Clinical trial NCT04371835: COHIVE: Coronavirus (COVID-19) Outcomes in HIV Evaluation in Resource Limited Settings
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-infection/Aids
Coronavirus Infection
Keywords: Covid-19
SARS-CoV-2
HIV
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
Collaborators: name: University of Witwatersrand, South Africa
name: University of Liverpool
name: Université Montpellier
name: UNITAID
name: ViiV Healthcare
First posted: 2020-05-01
Enrollment: 596
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The substudy will be proposed to all the sites participating in ADVANCE, D²EFT, DolPHIN2 and NAMSAL studies. This substudy will enrol eligible patients with i) confirmed or suspected infection with SARS-CoV-2 and ii) any participants of the 4 parent studies who accept to enrol in the seroprevalence cohort during a scheduled parent study protocol visit following control of the epidemic in country.

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.

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.

Primary outcomes:
measure: Clinical features of symptomatic COVID-19 in people living with HIV (PLWH)
timeFrame: At baseline
measure: Clinical outcomes of symptomatic COVID-19 in PLWH
timeFrame: At Day 28
measure: Clinical outcomes of symptomatic COVID-19 in PLWH
timeFrame: At Month 3
Secondary outcomes:
measure: Seroprevalence of COVID-19 in all parent study participants
timeFrame: Through study completion, an average of one year
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital G de Agudos JM Ramos Mejia
state: Ciudad De Buenos Aires
city: Rio de Janeiro
country: Brazil
facility: Laboratório de Pesquisa Clinica Em Hiv/Aids - Instituto Nacional de Infectologia - Fiocruz
city: Yaoundé
country: Cameroon
facility: Central Hospital of Yaoundé
city: Yaoundé
country: Cameroon
facility: Cité Verte Hospital
city: Yaoundé
country: Cameroon
facility: Hôpital Militaire de Région N°1
city: Chennai
country: India
facility: CART CRS, VHS Hospital
state: Tamil Nadu
city: Kuala Lumpur
country: Malaysia
facility: Univerity of Malaya Medical Centre
city: Abuja
country: Nigeria
facility: Institute of Human Virology, Nigeria (IHVN)
city: Cape Town
country: South Africa
facility: Desmond Tutu HIV Foundation
city: Johannesburg
country: South Africa
facility: Perinatal HIV Research Unit (PHRU)
city: Johannesburg
country: South Africa
facility: Clinical HIV Research Unit (CHRU), Wits Health Consotium (Pty) Ltd
city: Parktown
country: South Africa
facility: Ezintsha
city: Bangkok
country: Thailand
facility: HIV-NAT (The HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Centre
city: Kampala
country: Uganda
facility: Infectious Diseases Institute
city: Harare
country: Zimbabwe
facility: University of Zimbabwe Clinical Research Centre
Study officials:
affiliation: University Hospital, Geneva
name: Alexandra Calmy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRD, Inserm, University of Montpellier
name: Eric Delaporte, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Liverpool
name: Saye Khoo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kirby Institute
name: Emmanuelle Papot, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kirby Institute
name: Mark Polizzotto, MD, PhD
role: STUDY_CHAIR
affiliation: Wits Reproductive Health and HIV Institute
name: Francois WD Venter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wits Reproductive Health and HIV Institute
name: Joana Woods, MD
role: PRINCIPAL_INVESTIGATOR
References: