Adult Patients Living With HIV (PLWHIV) With Confirmed Infection With SARS-CoV-2 Since 1st January 2020 Clinical Trial
— COVIDHIVOfficial title:
Clinical Characterisation Protocol for COVID-19 in People Living With HIV
Verified date | April 2020 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
There is very little data so far to determine whether people living with HIV (PLWHIV) are at
greater risk of COVID-19 acquisition or severe disease. HIV infection is associated with
deficiencies in both humoral and cell-mediated immunity that could potentially alter the
course and severity of common infections. The investigators will study the correlation
between clinical and immunovirological data. The singularity of this work is to have an
in-depth immunovirological approach linked to the clinical characteristics in COVID-19 HIV
co-infected patients. COVIDHIV is the only study to date to offer this combined approach in
PLWHIV.
This protocol is a historical and prospective cohort study of PLWHIV presenting COVID-19 The
primary objectives are to describe the course of COVID-19 disease in patients infected with
HIV
Status | Not yet recruiting |
Enrollment | 270 |
Est. completion date | October 2020 |
Est. primary completion date | October 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Inclusion criteria for the 250 patients with COVID19 - Patient living with HIV (PLWHIV) - Patient with confirmed infection with SARS-CoV-2 since 1st January 2020 with and without criteria of hospitalisation. Inclusion criteria for the 20 patients without COVID19 (who will only realize the qualitative interview) - Patient living with HIV (PLWHIV) - Patient who did not have COVID-19 Exclusion Criteria: Exclusion criteria for the 250 patients with COVID19 - Confirmed diagnosis of another pathogen than SARS-CoV-2 - Refusal by participant, or appropriate representative. - Being under guardianship or trusteeship mandate for future protection - Participate to another study without consent of the promoter - Patients less than 18 years old - No Beneficiary or entitled to a social security scheme or state medical aid. Exclusion criteria for the 20 patients without COVID19 (who will only realize the qualitative interview) - Refusal by participant, or appropriate representative. - Being under guardianship or trusteeship mandate for future protection - Participate to another study without consent of the promoter - Patients less than 18 years old - No Beneficiary or entitled to a social security scheme or state medical aid. |
Country | Name | City | State |
---|---|---|---|
France | Department of Internal Medicine and Clinical Immunology of Professor Cécile Goujard | Le Kremlin-Bicêtre |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Describe the course of COVID-19 disease in patients infected with HIV, | Biological sample collection | 6 months |