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

NCT04371835 | Completed DMC

• 1 other identifier: 2020-04-COHIVE
• Study Type: observational
• Target: 596
• Locations: 10 countries
• Sites: 15

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.

Conditions

HIV-infection/Aids; Coronavirus Infection

Keywords

Covid-19; SARS-CoV-2; HIV

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  At Month 3

Secondary Outcomes (1)

• Seroprevalence of COVID-19 in all parent study participants

  Through study completion, an average of one year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥ 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.

You may not qualify if:

• Refuse to participate in the COHIVE substudy.
• Any condition which would place the participant at risk if they participated.

Sponsors & Collaborators

• Kirby Institute: lead
• University of Witwatersrand, South Africa: collaborator
• University of Liverpool: collaborator
• Université Montpellier: collaborator
• UNITAID: collaborator
• ViiV Healthcare: collaborator

Study Sites (15)

Hospital G de Agudos JM Ramos Mejia

Buenos Aires, Buenos Aires F.D., C1221ADC, Argentina

Location

Laboratório de Pesquisa Clinica Em Hiv/Aids - Instituto Nacional de Infectologia - Fiocruz

Rio de Janeiro, 21040-360, Brazil

Location

Central Hospital of Yaoundé

Yaoundé, Cameroon

Location

Cité Verte Hospital

Yaoundé, Cameroon

Location

Hôpital Militaire de Région N°1

Yaoundé, Cameroon

Location

CART CRS, VHS Hospital

Chennai, Tamil Nadu, 600113, India

Location

Univerity of Malaya Medical Centre

Kuala Lumpur, Malaysia

Location

Institute of Human Virology, Nigeria (IHVN)

Abuja, 9396, Nigeria

Location

Desmond Tutu HIV Foundation

Cape Town, 7925, South Africa

Location

Perinatal HIV Research Unit (PHRU)

Johannesburg, 2013, South Africa

Location

Clinical HIV Research Unit (CHRU), Wits Health Consotium (Pty) Ltd

Johannesburg, 2041, South Africa

Location

Ezintsha

Parktown, 2193, South Africa

Location

HIV-NAT (The HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Centre

Bangkok, 10330, Thailand

Location

Infectious Diseases Institute

Kampala, Uganda

Location

University of Zimbabwe Clinical Research Centre

Harare, 263, Zimbabwe

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Coronaviridae Infections; Nidovirales Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Mark Polizzotto, MD, PhD

  Kirby Institute

  STUDY CHAIR

• Francois WD Venter, MD

  Wits Reproductive Health and HIV Institute

  PRINCIPAL INVESTIGATOR

• Joana Woods, MD

  Wits Reproductive Health and HIV Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 1, 2020
• Study Start: August 12, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 18, 2022

Record last verified: 2022-03

Locations

UG (1); MY (1); TH (1); ZA (4); NG (1); AR (1); CA (3); ZI (1); IN (1); BR (1)