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

Coronavirus Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04371835
• Other study ID #: 2020-04-COHIVE
• Status: Completed
• Start date: August 12, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 596
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• Coronavirus Infection
• Coronavirus Infections
• COVID-19
• HIV Infections
• HIV-infection/Aids
• Infections

Locations

Country	Name	City	State
Argentina	Hospital G de Agudos JM Ramos Mejia	Buenos Aires	Ciudad De Buenos Aires
Brazil	Laboratório de Pesquisa Clinica Em Hiv/Aids - Instituto Nacional de Infectologia - Fiocruz	Rio de Janeiro
Cameroon	Central Hospital of Yaoundé	Yaoundé
Cameroon	Cité Verte Hospital	Yaoundé
Cameroon	Hôpital Militaire de Région N°1	Yaoundé
India	CART CRS, VHS Hospital	Chennai	Tamil Nadu
Malaysia	Univerity of Malaya Medical Centre	Kuala Lumpur
Nigeria	Institute of Human Virology, Nigeria (IHVN)	Abuja
South Africa	Desmond Tutu HIV Foundation	Cape Town
South Africa	Clinical HIV Research Unit (CHRU), Wits Health Consotium (Pty) Ltd	Johannesburg
South Africa	Perinatal HIV Research Unit (PHRU)	Johannesburg
South Africa	Ezintsha	Parktown
Thailand	HIV-NAT (The HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Centre	Bangkok
Uganda	Infectious Diseases Institute	Kampala
Zimbabwe	University of Zimbabwe Clinical Research Centre	Harare

Sponsors (6)

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

Countries where clinical trial is conducted

Argentina,  Brazil,  Cameroon,  India,  Malaysia,  Nigeria,  South Africa,  Thailand,  Uganda,  Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At baseline
Primary	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.	At Day 28
Primary	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.	At Month 3
Secondary	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.	Through study completion, an average of one year