COVID-19 in Patients With HIV

Completed

• Conditions: HIV/AIDS; SARS-CoV-2; COVID-19

• Registration Number: NCT04333953
• Lead Sponsor: University of Missouri-Columbia

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 Timeline

• Study First Submitted: 2020-03-31
• Study Start: 2020-04-01
• Study First Submitted QC: 2020-04-01
• Study First Posted: 2020-04-03
• Primary Completion: 2020-07-01
• Study Completion: 2022-03-28
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 412

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	30 days	COVID-19 related death among patients with HIV and COVID-19

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Missouri-Columbia; 🇺🇸 Columbia, Missouri, United States