HIV-1 & Coronavirus-Coinfection in Europe: Morbidity & Risk Factors of COVID-19 in People Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,598
- 试验地点
- 23
- 主要终点
- 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
研究概览
简要总结
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:
- Is there a particular risk for COVID-19 in PLWHIV as compared to HIV seronegative control COVID-19 cases?
- 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:
- Describe the differences in the clinical manifestation of COVID-19 in PLWHIV compared to HIV seronegative controls
- Describe the response to treatment, including supportive care and novel therapies against COVID-19, including antiviral or immunomodulatory therapy
- Describe the co-morbidities in PLWHIV and controls with COVID-19
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Cases (PLWHIV + COVID-19)
- •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)
- •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)
- •Ethnicity (where available)
- •Month of COVID-19 diagnosis (+/- 2 months)
- •COVID-19 diagnosis inpatient OR
- •COVID-19 diagnosis outpatient (ambulatory)
- •Controls (PLWHIV)
- •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)
- •Ethnicity (where available)
- •Exclusion Criteria
- •For cases (PLWHIV + COVID-19) and for COVID-19 only controls:
- •COVID-19 diagnosed based on clinical criteria
排除标准
- 未提供
结局指标
主要结局
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
时间窗: 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
时间窗: 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
时间窗: Baseline (diagnosis of COVID-19) to week 6
Number of palliative discharge at discharge from hospital following hospitalisation for COVID-19 events
Mortality
时间窗: 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
时间窗: Baseline (diagnosis of COVID-19) to week 6
Number of admission events to a high dependency unit or intensive care unit
HIV Viral Load
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- Number of Hospitalisation Events(Baseline (diagnosis of COVID-19) to week 6)
- Length of Hospital Stay(Baseline (diagnosis of COVID-19) to week 6)
- Length of Stay in ICU(Baseline (diagnosis of COVID-19) to week 6)
- Ventilator-free Days (VFDs)(6 weeks after diagnosis of COVID-19)
- Extracorporeal Membrane Oxygenation (ECMO)(Baseline (diagnosis of COVID-19) to week 6)
- Need for Kidney Replacement Therapy(Baseline(diagnosis of COVID-19) to week 6)
- Measurement of Total Comorbidity Burden(6 weeks after diagnosis of COVID-19)
- Estimate Risk of 30-day Mortality After COVID-19 Infection(Baseline (diagnosis of COVID-19) to week 6)
- Blood Cell Counts at COVID-19 Diagnosis(Baseline (Diagnosis of COVID-19))
- Liver Function and Tissue Damage Parameters at COVID-19 Diagnosis(Baseline(COVID-19 diagnosis))
- Inflammatory Markers and Kidney Function Tests(Baseline (COVID-19 Diagnosis))
- Biological Parameters at COVID-19 Diagnosis(Baseline(COVID-19 diagnosis))
- Cholesterol, Triglyceride and Glucose Levels(Baseline(COVID-19 diagnosis))
- Red Blood Cell Count(Baseline(COVID-19 Diagnosis))
- Haemoglobin Levels(Baseline(COVID-19 diagnosis))
- Haematocrit(Baseline (COVID-19 diagnosis))
- MCV Levels(Baseline(COVID-19 diagnosis))
- MCH Levels(Baseline(COVID-19 diagnosis))
- HbA1C Levels(Baseline(COVID-19 diagnosis))
- C-reactive Protein Levels(Baseline(COVID-19 diagnosis))