Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-01 @ 9:52 PM
Study NCT ID:
NCT04371835
Status:
COMPLETED
Last Update Posted:
2022-03-18
First Post:
2020-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COHIVE: Coronavirus (COVID-19) Outcomes in HIV Evaluation in Resource Limited Settings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 596}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-16', 'studyFirstSubmitDate': '2020-04-28', 'studyFirstSubmitQcDate': '2020-04-30', 'lastUpdatePostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical features of symptomatic COVID-19 in people living with HIV (PLWH)', 'timeFrame': 'At baseline', 'description': '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.'}, {'measure': 'Clinical outcomes of symptomatic COVID-19 in PLWH', 'timeFrame': 'At Day 28', 'description': '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.'}, {'measure': 'Clinical outcomes of symptomatic COVID-19 in PLWH', 'timeFrame': 'At Month 3', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Seroprevalence of COVID-19 in all parent study participants', 'timeFrame': 'Through study completion, an average of one year', 'description': 'To determine seroprevalence of COVID-19 in all parent study participants regardless of COVID-19 history.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid-19', 'SARS-CoV-2', 'HIV'], 'conditions': ['HIV-infection/Aids', 'Coronavirus Infection']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nEnrolment 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years old.\n* 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.\n* Have signed the informed consent of one of the parent study.\n* Give informed consent to the COHIVE substudy.\n\nExclusion Criteria:\n\n* Refuse to participate in the COHIVE substudy.\n* Any condition which would place the participant at risk if they participated.'}, 'identificationModule': {'nctId': 'NCT04371835', 'briefTitle': 'COHIVE: Coronavirus (COVID-19) Outcomes in HIV Evaluation in Resource Limited Settings', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kirby Institute'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2020-04-COHIVE'}}, 'contactsLocationsModule': {'locations': [{'zip': 'C1221ADC', 'city': 'Buenos Aires', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Hospital G de Agudos JM Ramos Mejia', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '21040-360', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Laboratório de Pesquisa Clinica Em Hiv/Aids - Instituto Nacional de Infectologia - Fiocruz', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'Yaoundé', 'country': 'Cameroon', 'facility': 'Central Hospital of Yaoundé', 'geoPoint': {'lat': 3.86667, 'lon': 11.51667}}, {'city': 'Yaoundé', 'country': 'Cameroon', 'facility': 'Cité Verte Hospital', 'geoPoint': {'lat': 3.86667, 'lon': 11.51667}}, {'city': 'Yaoundé', 'country': 'Cameroon', 'facility': 'Hôpital Militaire de Région N°1', 'geoPoint': {'lat': 3.86667, 'lon': 11.51667}}, {'zip': '600113', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'CART CRS, VHS Hospital', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Univerity of Malaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '9396', 'city': 'Abuja', 'country': 'Nigeria', 'facility': 'Institute of Human Virology, Nigeria (IHVN)', 'geoPoint': {'lat': 9.05785, 'lon': 7.49508}}, {'zip': '7925', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Desmond Tutu HIV Foundation', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '2013', 'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Perinatal HIV Research Unit (PHRU)', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '2041', 'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Clinical HIV Research Unit (CHRU), Wits Health Consotium (Pty) Ltd', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '2193', 'city': 'Parktown', 'country': 'South Africa', 'facility': 'Ezintsha', 'geoPoint': {'lat': -26.18205, 'lon': 28.02671}}, {'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'HIV-NAT (The HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Centre', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Kampala', 'country': 'Uganda', 'facility': 'Infectious Diseases Institute', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'zip': '263', 'city': 'Harare', 'country': 'Zimbabwe', 'facility': 'University of Zimbabwe Clinical Research Centre', 'geoPoint': {'lat': -17.82772, 'lon': 31.05337}}], 'overallOfficials': [{'name': 'Alexandra Calmy, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Geneva'}, {'name': 'Eric Delaporte, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRD, Inserm, University of Montpellier'}, {'name': 'Saye Khoo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Liverpool'}, {'name': 'Emmanuelle Papot, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kirby Institute'}, {'name': 'Mark Polizzotto, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kirby Institute'}, {'name': 'Francois WD Venter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wits Reproductive Health and HIV Institute'}, {'name': 'Joana Woods, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wits Reproductive Health and HIV Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kirby Institute', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Witwatersrand, South Africa', 'class': 'OTHER'}, {'name': 'University of Liverpool', 'class': 'OTHER'}, {'name': 'Université Montpellier', 'class': 'OTHER'}, {'name': 'UNITAID', 'class': 'OTHER'}, {'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}