COHIVE: Coronavirus (COVID-19) Outcomes in HIV Evaluation in Resource Limited Settings

Study Overview
=================
Brief Summary
-----------------
COHIVE is an observational cohort nested in four antiretroviral therapy research studies (ADVANCE - NCT03122262; D²EFT - NCT03017872; DolPHIN2 - NCT03249181 and NAMSAL-ANRS12313 - NCT02777229). COHIVE will include participants who are possible COVID-19 cases with symptoms or confirmed COVID-19 cases, and participants who agree to have a serology testing for SARS-CoV-2 regardless of COVID-19 history.

Detailed Description
-----------------
COHIVE is an observational cohort study nested within four parent open label randomised clinical trials of first- and second-line antiretroviral therapies (ADVANCE - NCT03122262; D²EFT - NCT03017872; DolPHIN2 - NCT03249181 and NAMSAL-ANRS12313 - NCT02777229). COHIVE objective is to study the occurrence and outcomes of COVID-19 in people living with HIV across a variety of clinical settings. Taken together, these pivotal trials provide an established population and encompass a range of HIV therapies, HIV populations, and geographic regions to capture the full spectrum of these global public health emergency as it pertains to people living with HIV. The sample will include participants who are possible symptomatic or confirmed COVID-19 cases, and participants who agree to enrol in the SARS-CoV-2 seroprevalence cohort (regardless of SARS-CoV-2 infection). Approximately 2,500 participants are enrolled in these 4 studies. Enrolment into COHIVE substudy is voluntary and optional for participants in ADVANCE, D²EFT, DolPHIN2 and NAMSAL studies. Parameters relevant to COHIVE substudy including demographics, arm of randomised ART, medical and HIV history, immunological and virological results, adverse events at required time points will be collected as part of parent studies. Substudy specific assessments performed at baseline include optional sample collection for SARS-CoV-2 RT-PCR and serology; for the possible symptomatic or confirmed COVID-19 cases, the management of the patients, diagnostic test results, and outcomes, will be collected.

Official Title
-----------------
COVID-19 in People Living With HIV: Evaluation of Risk Factors and Outcomes in Resource-limited Settings. A Pooled Substudy of ADVANCE, D²EFT, DolPHIN2 and NAMSAL

Conditions
-----------------
HIV-infection/Aids, Coronavirus Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years old. Either: i) Meet local testing criteria for COVID-19, or present with symptoms that in the opinion of the investigator are consistent with COVID-19 and do not have an alternative explanation, or have tested elsewhere and found positive for COVID-19; OR ii) Agree for serology testing for SARS-CoV2, regardless of history of COVID-19. Have signed the informed consent of one of the parent study. Give informed consent to the COHIVE substudy. Exclusion Criteria: Refuse to participate in the COHIVE substudy. Any condition which would place the participant at risk if they participated.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical features of symptomatic COVID-19 in people living with HIV (PLWH) | To characterise the clinical features of symptomatic COVID-19 in PLWH (cardio-respiratory and other clinical signs or symptoms), described overall and by HIV and comorbid disease factors including pregnancy status. | At baseline | 
| Clinical outcomes of symptomatic COVID-19 in PLWH | To characterise the clinical outcomes of symptomatic COVID-19 in PLWH, assessing the outcomes of patients including the percentage of patients who are fully recovered, required hospitalisation, developed severe illness (ICU admission or equivalent) or died. | At Day 28 | 
| Clinical outcomes of symptomatic COVID-19 in PLWH | To characterise the clinical outcomes of symptomatic COVID-19 in PLWH, assessing the outcomes of patients including the percentage of patients who are fully recovered, required hospitalisation, developed severe illness (ICU admission or equivalent) or died. | At Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprevalence of COVID-19 in all parent study participants | To determine seroprevalence of COVID-19 in all parent study participants regardless of COVID-19 history. | Through study completion, an average of one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid-19, SARS-CoV-2, HIV