Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
Study NCT ID:
NCT05481216
Status:
COMPLETED
Last Update Posted:
2025-03-24
First Post:
2022-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
HIV-1 & Coronavirus-Coinfection in Europe: Morbidity & Risk Factors of COVID-19 in People Living With HIV
Sponsor:
NEAT ID Foundation
Organization:
Study Overview
Official Title:
HIV-1 & Coronavirus-Coinfection in Europe: Morbidity & Risk Factors of COVID-19 in People Living With HIV
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIV CoCo
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. 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: