- Being tested
- biopsies of subcutaneous adipose tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsies of subcutaneous adipose tissueProcedure or surgery
Two 4mm punch biopsies of subcutaneous abdominal or thight adipose tissue
| Study group | Role | What they receive |
|---|---|---|
| patients with Covid-19 | Experimental | Not described Receives: Procedure: biopsies of subcutaneous adipose tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of SARS-CoV2 in adipose tissue of Covid19 patients
RT-qPCR for SARS-Cov-2 from RNAs and by immunodetection
Measured: Day 0
Secondary outcomes (3)
The expression of inflammatory cytokines in adipose tissue of Covid19 patients
RT-qPCR for IL6
Measured: Day 0
The expression of inflammatory cytokines in adipose tissue of Covid19 patients
RT-qPCR for IL1
Measured: Day 0
The expression of inflammatory cytokines in adipose tissue of Covid19 patients
RT-qPCR for TNFa
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start3 Aug 2020
- Primary completion9 Sep 2020
- Study completion9 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19 PatientsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427878
- Sponsor's protocol ID
- 20-PP-15
- Acronym
- TA/SARS-Cov2
- Status last verified
- Nov 2023
- First submitted
- 10 Jun 2020
- Last updated
- 27 Jun 2024
- 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 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Adipose Tissue a Reservoir for SARS-Cov2 Spread?
- ClinicalTrials.gov ID
- NCT04427878
- Acronym / sponsor ID
- TA/SARS-Cov2 / 20-PP-15
- Conditions
- Covid-19 Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 11 Jun 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with Covid-19 | Experimental | Procedure: biopsies of subcutaneous adipose tissue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ≥ 18 years old
- Patients testing positive for Covid19
- Patients affiliated to social security
- Signing of free and informed consent
Key exclusion criteria (5 listed)
- Vulnerable persons (- minors,
- adults under guardianship or curatorship,
- pregnant women,
- persons deprived of their liberty,
- persons who do not master the French language)
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 |
|---|---|---|
| biopsies of subcutaneous adipose tissueTwo 4mm punch biopsies of subcutaneous abdominal or thight adipose tissue | Procedure or surgery | patients with Covid-19 |
Primary outcome
The presence of SARS-CoV2 in adipose tissue of Covid19 patients
Time frame: Day 0
RT-qPCR for SARS-Cov-2 from RNAs and by immunodetection
3 secondary outcomes
The expression of inflammatory cytokines in adipose tissue of Covid19 patients
Time frame: Day 0
The expression of inflammatory cytokines in adipose tissue of Covid19 patients
Time frame: Day 0
The expression of inflammatory cytokines in adipose tissue of Covid19 patients
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biopsies of subcutaneous adipose tissue in people with Covid-19 Patients, run by Centre Hospitalier Universitaire de Nice 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 27 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presence of SARS-CoV2 in adipose tissue of Covid19 patients (time frame: Day 0). 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 27 Jun 2024.