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

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. Is there a particular risk for COVID-19 in PLWHIV as compared to HIV seronegative control COVID-19 cases?
2. Are there particular factors, within the group of PLWHIV, which put them at risk for a more severe COVID-19 disease course?

The study will address these questions by recruiting patients co-infected with both HIV and SARS-CoV-2 and comparing them to two control groups - one group infected with SARS-CoV-2 only and another group infected with HIV only. Only deidentified, real-world retrospective data will be used for the study, collected as part of standard, routine clinical care.

Additionally, this study will also look to:

1. Describe the differences in the clinical manifestation of COVID-19 in PLWHIV compared to HIV seronegative controls
2. Describe the response to treatment, including supportive care and novel therapies against COVID-19, including antiviral or immunomodulatory therapy
3. Describe the co-morbidities in PLWHIV and controls with COVID-19
4. Compare the severity of COVID-19 between PLWHIV and the COVID-19 only controls at diagnosis and hospital admission.

Data will be collected about patient outcomes from COVID-19 (including hospitalisation for COVID-19, length of stay in hospital, critical care admission, ventilation/oxygenation requirements, and need for kidney replacement therapy), as well as pre-existing health conditions, and relevant blood results at COVID-19 diagnosis.

Study Overview

• Status: Completed
• Conditions: COVID-19; HIV-1-infection
• Intervention / Treatment: Other: COVID-19; Other: HIV-1 infection

• Study Type: Observational
• Enrollment (Actual): 2598

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • CHU Saint Pierre
• France
  • Marseille, France
    • Hopital européen Marseille
  • Paris, France
    • Hopital Saint Louis
• Germany
  • Berlin, Germany
    • Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH
  • Bonn, Germany
    • University Hospital Bonn
  • Köln, Germany
    • Praxis am Ebertplatz
  • Munich, Germany
    • University Hospital Rechts der Isar
• Greece
  • Athens, Greece
    • "Korgialenio-Benakio" Red Cross General Hospital
• Italy
  • Rovigo, Italy
    • Santa Maria della Misericordia
• Netherlands
  • Rotterdam, Netherlands
    • Erasmus Medical Center
• Spain
  • Barcelona, Spain
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain
    • Hospital Universitari de Bellvitge
  • Barcelona, Spain
    • Hospital Clinic Barcelona
  • Bilbao, Spain
    • Hospital Universitario Basurto
  • Elche, Spain
    • Hospital General Universitario de Elche
  • Logroño, Spain
    • Hospital Universitario San Pedro
  • Madrid, Spain
    • Hospital Ramón y Cajal
  • Madrid, Spain
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Majadahonda, Spain
    • Hospital Universitario Puerta de Hierro Majadahonda
• United Kingdom
  • Bradford, United Kingdom
    • Bradford Teaching Hospitals NHS Foundation Trust
  • Bristol, United Kingdom
    • Southmead Hospital (North Bristol)
  • Derby, United Kingdom
    • University Hospitals of Derby & Burton NHS Foundation Trust
  • Glasgow, United Kingdom
    • Brownlee Centre, Gartnavel General Hospital
  • London, United Kingdom
    • Royal Free London NHS Foundation Trust
  • London, United Kingdom
    • King's College Hospital NHS Foundation Trust
  • London, United Kingdom
    • Guy's and St Thomas' NHS Foundation Trust
  • London, United Kingdom
    • Chelsea & Westminster Hospital NHS Foundation Trust
  • London, United Kingdom
    • Barts Health (The Royal London Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• • Cases (PLWHIV + COVID-19)

  1. Any gender
  2. At least 18 years of age
  3. Documented HIV-1 infection

  4. 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)
  1. Any gender
  2. At least 18 years of age
  3. No documented HIV-1 infection
  4. 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
  5. 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
• Ethnicity (where available)
• Month of COVID-19 diagnosis (+/- 2 months)
• COVID-19 diagnosis inpatient OR
• COVID-19 diagnosis outpatient (ambulatory)

• Controls (PLWHIV)

  1. Any gender
  2. At least 18 years of age
  3. Documented HIV-1 infection
  4. No evidence of SARS-CoV-2 infection
  5. Meet the matching criteria

For comparing PLWHIV & COVID-19 versus PLWHIV without COVID-19, a 1:2 matching for similar risk of acquiring COVID-19 will be performed according to the following criteria:

• Age (+/- 5 years)
• Sex
• Ethnicity (where available)

Exclusion Criteria

For cases (PLWHIV + COVID-19) and for COVID-19 only controls:

• COVID-19 diagnosed based on clinical criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Diagnosed with COVID-19 infection; Other: HIV-1 infection; Diagnosed with HIV-1 infection
PLWHIV without COVID-19 controls; Patients at least 18 years of age with documented HIV-1 infection.	Other: HIV-1 infection; Diagnosed with 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; Diagnosed with COVID-19 infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Critical care admission	Admission to a high dependency unit or intensive care unit	Within 6 weeks after diagnosis of COVID-19
Mortality in hospital or palliative discharge at discharge from hospital	Mortality	Within 6 weeks after diagnosis of COVID-19
Mortality at 6 weeks after diagnosis of COVID-19 or at discharge from hospital	Where applicable	6 weeks after diagnosis of COVID-19

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalisation for COVID-19	Admission to hospital	Within 6 weeks after diagnosis of COVID-19
Length of stay in hospital	Length of stay	6 weeks after diagnosis of COVID-19
Length of stay in ICU	Intensive Care Unit	6 weeks after diagnosis of COVID-19
Number of ventilator-free days (VFDs)	ventilator-free days	6 weeks after diagnosis of COVID-19
Length of extracorporeal membrane oxygenation (ECMO)	extracorporeal membrane oxygenation	6 weeks after diagnosis of COVID-19
The proportion of patients with the need for kidney replacement therapy	kidney replacement therapy	6 weeks after diagnosis of COVID-19
Measurement of total comorbidity burden	Measured using the Charlson Comorbidity Index (CCI) and age-adjusted CCI (ACCI)	6 weeks after diagnosis of COVID-19
Estimate risk of 30-day mortality after COVID-19 infection using pre-COVID health status	Estimated using the Veterans Health Administration COVID-19 (VACO) index	6 weeks after diagnosis of COVID-19
full blood cell counts at COVID-19 diagnosis	Inflammatory marker and blood cell counts	At COVID-19 diagnosis
inflammatory marker count at COVID-19 diagnosis	inflammatory marker count at COVID-19 diagnosis	At COVID-19 diagnosis

Collaborators and Investigators

• Sponsor: NEAT ID Foundation
• Collaborators: Gilead Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: July 29, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coinfection
• Other Study ID Numbers: 303CoCo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only anonymised summary-format data will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No