- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04515225
COVID-19 Prevalence in HIV-infected Patients (SeCoVIHA)
August 2, 2021 updated by: University Hospital, Strasbourg, France
Seroprevalence of SARS-CoV-2 Antibodies Among Adult Patients Living With HIV
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Strasbourg, France, 67091
- Hopitaux Universitaires de Strasbourg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
HIV-infected patients on follow-up in a single University Hospital
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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
|
Blood Sample
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seroprevalence of SARS-CoV-2
Time Frame: 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.
|
From baseline to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 4, 2020
Primary Completion (Anticipated)
May 3, 2022
Study Completion (Anticipated)
May 3, 2022
Study Registration Dates
First Submitted
August 13, 2020
First Submitted That Met QC Criteria
August 14, 2020
First Posted (Actual)
August 17, 2020
Study Record Updates
Last Update Posted (Actual)
August 10, 2021
Last Update Submitted That Met QC Criteria
August 2, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7947
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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