HIV-1 & Coronavirus-Coinfection in Europe: Morbidity & Risk Factors of COVID-19 in People Living With HIV

NCT05481216 | Completed Results

• 1 other identifier: 303CoCo
• Study Type: observational
• Target: 2,598
• Locations: 5 countries
• Sites: 23

Brief Summary

HIV CoCo is a European multi-centre, multi-country, retrospective, observational case-control study that will aim to describe clinical outcomes and identify risk factors for People Living With HIV (PLWHIV) who are co-infected with the SARS-CoV-2 coronavirus. The study will address two central questions:

1. 1.Is there a particular risk for COVID-19 in PLWHIV as compared to HIV seronegative control COVID-19 cases?
2. 2.Are there particular factors, within the group of PLWHIV, which put them at risk for a more severe COVID-19 disease course?
3. 3.Describe the differences in the clinical manifestation of COVID-19 in PLWHIV compared to HIV seronegative controls
4. 4.Describe the response to treatment, including supportive care and novel therapies against COVID-19, including antiviral or immunomodulatory therapy
5. 5.Describe the co-morbidities in PLWHIV and controls with COVID-19
6. 6.Compare the severity of COVID-19 between PLWHIV and the COVID-19 only controls at diagnosis and hospital admission.

Conditions

HIV-1-infection; COVID-19

Outcome Measures

Primary Outcomes (11)

• Number of Composite Primary End Point (Critical Care Admission, Palliative Discharge When Discharged From Hospital, or Mortality Within the 6 Weeks After Diagnosis of COVID-19) Events

  The primary endpoint is a composite of the number of critical care admission (high dependency unit or intensive care unit), mortality in hospital or palliative discharge when discharged from hospital, or mortality at 6 weeks after diagnosis of COVID-19 or at discharge from hospital (where applicable) events. Time-to-event methods, including Kaplan-Meier survival curves and Cox proportional-hazards models, will be used for this analysis. The time to the primary endpoints will be defined as: * For participants admitted to critical care Time = \[Date of Critical care admission - Date of positive PCR test for COVID-19\] + 1 * For participants admitted to critical care before diagnosis of COVID-19, Time=1 day. * For participants with palliative discharge when discharged from hospital Time = \[Date of discharge from hospital to palliative care - Date of positive PCR test for COVID-19\] + 1. * For participants died Time = \[Date of death - Date of positive PCR test for COVID-19\] + 1.

  From baseline (diagnosis of COVID-19) to Week 6

• Kaplan-Meier Estimate of Primary End Point

  Kaplan-Meier estimate of the composite number of critical care admission, palliative discharge and death events

  From Baseline (diagnosis of COVID-19 ) to week 6

• Number of Palliative Discharge

  Number of palliative discharge at discharge from hospital following hospitalisation for COVID-19 events

  Baseline (diagnosis of COVID-19) to week 6

• Mortality

  Mortality at 6 weeks after diagnosis of COVID-19 or at discharge from hospital

  Baseline (diagnosis of COVID-19) to week 6

• Number of Critical Care Admission Events

  Number of admission events to a high dependency unit or intensive care unit

  Baseline (diagnosis of COVID-19) to week 6

• HIV Viral Load

  Identification of risk factors for COVID-19 infection within the group of PLHIV: HIV viral load

  Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)

• Time Since HIV Diagnosis

  Identification of risk factors for COVID-19 infection within the group of PLHIV: Time since HIV diagnosis

  Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)

• Chronic Obstructive Pulmonary Disease

  Identification of risk factors for COVID-19 infection within the group of PLHIV: Chronic Obstructive Pulmonary Disease

  Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)

• CD4 Cell Count

  Identification of risk factors for COVID-19 infection within the group of PLHIV: CD4 cell count

  Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)

• Chronic Kidney Disease

  Identification of risk factors for COVID-19 infection within the group of PLHIV: Chronic Kidney Disease

  Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)

• Body Weight

  Identification of risk factors for COVID-19 infection within the group of PLHIV: Body weight

  Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)

Secondary Outcomes (20)

• Number of Hospitalisation Events

  Baseline (diagnosis of COVID-19) to week 6

• Length of Hospital Stay

  Baseline (diagnosis of COVID-19) to week 6

• Length of Stay in ICU

  Baseline (diagnosis of COVID-19) to week 6

• Ventilator-free Days (VFDs)

  6 weeks after diagnosis of COVID-19

• Extracorporeal Membrane Oxygenation (ECMO)

  Baseline (diagnosis of COVID-19) to week 6

Study Arms (3)

PLWHIV with COVID-19 cases

Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.

