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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV-1-infection, COVID-19

Intervention / Treatment
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* Other: COVID-19
* Other: HIV-1 infection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PLWHIV with COVID-19 cases<br>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. | Other: COVID-19<br>* Diagnosed with COVID-19 infection<br>Other: HIV-1 infection<br>* Diagnosed with HIV-1 infection<br>|
| PLWHIV without COVID-19 controls<br>Patients at least 18 years of age with documented HIV-1 infection. | Other: HIV-1 infection<br>* Diagnosed with HIV-1 infection<br>|
| HIV seronegative patients with COVID-19 controls<br>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. | Other: COVID-19<br>* Diagnosed with COVID-19 infection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Critical care admission | Admission to a high dependency unit or intensive care unit | Within 6 weeks after diagnosis of COVID-19 | 
| Mortality in hospital or palliative discharge at discharge from hospital | Mortality | Within 6 weeks after diagnosis of COVID-19 | 
| Mortality at 6 weeks after diagnosis of COVID-19 or at discharge from hospital | Where applicable | 6 weeks after diagnosis of COVID-19 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalisation for COVID-19 | Admission to hospital | Within 6 weeks after diagnosis of COVID-19 | 
| Length of stay in hospital | Length of stay | 6 weeks after diagnosis of COVID-19 | 
| Length of stay in ICU | Intensive Care Unit | 6 weeks after diagnosis of COVID-19 | 
| Number of ventilator-free days (VFDs) | ventilator-free days | 6 weeks after diagnosis of COVID-19 | 
| Length of extracorporeal membrane oxygenation (ECMO) | extracorporeal membrane oxygenation | 6 weeks after diagnosis of COVID-19 | 
| The proportion of patients with the need for kidney replacement therapy | kidney replacement therapy | 6 weeks after diagnosis of COVID-19 | 
| Measurement of total comorbidity burden | Measured using the Charlson Comorbidity Index (CCI) and age-adjusted CCI (ACCI) | 6 weeks after diagnosis of COVID-19 | 
| 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 | 
| full blood cell counts at COVID-19 diagnosis | Inflammatory marker and blood cell counts | At COVID-19 diagnosis | 
| inflammatory marker count at COVID-19 diagnosis | inflammatory marker count at COVID-19 diagnosis | At COVID-19 diagnosis |