SeCoVIHA: COVID-19 Prevalence in HIV-infected Patients

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04515225

Collaborator

(none)

500

Enrollment

Location

17.9

Anticipated Duration (Months)

27.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Other: Blood Sample

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 4, 2020

Anticipated Primary Completion Date :

May 3, 2022

Anticipated Study Completion Date :

May 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
HIV-infected patients All HIV-infected patients on active follow-up, whatever clinical and biological condition, on ARV treatment or not, and whatever ARV combination	Other: Blood Sample Blood Sample

Arm

Intervention/Treatment

HIV-infected patients

All HIV-infected patients on active follow-up, whatever clinical and biological condition, on ARV treatment or not, and whatever ARV combination

Other: Blood Sample

Blood Sample

Outcome Measures

Primary Outcome Measures

Seroprevalence of SARS-CoV-2 [From baseline to 12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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