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
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Tracking Information | ||||||||||||||||||||||
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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 |
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Original Primary Outcome Measures | Same as current | |||||||||||||||||||||
Change History | ||||||||||||||||||||||
Current Secondary Outcome Measures |
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.
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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. |
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Study Type | Observational | |||||||||||||||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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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 |
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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. |
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Recruitment Information | ||||||||||||||||||||||
Recruitment Status | Recruiting | |||||||||||||||||||||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | |||||||||||||||||||||
Accepts Healthy Volunteers | No | |||||||||||||||||||||
Contacts |
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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 |
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IPD Sharing Statement |
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Responsible Party | Kirby Institute | |||||||||||||||||||||
Study Sponsor | Kirby Institute | |||||||||||||||||||||
Collaborators |
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Investigators |
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PRS Account | Kirby Institute | |||||||||||||||||||||
Verification Date | August 2020 |