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.
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.
Study Type
OBSERVATIONAL
Enrollment
596
Hospital G de Agudos JM Ramos Mejia
Buenos Aires, Buenos Aires F.D., Argentina
Laboratório de Pesquisa Clinica Em Hiv/Aids - Instituto Nacional de Infectologia - Fiocruz
Rio de Janeiro, Brazil
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.
Time frame: 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.
Time frame: 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.
Time frame: At Month 3
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.
Time frame: Through study completion, an average of one year
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Chennai, Tamil Nadu, India
Univerity of Malaya Medical Centre
Kuala Lumpur, Malaysia
Institute of Human Virology, Nigeria (IHVN)
Abuja, Nigeria
Desmond Tutu HIV Foundation
Cape Town, South Africa
Perinatal HIV Research Unit (PHRU)
Johannesburg, South Africa
...and 5 more locations