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NCT04515225 Clinical Trial

COVID-19 Prevalence in HIV-infected Patients

HIV Infections Clinical Trial

— SeCoVIHA  

Official title:
Seroprevalence of SARS-CoV-2 Antibodies Among Adult Patients Living With HIV

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04515225
Other study ID # 7947
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 4, 2020
Est. completion date May 3, 2022

Study information
Verified date August 2021
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

North-east area of France was hit in February 2020 by the new coronavirus disease, more severely than other French regions. Factors affecting the evolution of the disease and its severity have been quickly identified, among them figuring different kinds of immune deficiency. Even if nowadays HIV infection is usually well controlled by ARV drugs, those patients with uncontrolled viral load and/or low CD4 cell counts, remain at higher risk of severe COVID infection. In this context, the primary objective of our study is aimed at evaluating the prevalence of SARS-CoV-2 antibodies in a cohort of HIV-infected patients followed-up in an HIV-infection care center. Secondary objectives are: evaluating whether the antibodies are protective or not, the kinetic of these antibodies, and HIV associated factors with the presence of antibodies.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 500
Est. completion date May 3, 2022
Est. primary completion date May 3, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - adults (> 18 years) - HIV-infected patients - subjects with social insurance - subjects able to understand study purposes, and to give a written and informed consent Exclusion Criteria : - subjects unable to understand informations on the study, and to provide informed consent - subjects under guardianship or curatorship - subjects under judicial protection

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Blood Sample
Blood Sample

Locations
Country Name City State
France Hôpitaux Universitaires de Strasbourg Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Seroprevalence of SARS-CoV-2 SARS-CoV-2 antibodies will be detected with a rapid test detecting IgG and IgM, at inclusion, and during a 6-month and a 12-month visit, in order to assess the prevalence of the virus in this population. From baseline to 12 months
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