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

Sponsor

Kirby Institute (Other)

Overall Status

Completed

CT.gov ID

NCT04371835

Collaborator

University of Witwatersrand, South Africa (Other), University of Liverpool (Other), Université Montpellier (Other), UNITAID (Other), ViiV Healthcare (Industry)

596

Enrollment

Locations

16.6

Actual Duration (Months)

39.7

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV-infection/Aids Coronavirus Infection

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.

Study Design

Study Type:

Observational

Actual Enrollment :

596 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 :

Aug 12, 2020

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Outcome Measures

Primary Outcome Measures

Clinical features of symptomatic COVID-19 in people living with HIV (PLWH) [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 [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 [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.

Secondary Outcome Measures

Seroprevalence of COVID-19 in all parent study participants [Through study completion, an average of one year]
To determine seroprevalence of COVID-19 in all parent study participants regardless of COVID-19 history.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital G de Agudos JM Ramos Mejia	Buenos Aires	Ciudad De Buenos Aires	Argentina	C1221ADC
2	Laboratório de Pesquisa Clinica Em Hiv/Aids - Instituto Nacional de Infectologia - Fiocruz	Rio de Janeiro		Brazil	21040-360
3	Central Hospital of Yaoundé	Yaoundé		Cameroon
4	Cité Verte Hospital	Yaoundé		Cameroon
5	Hôpital Militaire de Région N°1	Yaoundé		Cameroon
6	CART CRS, VHS Hospital	Chennai	Tamil Nadu	India	600113
7	Univerity of Malaya Medical Centre	Kuala Lumpur		Malaysia
8	Institute of Human Virology, Nigeria (IHVN)	Abuja		Nigeria	9396
9	Desmond Tutu HIV Foundation	Cape Town		South Africa	7925
10	Perinatal HIV Research Unit (PHRU)	Johannesburg		South Africa	2013
11	Clinical HIV Research Unit (CHRU), Wits Health Consotium (Pty) Ltd	Johannesburg		South Africa	2041
12	Ezintsha	Parktown		South Africa	2193
13	HIV-NAT (The HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Centre	Bangkok		Thailand	10330
14	Infectious Diseases Institute	Kampala		Uganda
15	University of Zimbabwe Clinical Research Centre	Harare		Zimbabwe	263

Sponsors and Collaborators

Kirby Institute
University of Witwatersrand, South Africa
University of Liverpool
Université Montpellier
UNITAID
ViiV Healthcare

Investigators

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