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

March 16, 2022 updated by: Kirby Institute

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

596

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical features of symptomatic COVID-19 in people living with HIV (PLWH)
Time Frame: 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.
At baseline
Clinical outcomes of symptomatic COVID-19 in PLWH
Time Frame: 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.
At Day 28
Clinical outcomes of symptomatic COVID-19 in PLWH
Time Frame: 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.
At Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroprevalence of COVID-19 in all parent study participants
Time Frame: Through study completion, an average of one year
To determine seroprevalence of COVID-19 in all parent study participants regardless of COVID-19 history.
Through study completion, an average of one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirby Institute

Collaborators

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

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

April 28, 2020

First Submitted That Met QC Criteria

April 30, 2020

First Posted (Actual)

May 1, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-04-COHIVE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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