HIV-infection/AidsNCT04371835
COHIVE: Coronavirus (COVID-19) Outcomes in HIV Evaluation in Resource Limited Settings
An observational study of HIV-infection/Aids and Coronavirus Infection, run by Kirby Institute at 15 sites in 10 countries.
Trial summary
COHIVE is an observational cohort nested in four antiretroviral therapy research studies (ADVANCE - NCT03122262; D²EFT - NCT03017872; DolPHIN2 - NCT03249181 and NAMSAL-ANRS12313 - NCT02777229). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-infection/Aids, Coronavirus Infection
- How many people
- 596 participants
- Where
- 15 sitesin 10 countries
- Study dates
- 12 Aug 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥ 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.
Who cannot join
- Refuse to participate in the COHIVE substudy.
- Any condition which would place the participant at risk if they participated.
Trial locations and contacts
15 sites in 10 countries.
15 sites in 10 countries
South Africa4 sites
Desmond Tutu HIV Foundation
Cape Town, 7925
Perinatal HIV Research Unit (PHRU)
Johannesburg, 2013
Clinical HIV Research Unit (CHRU), Wits Health Consotium (Pty) Ltd
Johannesburg, 2041
Ezintsha
Parktown, 2193
Cameroon3 sites
Central Hospital of Yaoundé
Yaoundé
Cité Verte Hospital
Yaoundé
Hôpital Militaire de Région N°1
Yaoundé
Argentina1 site
Hospital G de Agudos JM Ramos Mejia
Buenos Aires, Buenos Aires F.D., C1221ADC
Brazil1 site
Laboratório de Pesquisa Clinica Em Hiv/Aids - Instituto Nacional de Infectologia - Fiocruz
Rio de Janeiro, 21040-360
Thailand1 site
HIV-NAT (The HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Centre
Bangkok, 10330
About this study
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
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.
Read the 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.
- Conditions
- HIV-infection/Aids, Coronavirus Infection
- Keywords
- Covid-19, SARS-CoV-2, HIV
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Coronavirus Infections, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline
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.
Measured: At Day 28
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.
Measured: At Month 3
Secondary outcomes (1)
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.
Measured: Through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start12 Aug 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-infection/AidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- University of Witwatersrand, South Africa, University of Liverpool, Université Montpellier, UNITAID, ViiV Healthcare
- Responsible party
- Sponsor
- Investigators
- Alexandra Calmy, MD, PhD, Principal investigator, University Hospital, GenevaEric Delaporte, MD, PhD, Principal investigator, IRD, Inserm, University of MontpellierSaye Khoo, MD, PhD, Principal investigator, University of LiverpoolEmmanuelle Papot, MD, Principal investigator, Kirby InstituteMark Polizzotto, MD, PhD, Study chair, Kirby InstituteFrancois WD Venter, MD, Principal investigator, Wits Reproductive Health and HIV InstituteJoana Woods, MD, Principal investigator, Wits Reproductive Health and HIV Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371835
- Sponsor's protocol ID
- 2020-04-COHIVE
- Status last verified
- Mar 2022
- First submitted
- 28 Apr 2020
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04371835
- Acronym / sponsor ID
- 2020-04-COHIVE
- Conditions
- HIV-infection/Aids, Coronavirus Infection
- Keywords
- Covid-19, SARS-CoV-2, HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- University of Witwatersrand, South Africa, University of Liverpool, Université Montpellier, UNITAID, ViiV Healthcare
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- ≥ 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.
Key exclusion criteria (2 listed)
- Refuse to participate in the COHIVE substudy.
- Any condition which would place the participant at risk if they participated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Seroprevalence of COVID-19 in all parent study participants
Time frame: Through study completion, an average of one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Calmy, MD, PhD principal investigator
University Hospital, Geneva
Eric Delaporte, MD, PhD principal investigator
IRD, Inserm, University of Montpellier
Saye Khoo, MD, PhD principal investigator
University of Liverpool
15 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-infection/Aids and Coronavirus Infection, run by Kirby Institute at 15 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in South Africa, Cameroon, Argentina, Brazil, India and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical features of symptomatic COVID-19 in people living with HIV (PLWH) (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.