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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04371835
Other study ID # 2020-04-COHIVE
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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