COVID-19 in Patients With HIV

Study Overview
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Brief Summary
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Currently, limited data is available about patients with HIV in the context of the COVID-19 pandemic. People with HIV who have not achieved viral suppression through antiretroviral treatment may have a compromised immune system that leaves them vulnerable to infections and disease progression. However, little is known about the presentation and clinical outcomes of patients with HIV and SARS-CoV-2. Our aim is to characterize the clinical presentation and disease course of COVID-19 in patients with HIV.

Detailed Description
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Currently, limited data is available about patients with HIV in the context of the COVID-19 pandemic. People with HIV (PWH)/AIDS, or people with HIV who have not achieved viral suppression through antiretroviral treatment may have at higher risk for SARS-CoV-2 infections and disease progression. At present there is no evidence to suggest that there is an increased risk of infection and increased severity of illness for PWH. We know that during the SARS and MERS outbreaks, there were only few case reports of mild disease among PWH. Current clinical data suggest the main mortality risk factors are linked to older age and other co-morbidities. However, some healthy people have also developed severe disease from the SARS-CoV-2 infection. This is a multi-center prospective observational study. Our aim is to characterize the clinical presentation and clinical course of COVID-19 in patients with HIV. Patients with HIV and confirmed SARS-Cov-2 will be identified during routine clinical care in the inpatient or outpatient setting. Contributors will share de-identified demographic data, health history data, and clinical data pertaining the patient's presentation with COVID-19 and outcomes obtained during routine care for their patients, using the secure online data collection tool REDCap.

Official Title
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Prospective Observational Study for Patients With HIV and Confirmed SARS-CoV-2

Conditions
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HIV/AIDS, COVID-19, SARS-CoV-2

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV disease Laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay Exclusion Criteria: None
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

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention, observational study|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | COVID-19 related death among patients with HIV and COVID-19 | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of patients requiring hospital admissions | Percentage of patients who required hospitalization | 30 days | 
| Frequency of patients requiring ICU admissions | Percentage of patients who required ICU admission | 30 days | 
| Frequency of respiratory support use | Percentage of patients who required respiratory support (new oxygen use, non-invasive ventilation,or invasive ventilation) | 30 days | 
| Frequency of kidney injury | Percentage of patients who developed acute kidney injury defined as increase in baseline creatinine, or use of renal replacement therapy | 30 days | 
| Frequency of liver injury | Percentage of patients who developed liver injury defined as increase in baseline ALT | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, AIDS, COVID-19, SARS-CoV-2, clinical presentation, progression, clinical outcome