COHIVE: Coronavirus (COVID-19) Outcomes in HIV Evaluation in Resource Limited Settings
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|ClinicalTrials.gov Identifier: NCT04371835|
Recruitment Status : Recruiting
First Posted : May 1, 2020
Last Update Posted : August 28, 2020
|Condition or disease|
|HIV-infection/Aids Coronavirus Infection|
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|
|Estimated Enrollment :||1500 participants|
|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|
|Actual Study Start Date :||August 12, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
- Clinical features of symptomatic COVID-19 in people living with HIV (PLWH) [ Time Frame: At baseline ]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.
- Clinical outcomes of symptomatic COVID-19 in PLWH [ Time Frame: At Day 28 ]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.
- Clinical outcomes of symptomatic COVID-19 in PLWH [ Time Frame: At Month 3 ]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.
- Seroprevalence of COVID-19 in all parent study participants [ Time Frame: Through study completion, an average of one year ]To determine seroprevalence of COVID-19 in all parent study participants regardless of COVID-19 history.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04371835
|Contact: Maria E Arriaga, PhD||+61 2 9385 0900 ext email@example.com|
|Principal Investigator:||Alexandra Calmy, MD, PhD||University Hospital, Geneva|
|Principal Investigator:||Eric Delaporte, MD, PhD||IRD, Inserm, University of Montpellier|
|Principal Investigator:||Saye Khoo, MD, PhD||University of Liverpool|
|Principal Investigator:||Emmanuelle Papot, MD||Kirby Institute|
|Study Chair:||Mark Polizzotto, MD, PhD||Kirby Institute|
|Principal Investigator:||Francois WD Venter, MD||Wits Reproductive Health and HIV Institute|
|Principal Investigator:||Joana Woods, MD||Wits Reproductive Health and HIV Institute|