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 Type
OBSERVATIONAL
Enrollment
2,598
Diagnosed with COVID-19 infection
Diagnosed with HIV-1 infection
CHU Saint Pierre
Brussels, Belgium
Hôpital Européen Marseille
Marseille, France
Hôpital Saint Louis
Paris, France
Erasmus Medical Center
Rotterdam, Netherlands
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
...and 13 more locations
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
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.
Time frame: From baseline (diagnosis of COVID-19) to Week 6
Kaplan-Meier Estimate of Primary End Point
Kaplan-Meier estimate of the composite number of critical care admission, palliative discharge and death events
Time frame: From Baseline (diagnosis of COVID-19 ) to week 6
Number of Palliative Discharge
Number of palliative discharge at discharge from hospital following hospitalisation for COVID-19 events
Time frame: Baseline (diagnosis of COVID-19) to week 6
Mortality
Mortality at 6 weeks after diagnosis of COVID-19 or at discharge from hospital
Time frame: Baseline (diagnosis of COVID-19) to week 6
Number of Critical Care Admission Events
Number of admission events to a high dependency unit or intensive care unit
Time frame: Baseline (diagnosis of COVID-19) to week 6
HIV Viral Load
Identification of risk factors for COVID-19 infection within the group of PLHIV: HIV viral load
Time frame: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)
Time Since HIV Diagnosis
Identification of risk factors for COVID-19 infection within the group of PLHIV: Time since HIV diagnosis
Time frame: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)
Chronic Obstructive Pulmonary Disease
Identification of risk factors for COVID-19 infection within the group of PLHIV: Chronic Obstructive Pulmonary Disease
Time frame: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)
CD4 Cell Count
Identification of risk factors for COVID-19 infection within the group of PLHIV: CD4 cell count
Time frame: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)
Chronic Kidney Disease
Identification of risk factors for COVID-19 infection within the group of PLHIV: Chronic Kidney Disease
Time frame: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)
Body Weight
Identification of risk factors for COVID-19 infection within the group of PLHIV: Body weight
Time frame: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)
Number of Hospitalisation Events
Number of hospital admission for COVID-19 events
Time frame: Baseline (diagnosis of COVID-19) to week 6
Length of Hospital Stay
Length of stay in hospital following hospitalisation for COVID-19
Time frame: Baseline (diagnosis of COVID-19) to week 6
Length of Stay in ICU
Median Length of Stay in Intensive Care Unit
Time frame: Baseline (diagnosis of COVID-19) to week 6
Ventilator-free Days (VFDs)
Number of ventilator-free days
Time frame: 6 weeks after diagnosis of COVID-19
Extracorporeal Membrane Oxygenation (ECMO)
Length of extracorporeal membrane oxygenation
Time frame: Baseline (diagnosis of COVID-19) to week 6
Need for Kidney Replacement Therapy
The number of patients requiring kidney replacement therapy
Time frame: Baseline(diagnosis of COVID-19) to week 6
Measurement of Total Comorbidity Burden
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.
Time frame: 6 weeks after diagnosis of COVID-19
Estimate Risk of 30-day Mortality After COVID-19 Infection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: Baseline (diagnosis of COVID-19) to week 6
Blood Cell Counts at COVID-19 Diagnosis
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
Time frame: Baseline (Diagnosis of COVID-19)
Liver Function and Tissue Damage Parameters at COVID-19 Diagnosis
The endpoint is the liver function (ALT, AST) and tissue damage (lactate dehydrogenase) parameters at COVID-19 diagnosis.
Time frame: Baseline(COVID-19 diagnosis)
Inflammatory Markers and Kidney Function Tests
Inflammatory markers and Kidney Function tests at COVID-19 diagnosis
Time frame: Baseline (COVID-19 Diagnosis)
Biological Parameters at COVID-19 Diagnosis
Biological parameters (D-dimer and Ferritin levels) at COVID-19 diagnosis
Time frame: Baseline(COVID-19 diagnosis)
Cholesterol, Triglyceride and Glucose Levels
Cholesterol, Triglyceride and Glucose levels at COVID-19 diagnosis
Time frame: Baseline(COVID-19 diagnosis)
Red Blood Cell Count
Red blood cell (RBC) count at COVID-19 Diagnosis
Time frame: Baseline(COVID-19 Diagnosis)
Haemoglobin Levels
Haemoglobin levels at COVID-19 diagnosis
Time frame: Baseline(COVID-19 diagnosis)
Haematocrit
Haematocrit levels at COVID-19 diagnosis
Time frame: Baseline (COVID-19 diagnosis)
MCV Levels
Mean Corpuscular volume (MCV) levels at COVID-19 diagnosis
Time frame: Baseline(COVID-19 diagnosis)
MCH Levels
Mean Corpuscular Haemoglobin levels at COVID-19 diagnosis
Time frame: Baseline(COVID-19 diagnosis)
HbA1C Levels
Glycated Haemoglobin (HbA1C) levels at COVID-19 diagnosis
Time frame: Baseline(COVID-19 diagnosis)
C-reactive Protein Levels
C-reactive protein levels at COVID-19 diagnosis
Time frame: Baseline(COVID-19 diagnosis)