CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,598 enrolled
Drug / intervention
COVID-19 +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05481216
NCT05481216N/ACompleted

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

NEAT ID Foundation·observational·Posted Aug 1, 2022·Updated Mar 24, 2025

In Brief

An observational study evaluating COVID-19 and HIV-1 infection for HIV-1-infection and COVID-19. Completed, enrolled 2,598 participants across 23 sites in 5 countries.

Detailed 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. 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 Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, France, Netherlands, Spain, United Kingdom
CollaboratorsGilead Sciences

Timeline

N/ACompletedFinished
2023202420252026
First PostedAug 1, 2022
Enrollment StartMar 29, 2022
Primary CompletionMar 31, 2023
Study CompletionAug 31, 2023
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 3.9 years ago

Interventions

COVID-19other

Diagnosed with COVID-19 infection

HIV-1 infectionother

Diagnosed with HIV-1 infection