COVID-19 and HIV Patients

NCT04523012 | Completed DMC

• 1 other identifier: CREPATS 013
• Study Type: observational
• Target: 2,200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (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

  12 months

Study Arms (1)

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.

Other: Seroprevalence of SARS-CoV-2 infection in patients with HIV infection

Interventions

Seroprevalence of SARS-CoV-2 infection in patients with HIV infection OTHER

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.

HIV patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida: lead

Study Sites (1)

Valérie POURCHER

Paris, Île-de-France Region, 75013, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

A venous blood sample will be taken as part of routine care for HIV: on D0 (a 6 ml tube will be collected), M6 (a 6 ml tube will be collected) and M12 (a 6 ml tube will be collected) during the recommended assessments for HIV management as part of routine care. On inclusion, after information and collection of the non-objection, a tube of blood (D0) will be collected during the assessment of the HIV infection and a control to determine the appearance or persistence of the antibodies will be done at M6 and M12 always as part of the assessment of HIV infection.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• valérie Pourcher, MD

  Pitie-Salpetriere Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 21, 2020
• Study Start: July 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2022
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)