HIV-1 & Coronavirus-Coinfection in Europe: Morbidity & Risk Factors of COVID-19 in People Living With HIV
NCT ID: NCT05481216
Last Updated: 2025-03-24
Study Results
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View full resultsBasic Information
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COMPLETED
2598 participants
OBSERVATIONAL
2022-03-29
2023-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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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.
COVID-19
Diagnosed with COVID-19 infection
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.
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.
COVID-19
Diagnosed with COVID-19 infection
Interventions
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COVID-19
Diagnosed with COVID-19 infection
HIV-1 infection
Diagnosed with HIV-1 infection
Eligibility Criteria
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Inclusion Criteria
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)
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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
* COVID-19 diagnosed based on clinical criteria
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
NEAT ID Foundation
OTHER
Responsible Party
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Locations
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CHU Saint Pierre
Brussels, , Belgium
Hôpital Européen Marseille
Marseille, , France
Hôpital Saint Louis
Paris, , France
Erasmus Medical Center
Rotterdam, , Netherlands
Hospital Clinic Barcelona
Barcelona, , Spain
Hospital de la Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Universitari de Bellvitge
Barcelona, , Spain
Hospital Universitario Basurto
Bilbao, , Spain
Hospital General Universitario de Elche
Elche, , Spain
Hospital Universitario San Pedro
Logroño, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, , Spain
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, , United Kingdom
Southmead Hospital (North Bristol)
Bristol, , United Kingdom
University Hospitals of Derby & Burton NHS Foundation Trust
Derby, , United Kingdom
Brownlee Centre, Gartnavel General Hospital
Glasgow, , United Kingdom
Barts Health (The Royal London Hospital)
London, , United Kingdom
Chelsea & Westminster Hospital NHS Foundation Trust
London, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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303CoCo
Identifier Type: -
Identifier Source: org_study_id
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