Clinical trial NCT05481216: HIV-1 & Coronavirus-Coinfection in Europe: Morbidity & Risk Factors of COVID-19 in People Living With HIV
Official title: HIV-1 & Coronavirus-Coinfection in Europe: Morbidity & Risk Factors of COVID-19 in People Living With HIV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1-infection
COVID-19
Lead sponsor: NEAT ID Foundation
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2022-08-01
Enrollment: 2598
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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)

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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

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

* COVID-19 diagnosed based on clinical criteria

Primary outcomes:
measure: Number of Composite Primary End Point (Critical Care Admission, Palliative Discharge When Discharged From Hospital, or Mortality Within the 6 Weeks After Diagnosis of COVID-19) Events
timeFrame: From baseline (diagnosis of COVID-19) to Week 6
measure: Kaplan-Meier Estimate of Primary End Point
timeFrame: From Baseline (diagnosis of COVID-19 ) to week 6
measure: Number of Palliative Discharge
timeFrame: Baseline (diagnosis of COVID-19) to week 6
measure: Mortality
timeFrame: Baseline (diagnosis of COVID-19) to week 6
measure: Number of Critical Care Admission Events
timeFrame: Baseline (diagnosis of COVID-19) to week 6
measure: HIV Viral Load
timeFrame: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)
measure: Time Since HIV Diagnosis
timeFrame: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)
measure: Chronic Obstructive Pulmonary Disease
timeFrame: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)
measure: CD4 Cell Count
timeFrame: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)
measure: Chronic Kidney Disease
timeFrame: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)
measure: Body Weight
timeFrame: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)
Secondary outcomes:
measure: Number of Hospitalisation Events
timeFrame: Baseline (diagnosis of COVID-19) to week 6
measure: Length of Hospital Stay
timeFrame: Baseline (diagnosis of COVID-19) to week 6
measure: Length of Stay in ICU
timeFrame: Baseline (diagnosis of COVID-19) to week 6
measure: Ventilator-free Days (VFDs)
timeFrame: 6 weeks after diagnosis of COVID-19
measure: Extracorporeal Membrane Oxygenation (ECMO)
timeFrame: Baseline (diagnosis of COVID-19) to week 6
measure: Need for Kidney Replacement Therapy
timeFrame: Baseline(diagnosis of COVID-19) to week 6
measure: Measurement of Total Comorbidity Burden
timeFrame: 6 weeks after diagnosis of COVID-19
measure: Estimate Risk of 30-day Mortality After COVID-19 Infection
timeFrame: Baseline (diagnosis of COVID-19) to week 6
measure: Blood Cell Counts at COVID-19 Diagnosis
timeFrame: Baseline (Diagnosis of COVID-19)
measure: Liver Function and Tissue Damage Parameters at COVID-19 Diagnosis
timeFrame: Baseline(COVID-19 diagnosis)
measure: Inflammatory Markers and Kidney Function Tests
timeFrame: Baseline (COVID-19 Diagnosis)
measure: Biological Parameters at COVID-19 Diagnosis
timeFrame: Baseline(COVID-19 diagnosis)
measure: Cholesterol, Triglyceride and Glucose Levels
timeFrame: Baseline(COVID-19 diagnosis)
measure: Red Blood Cell Count
timeFrame: Baseline(COVID-19 Diagnosis)
measure: Haemoglobin Levels
timeFrame: Baseline(COVID-19 diagnosis)
measure: Haematocrit
timeFrame: Baseline (COVID-19 diagnosis)
measure: MCV Levels
timeFrame: Baseline(COVID-19 diagnosis)
measure: MCH Levels
timeFrame: Baseline(COVID-19 diagnosis)
measure: HbA1C Levels
timeFrame: Baseline(COVID-19 diagnosis)
measure: C-reactive Protein Levels
timeFrame: Baseline(COVID-19 diagnosis)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Saint Pierre
city: Marseille
country: France
facility: Hôpital Européen Marseille
city: Paris
country: France
facility: Hôpital Saint Louis
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Bilbao
country: Spain
facility: Hospital Universitario Basurto
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
city: Logroño
country: Spain
facility: Hospital Universitario San Pedro
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: Southmead Hospital (North Bristol)
city: Derby
country: United Kingdom
facility: University Hospitals of Derby & Burton NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: Brownlee Centre, Gartnavel General Hospital
city: London
country: United Kingdom
facility: Barts Health (The Royal London Hospital)
city: London
country: United Kingdom
facility: Chelsea & Westminster Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
Study officials:
References: