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AzTrials

Covid19COCOVIHNCT04523012

COVID-19 and HIV Patients

An observational study of Covid19, run by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

As of May 26, 2020, 5,508,904 confirmed cases (145,279 in France) of COVID-19 and 346,508 deaths (28,457 in France) have been reported since December 8, 2019 worldwide. The rapid increase in the number of cases in our territory caused France to pass to level 3 of the epidemic on March 14, 2020. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
Seroprevalence of SARS-CoV-2 infection in patients with HIV infection
How many people
2,200 participants
Where
1 siteFrance
Study dates
1 Jul 2020to 30 Jun 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: This is a retrospective and prospective cohort study of patients infected with HIV to determine the seroprevalence of COVID-19 infection. This is a monocentric cohort at the Pitié-Salpêtrière hospital.

Who may be able to join

  • Age greater than or equal to 18 years
  • HIV + patient followed at the Pitié-Salpêtrière hospital
  • Known HIV infection
  • Having been informed about the study and having given oral consent (no opposition)
  • Beneficiary or entitled to a social security scheme

Who cannot join

  • Refusal of participation by the patient
  • Patient subject to a legal protection measure

Trial locations and contacts

1 site in 1 country.

France1 site
  • Valérie POURCHER

    Paris, Île-de-France Region, 75013

Other trials in France

About this study

Official title: Seroprevalence of SARS-CoV-2 Infection in Patients With HIV Infection

As of May 26, 2020, 5,508,904 confirmed cases (145,279 in France) of COVID-19 and 346,508 deaths (28,457 in France) have been reported since December 8, 2019 worldwide. The rapid increase in the number of cases in our territory caused France to pass to level 3 of the epidemic on March 14, 2020.

The natural history of this disease is still poorly understood, particularly in patients infected with HIV, patients considered to be at higher risk for severe forms.

Knowing the seroprevalence in the population of people living with HIV will make it possible to better understand the Covid infection in immunocompromised patients, know the percentage of immunization and the persistence or not of the antibodies over time, specify the protective nature or not of these antibodies detected.

Read the detailed description

To date, very little data is available in HIV-infected patients with Sars-Cov-2 infection. Only 11 cases of HIV patients with confirmed Sars-Cov-2 infection have been described in the literature. These patients are under 50 years of age, HIV infection with a controlled viral load in 8/11, 2 patients with a severe course requiring administration of tociluzumab, including one patient who died. In addition, the management of these HIV patients is not codified. Some authors have changed antiretroviral therapy to a protease inhibitor such as lopinavir or darunavir because of encouraging results in vitro but debated in patients. This clearly illustrates the disparity of approaches and the lack of data in this patient population.

Knowing the seroprevalence in the population of people living with HIV will allow us to better understand the Covid-19 infection in immunocompromised patients, know the percentage of immunization and the persistence or not of the antibodies over time as well as their unknown neutralizing effect. until now. No data exist on seroprevalence in the HIV population.

Serological tests can detect the immune response to COVID-19 in serum. Studies to date have shown seroconversion typically within two weeks of symptom onset, with notable differences depending on the studies, techniques and epitopes of the antigens chosen to detect the antibodies. A study which showed that the seropositivity rate reached 50% on the 11th day and 100% on the 39th day with a seroconversion time of 11, 12 and 14 days in median for the total antibodies, IgM and IgG.

Diagnosis of SARS-CoV-2 infection is a major public health issue. Serological tests are currently being developed. Enzyme-linked immunosorbent assay, performed on blood samples, can be performed in an automated manner and provide an estimate of the level of circulating antibody.

These serological tests could identify patients who have developed immunity to SARS-CoV-2 and be useful in the collection of epidemiological data related to COVID-19 or to know the serological status of exposed persons.

