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.
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.
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 group | Role | What they receive |
|---|---|---|
| HIV patients | 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. 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.
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.
- First posted21 Aug 2020
- Study start1 Jul 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2022
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
- Retrospective
- Enrolment
- 2,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- valérie Pourcher, MD, Principal investigator, Pitie-Salpetriere Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of SARS-CoV-2 Infection in Patients With HIV Infection
- ClinicalTrials.gov ID
- NCT04523012
- Acronym / sponsor ID
- COCOVIH / CREPATS 013
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,200 participants (actual)
- Lead sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le SidaUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 21 Aug 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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV patients | – | Other: Seroprevalence of SARS-CoV-2 infection in patients with HIV infectionOn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Refusal of participation by the patient
- Patient subject to a legal protection measure
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 |
|---|---|---|
| Seroprevalence of SARS-CoV-2 infection in patients with HIV infectionOn 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. | Other | HIV patients |
Primary outcome
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
Measure of anti-SARS-CoV-2 antibodies using Abbott system
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 12 May 2023.
- Individual participant dataSharing planned: No
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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.
valérie Pourcher, MD principal investigator
Pitie-Salpetriere Hospital
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 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.