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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

Tracking Information
First Submitted Date April 28, 2020
First Posted Date May 1, 2020
Last Update Posted Date August 28, 2020
Actual Study Start Date August 12, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 30, 2020)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 30, 2020)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • HIV-infection/Aids
  • Coronavirus Infection
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 30, 2020)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Maria E Arriaga, PhD +61 2 9385 0900 ext 50401 cohive@kirby.unsw.edu.au
Listed Location Countries Nigeria
Removed Location Countries  
 
Administrative Information
NCT Number NCT04371835
Other Study ID Numbers 2020-04-COHIVE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Kirby Institute
Study Sponsor Kirby Institute
Collaborators
  • University of Witwatersrand, South Africa
  • University of Liverpool
  • Université Montpellier
  • UNITAID
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
PRS Account Kirby Institute
Verification Date August 2020