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

COVID-19 Clinical Trial

— HIV CoCo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05481216
• Other study ID #: 303CoCo
• Status: Completed
• Start date: March 29, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: September 2023
• Source: NEAT ID Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2598
• Est. completion date: August 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coinfection
• COVID-19
• HIV-1-infection

Intervention

Other:
• COVID-19
Diagnosed with COVID-19 infection
• HIV-1 infection
Diagnosed with HIV-1 infection

Locations

Country	Name	City	State
Belgium	CHU Saint Pierre	Brussels
France	Hôpital Européen Marseille	Marseille
France	Hôpital Saint Louis	Paris
Germany	Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH	Berlin
Germany	University Hospital Bonn	Bonn
Germany	Praxis am Ebertplatz	Köln
Germany	University Hospital Rechts der Isar	Munich
Greece	"Korgialenio-Benakio" Red Cross General Hospital	Athens
Italy	Santa Maria della Misericordia	Rovigo
Netherlands	Erasmus Medical Center	Rotterdam
Spain	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
United Kingdom	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

Sponsors (2)

Lead Sponsor	Collaborator
NEAT ID Foundation	Gilead Sciences

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Greece,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Critical care admission	Admission to a high dependency unit or intensive care unit	Within 6 weeks after diagnosis of COVID-19
Primary	Mortality in hospital or palliative discharge at discharge from hospital	Mortality	Within 6 weeks after diagnosis of COVID-19
Primary	Mortality at 6 weeks after diagnosis of COVID-19 or at discharge from hospital	Where applicable	6 weeks after diagnosis of COVID-19
Secondary	Hospitalisation for COVID-19	Admission to hospital	Within 6 weeks after diagnosis of COVID-19
Secondary	Length of stay in hospital	Length of stay	6 weeks after diagnosis of COVID-19
Secondary	Length of stay in ICU	Intensive Care Unit	6 weeks after diagnosis of COVID-19
Secondary	Number of ventilator-free days (VFDs)	ventilator-free days	6 weeks after diagnosis of COVID-19
Secondary	Length of extracorporeal membrane oxygenation (ECMO)	extracorporeal membrane oxygenation	6 weeks after diagnosis of COVID-19
Secondary	The proportion of patients with the need for kidney replacement therapy	kidney replacement therapy	6 weeks after diagnosis of COVID-19
Secondary	Measurement of total comorbidity burden	Measured using the Charlson Comorbidity Index (CCI) and age-adjusted CCI (ACCI)	6 weeks after diagnosis of COVID-19
Secondary	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
Secondary	full blood cell counts at COVID-19 diagnosis	Inflammatory marker and blood cell counts	At COVID-19 diagnosis
Secondary	inflammatory marker count at COVID-19 diagnosis	inflammatory marker count at COVID-19 diagnosis	At COVID-19 diagnosis