COHIVE: Coronavirus (COVID-19) Outcomes in HIV Evaluation in Resource Limited Settings
NCT ID: NCT04371835
Last Updated: 2022-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
596 participants
OBSERVATIONAL
2020-08-12
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* Any condition which would place the participant at risk if they participated.
18 Years
ALL
No
Sponsors
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University of Witwatersrand, South Africa
OTHER
University of Liverpool
OTHER
Université Montpellier
OTHER
UNITAID
OTHER
ViiV Healthcare
INDUSTRY
Kirby Institute
OTHER_GOV
Responsible Party
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Principal Investigators
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Alexandra Calmy, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Geneva
Eric Delaporte, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
IRD, Inserm, University of Montpellier
Saye Khoo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Liverpool
Emmanuelle Papot, MD
Role: PRINCIPAL_INVESTIGATOR
Kirby Institute
Mark Polizzotto, MD, PhD
Role: STUDY_CHAIR
Kirby Institute
Francois WD Venter, MD
Role: PRINCIPAL_INVESTIGATOR
Wits Reproductive Health and HIV Institute
Joana Woods, MD
Role: PRINCIPAL_INVESTIGATOR
Wits Reproductive Health and HIV Institute
Locations
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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
Central Hospital of Yaoundé
Yaoundé, , Cameroon
Cité Verte Hospital
Yaoundé, , Cameroon
Hôpital Militaire de Région N°1
Yaoundé, , Cameroon
CART CRS, VHS Hospital
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
Clinical HIV Research Unit (CHRU), Wits Health Consotium (Pty) Ltd
Johannesburg, , South Africa
Ezintsha
Parktown, , South Africa
HIV-NAT (The HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Centre
Bangkok, , Thailand
Infectious Diseases Institute
Kampala, , Uganda
University of Zimbabwe Clinical Research Centre
Harare, , Zimbabwe
Countries
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Other Identifiers
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2020-04-COHIVE
Identifier Type: -
Identifier Source: org_study_id
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