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

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ClinicalTrials.gov Identifier: NCT04371835
Recruitment Status : Recruiting
First Posted : May 1, 2020
Last Update Posted : August 28, 2020
Sponsor:
Collaborators:
University of Witwatersrand, South Africa
University of Liverpool
Université Montpellier
UNITAID
Information provided by (Responsible Party):
Kirby Institute

Study Description
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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
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
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Study Type : Observational
Estimated Enrollment : 1500 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 : August 12, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04371835


Contacts
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Contact: Maria E Arriaga, PhD +61 2 9385 0900 ext 50401 cohive@kirby.unsw.edu.au

Locations
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Nigeria
Institute of Human Virology, Nigeria (IHVN) Recruiting
Abuja, Nigeria, 9396
Contact: Nnakelu Eriobu    +2347039469273    neriobu@ihvnigeria.org   
Contact: Maryam Almujtaba    +2347039469273    malmujtaba@ihvnigeria.org   
Principal Investigator: Nnakelu Eriobu, MD         
Sponsors and Collaborators
Kirby Institute
University of Witwatersrand, South Africa
University of Liverpool
Université Montpellier
UNITAID
Investigators
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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
More Information
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Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT04371835    
Other Study ID Numbers: 2020-04-COHIVE
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kirby Institute:
Covid-19
SARS-CoV-2
HIV
Additional relevant MeSH terms:
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Infection
Communicable Diseases
HIV Infections
Coronavirus Infections
Severe Acute Respiratory Syndrome
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Coronaviridae Infections
Nidovirales Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Slow Virus Diseases