HIV-1 & Coronavirus-Coinfection in Europe: Morbidity & Risk Factors of COVID-19 in People Living With HIV
- Conditions
- HIV-1-infectionCOVID-19
- Interventions
- Other: COVID-19Other: HIV-1 infection
- Registration Number
- NCT05481216
- Lead Sponsor
- NEAT ID Foundation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2598
-
• Cases (PLWHIV + COVID-19)
-
Any gender
-
At least 18 years of age
-
Documented HIV-1 infection
-
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)
- Any gender
- At least 18 years of age
- No documented HIV-1 infection
- 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
- 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)
- Any gender
- At least 18 years of age
- Documented HIV-1 infection
- No evidence of SARS-CoV-2 infection
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PLWHIV with COVID-19 cases HIV-1 infection 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. HIV seronegative patients with COVID-19 controls COVID-19 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. PLWHIV with COVID-19 cases COVID-19 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. PLWHIV without COVID-19 controls HIV-1 infection Patients at least 18 years of age with documented HIV-1 infection.
- Primary Outcome Measures
Name Time Method 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 From baseline (diagnosis of COVID-19) to Week 6 The primary endpoint is a composite of the number of critical care admission (high dependency unit or intensive care unit), mortality in hospital or palliative discharge when discharged from hospital, or mortality at 6 weeks after diagnosis of COVID-19 or at discharge from hospital (where applicable) events. Time-to-event methods, including Kaplan-Meier survival curves and Cox proportional-hazards models, will be used for this analysis. The time to the primary endpoints will be defined as:
* For participants admitted to critical care Time = \[Date of Critical care admission - Date of positive PCR test for COVID-19\] + 1
* For participants admitted to critical care before diagnosis of COVID-19, Time=1 day.
* For participants with palliative discharge when discharged from hospital Time = \[Date of discharge from hospital to palliative care - Date of positive PCR test for COVID-19\] + 1.
* For participants died Time = \[Date of death - Date of positive PCR test for COVID-19\] + 1.Kaplan-Meier Estimate of Primary End Point From Baseline (diagnosis of COVID-19 ) to week 6 Kaplan-Meier estimate of the composite number of critical care admission, palliative discharge and death events
Number of Palliative Discharge Baseline (diagnosis of COVID-19) to week 6 Number of palliative discharge at discharge from hospital following hospitalisation for COVID-19 events
Mortality Baseline (diagnosis of COVID-19) to week 6 Mortality at 6 weeks after diagnosis of COVID-19 or at discharge from hospital
Number of Critical Care Admission Events Baseline (diagnosis of COVID-19) to week 6 Number of admission events to a high dependency unit or intensive care unit
HIV Viral Load Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19) Identification of risk factors for COVID-19 infection within the group of PLHIV: HIV viral load
Time Since HIV Diagnosis Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19) Identification of risk factors for COVID-19 infection within the group of PLHIV: Time since HIV diagnosis
Chronic Obstructive Pulmonary Disease Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19) Identification of risk factors for COVID-19 infection within the group of PLHIV: Chronic Obstructive Pulmonary Disease
CD4 Cell Count Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19) Identification of risk factors for COVID-19 infection within the group of PLHIV: CD4 cell count
Chronic Kidney Disease Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19) Identification of risk factors for COVID-19 infection within the group of PLHIV: Chronic Kidney Disease
Body Weight Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19) Identification of risk factors for COVID-19 infection within the group of PLHIV: Body weight
- Secondary Outcome Measures
Name Time Method Number of Hospitalisation Events Baseline (diagnosis of COVID-19) to week 6 Number of hospital admission for COVID-19 events
Length of Hospital Stay Baseline (diagnosis of COVID-19) to week 6 Length of stay in hospital following hospitalisation for COVID-19
Length of Stay in ICU Baseline (diagnosis of COVID-19) to week 6 Median Length of Stay in Intensive Care Unit
Ventilator-free Days (VFDs) 6 weeks after diagnosis of COVID-19 Number of ventilator-free days
Extracorporeal Membrane Oxygenation (ECMO) Baseline (diagnosis of COVID-19) to week 6 Length of extracorporeal membrane oxygenation
Need for Kidney Replacement Therapy Baseline(diagnosis of COVID-19) to week 6 The number of patients requiring kidney replacement therapy
Measurement of Total Comorbidity Burden 6 weeks after diagnosis of COVID-19 Charlson Comorbidity Index predicts the ten-year mortality for a patient who may have a range of comorbid conditions. Index consists of 19 conditions, each with an assigned weight from 1 to 6 according to the relative risk of dying. The total score is derived by summing up the weights of comorbid conditions presented. Based on the CCI score, the severity of comorbidity was categorized into three grades: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores ≥5. The minimum score value is 0 and maximum is 37. A higher score means a more greater mortality risk.
Estimate Risk of 30-day Mortality After COVID-19 Infection Baseline (diagnosis of COVID-19) to week 6 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). The VACO index is expressed as a percentage and calculated based on age, sex, Charlson comorbidity index (CCI), and the presence of myocardial infarction (MI) or peripheral vascular disease (PVD). The index range is from 0.2 to 48.0. A higher score means a greater risk of mortality.
Blood Cell Counts at COVID-19 Diagnosis Baseline (Diagnosis of COVID-19) The endpoint is the blood cell counts at COVID-19 diagnosis. The analyses will be performed with all PLHIV with COVID-19 and matched HIV-uninfected individual with COVID-19 who have data regarding the blood cell count of interest at COVID-19 diagnosis
Liver Function and Tissue Damage Parameters at COVID-19 Diagnosis Baseline(COVID-19 diagnosis) The endpoint is the liver function (ALT, AST) and tissue damage (lactate dehydrogenase) parameters at COVID-19 diagnosis.
Inflammatory Markers and Kidney Function Tests Baseline (COVID-19 Diagnosis) Inflammatory markers and Kidney Function tests at COVID-19 diagnosis
Biological Parameters at COVID-19 Diagnosis Baseline(COVID-19 diagnosis) Biological parameters (D-dimer and Ferritin levels) at COVID-19 diagnosis
Cholesterol, Triglyceride and Glucose Levels Baseline(COVID-19 diagnosis) Cholesterol, Triglyceride and Glucose levels at COVID-19 diagnosis
Red Blood Cell Count Baseline(COVID-19 Diagnosis) Red blood cell (RBC) count at COVID-19 Diagnosis
Haemoglobin Levels Baseline(COVID-19 diagnosis) Haemoglobin levels at COVID-19 diagnosis
Haematocrit Baseline (COVID-19 diagnosis) Haematocrit levels at COVID-19 diagnosis
MCV Levels Baseline(COVID-19 diagnosis) Mean Corpuscular volume (MCV) levels at COVID-19 diagnosis
MCH Levels Baseline(COVID-19 diagnosis) Mean Corpuscular Haemoglobin levels at COVID-19 diagnosis
HbA1C Levels Baseline(COVID-19 diagnosis) Glycated Haemoglobin (HbA1C) levels at COVID-19 diagnosis
C-reactive Protein Levels Baseline(COVID-19 diagnosis) C-reactive protein levels at COVID-19 diagnosis
Trial Locations
- Locations (23)
CHU Saint Pierre
🇧🇪Brussels, Belgium
Hôpital Européen Marseille
🇫🇷Marseille, France
Hôpital Saint Louis
🇫🇷Paris, France
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
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Hospital Clinic Barcelona
🇪🇸Barcelona, 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