Covid19NCT04575545
Prevalence of COVID-19 Infection in a Cohort of Patients Infected by the HIV and Patients Taking PrEP
An observational study of Covid19 and Virus-HIV, run by Hôpital Européen Marseille at 1 site in France.
Trial summary
The purpose of the study is to assess seroprevalence of COVID-19 infection in a cohort of HIV + patients and in a cohort of patients taking PrEP by emtricitabine / tenofovir. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Serology test for COVID-19
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2020to Apr 2022
- 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: patients infected by the HIV on treatment and patients taking PreP
Who may be able to join
- Aged ≥ 18 years
- patients infected by the HIV on treatment
- patients taking PreP (Pre-exposure prophylaxis (PrEP))
- Being affiliated with or benefiting from a social security scheme
Who cannot join
- Subject to a measure for the protection of justice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of COVID-19 Infection in a Cohort of Patient Infected by the HIV and Patients Taking PrEP Pre-exposure Prophylaxis
The purpose of the study is to assess seroprevalence of COVID-19 infection in a cohort of HIV + patients and in a cohort of patients taking PrEP by emtricitabine / tenofovir.
- Being tested
- Serology test for COVID-19
- Medical subject headings
- COVID-19, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serology test for COVID-19Diagnostic test
ELISA test
| Study group | Role | What they receive |
|---|---|---|
| HIV positive patients | Not described Receives: Diagnostic Test: Serology test for COVID-19 | |
| Patients taking PrEP | Not described Receives: Diagnostic Test: Serology test for COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients with positive serological tests for covid-19
Measured: 3 months
Secondary outcomes (1)
Presence and quantification of CD4 / CD8 reactivity to COVID-19 epitopes in patient with positive and negative serological tests for covid-19
% of anti-covid positive cells
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study startOct 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionApr 2022 (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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Européen Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick PHILIBERT, Principal investigator, Hôpital Europeen Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575545
- Sponsor's protocol ID
- 2020-A02018-31
- Status last verified
- Sep 2020
- First submitted
- 2 Oct 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of COVID-19 Infection in a Cohort of Patient Infected by the HIV and Patients Taking PrEP Pre-exposure Prophylaxis
- ClinicalTrials.gov ID
- NCT04575545
- Acronym / sponsor ID
- 2020-A02018-31
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hôpital Européen MarseilleUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 5 Oct 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.
The purpose of the study is to assess seroprevalence of COVID-19 infection in a cohort of HIV + patients and in a cohort of patients taking PrEP by emtricitabine / tenofovir.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV positive patients | – | Diagnostic Test: Serology test for COVID-19 |
| Patients taking PrEP | – | Diagnostic Test: Serology test for COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients infected by the HIV on treatment and patients taking PreP
Key inclusion criteria (4 listed)
- Aged ≥ 18 years
- patients infected by the HIV on treatment
- patients taking PreP (Pre-exposure prophylaxis (PrEP))
- Being affiliated with or benefiting from a social security scheme
Key exclusion criteria (1 listed)
- Subject to a measure for the protection of justice
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 |
|---|---|---|
| Serology test for COVID-19ELISA test | Diagnostic test | HIV positive patients, Patients taking PrEP |
Primary outcome
% of patients with positive serological tests for covid-19
Time frame: 3 months
1 secondary outcome
Presence and quantification of CD4 / CD8 reactivity to COVID-19 epitopes in patient with positive and negative serological tests for covid-19
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 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.
Patrick PHILIBERT principal investigator
Hôpital Europeen Marseille
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 and Virus-HIV, run by Hôpital Européen Marseille 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 1 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 5 Oct 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 Myriam BENNANI (0413428351, m.bennani@hopital-europeen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of patients with positive serological tests for covid-19 (time frame: 3 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 5 Oct 2020.