Prospective Observational Study for Patients With HIV and Confirmed SARS-CoV-2
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 412
- Locations
- 1
- Primary Endpoint
- Mortality
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Outcomes
Primary Outcomes
Mortality
Time Frame: 30 days
COVID-19 related death among patients with HIV and COVID-19
Secondary Outcomes
- Frequency of kidney injury(30 days)
- Frequency of patients requiring hospital admissions(30 days)
- Frequency of liver injury(30 days)
- Frequency of patients requiring ICU admissions(30 days)
- Frequency of respiratory support use(30 days)
Investigators
Dima Dandachi
Assistant Professor of Clinical Medicine
University of Missouri-Columbia