Other: COVID-19; Other: HIV-1 infection

PLWHIV without COVID-19 controls

Patients at least 18 years of age with documented HIV-1 infection.

Other: HIV-1 infection

HIV seronegative patients with COVID-19 controls

Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.

Other: COVID-19

Interventions

COVID-19 OTHER

Diagnosed with COVID-19 infection

HIV seronegative patients with COVID-19 controls; PLWHIV with COVID-19 cases

HIV-1 infection OTHER

Diagnosed with HIV-1 infection

PLWHIV with COVID-19 cases; PLWHIV without COVID-19 controls

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 study population will consist of adult PLWHIV with and without COVID-19 disease, followed up at the study sites for routine clinical care. Data from adult COVID-19 patients without HIV infection will be used as controls. 500 cases (PLWHIV + COVID-19) will be recruited. These patients will be at least 18 years old with documented HIV-1 infection and SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021. 500 COVID-19 controls will be recruited. These patients will be at least 18 years old without documented HIV-1 infection but confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021. 1000 PLWHIV control patients will be recruited for the second control group. This group will include individuals at least 18 years old with documented HIV-1 infection.

You may qualify if:

• Cases (PLWHIV + COVID-19)
• Any gender
• At least 18 years of age
• Documented HIV-1 infection
• Confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021
• Controls (COVID-19)
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• Any gender
• At least 18 years of age
• No documented HIV-1 infection
• Confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021
• Meet the matching criteria
• For comparing PLWHIV \& COVID-19 versus HIV seronegative COVID-19 patients, a 1:1 matching will be performed according to the following criteria:
• Age (+/- 5 years)
• Sex

You may not qualify if:

• For cases (PLWHIV + COVID-19) and for COVID-19 only controls:
• COVID-19 diagnosed based on clinical criteria

Sponsors & Collaborators

• NEAT ID Foundation: lead
• Gilead Sciences: collaborator

Study Sites (23)

CHU Saint Pierre

Brussels, Belgium

Location

Hôpital Européen Marseille

Marseille, France

Location

Hôpital Saint Louis

Paris, France

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Hospital Clinic Barcelona

Barcelona, Spain

Location

Hospital de la Santa Creu I Sant Pau

Barcelona, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, Spain

Location

Hospital Universitario Basurto

Bilbao, Spain

Location

Hospital General Universitario de Elche

Elche, Spain

Location

Hospital Universitario San Pedro

Logroño, Spain

Location

Hospital Ramón y Cajal

Madrid, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain

Location

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, United Kingdom

Location

Southmead Hospital (North Bristol)

Bristol, United Kingdom

Location

University Hospitals of Derby & Burton NHS Foundation Trust

Derby, United Kingdom

Location

Brownlee Centre, Gartnavel General Hospital

Glasgow, United Kingdom

Location

Barts Health (The Royal London Hospital)

London, United Kingdom

Location

Chelsea & Westminster Hospital NHS Foundation Trust

London, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

There are two analysis groups: exposed/unexposed (HIV+COVID-19+ and HIV-COVID-19+) and case-control (HIV+COVID-19+ and HIV+COVID-19-). There are limitations in data availability as this is a retrospective data collection study and all variables could not be collected for all participants. Multiple imputation using Chained Equations approach (MICE) was used to fill in missing data.

Results Point of Contact

• Title: HIV COCO Project Manager
• Organization: Research Organization (KC) Ltd

hivcoco@rokcservices.com

+44 (0) 7494 795 982

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 1, 2022
• Study Start: March 29, 2022
• Primary Completion: March 31, 2023
• Study Completion: August 31, 2023
• Last Updated: March 24, 2025
• Results First Posted: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10); BE (1); FR (2); GB (9); NL (1)