Nevertheless, SARS-CoV-2 is a new emerging virus and the antibody response (quantitative and qualitative) in COVID-19 patients is largely unknown and that of patients of HIV patients completely unknown to date. The relevance of the use of serological tests in clinical practice will indeed depend on the prior availability of physiopathological and clinical knowledge allowing their interpretation and ensuring adequate indications such as those recently proposed by the Haute Autorité de Santé ((https: //www.has -sante.fr/jcms/p_3182370/fr/premieres-indications-pour-les-tests-serologiques-du-covid-19, # 9268)).

Studies to date have shown seroconversion typically within two weeks of symptom onset, with notable differences depending on the studies, techniques and epitopes of the antigens chosen to detect the antibodies. A study which showed that the seropositivity rate reached 50% on the 11th day and 100% on the 39th day with a seroconversion time of 11, 12 and 14 days in median for the total antibodies, IgM and IgG.

Also, the immune response does not always mean protective immunization against further infection with the same virus. Only so-called neutralizing antibodies can obtain such protection. But the titer of neutralizing antibody needed to provide protection is still unknown for SARS-CoV-2. To date, the target epitopes of neutralizing antibodies have not yet been identified. In addition, data demonstrating protective immunity against COVID-19 induced by antibodies produced against SARS-CoV-2 are currently very limited.

A Chinese study that studied the antibody response in 175 patients with mild forms of COVID-19 found that 30% of them had low neutralizing antibody titer at the end of hospitalization. Differences in the titer of neutralizing antibodies were observed depending on the age of the patients, the oldest (40-59 and 60-85 years) having higher titers than the youngest (15-39 years). The titers remained stable on a control two weeks later (47/175 patients). This study raises the question of the protection of the duration of this protection.

This is why it is essential to characterize in depth the prevalence of Sars-Cov-2 infection in patients infected with HIV, patients considered to be at high risk of severe forms, and the evolution of antibody production according to the evolution of the epidemic and their protective role over time.

To date, no specific treatment or therapeutic strategy has demonstrated its effectiveness for COVID-19. Some antiretrovirals such as lopinavir / ritonavir, with in vitro activity on Sars-Cov-2, have been tested in real life with discordant results. It will be interesting to look at the antiretroviral treatments of patients who have had a Covid compared to those seronegative in serology.

Conditions
Covid19
Being tested
Seroprevalence of SARS-CoV-2 infection in patients with HIV infection
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Seroprevalence of SARS-CoV-2 infection in patients with HIV infectionOther

    On inclusion, after information and collection of the non-objection, a blood sample (D0) will be taken during the assessment of the HIV infection (no unplanned sample will be taken) and a control to determine the appearance or the Persistence of antibodies will be made at M6 and M12 always as part of the assessment of HIV infection.

Study groups in NCT04523012
Study groupRoleWhat they receive
HIV patientsOn inclusion, after information and collection of the non-objection, a blood sample (D0) will be taken during the assessment of the HIV infection (no unplanned sample will be taken) and a control to determine the appearance or the Persistence of antibodies will be made at M6 and M12 always as part of the assessment of HIV infection.
Receives: Other: Seroprevalence of SARS-CoV-2 infection in patients with HIV infection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measure of seroprevalence of COVID-19 infection assessed by the level of anti-Covid-19 IgG antibodies in the population of people living with HIV monitored at the Pitié-Salpêtrière hospital

    Measure of anti-SARS-CoV-2 antibodies using Abbott system

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2020
  2. Study start1 Jul 2020
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2022

Resources

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
Retrospective
Enrolment
2,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04523012
Sponsor's protocol ID
CREPATS 013
Acronym
COCOVIH
Status last verified
May 2023
First submitted
20 Aug 2020
Last updated
12 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19, run by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida 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 5 inclusion and 2 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 12 May 2023. 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?

Measure of seroprevalence of COVID-19 infection assessed by the level of anti-Covid-19 IgG antibodies in the population of people living with HIV monitored at the Pitié-Salpêtrière hospital (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 12 May 2023.

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