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

COVID-19 in Patients With HIV

Sponsors

Lead sponsor: University of Missouri-Columbia

Source 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.

Overall Status Recruiting
Start Date April 1, 2020
Completion Date October 1, 2020
Primary Completion Date October 1, 2020
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Mortality 30 days
Secondary Outcome
Measure Time Frame
Frequency of patients requiring hospital admissions 30 days
Frequency of patients requiring ICU admissions 30 days
Frequency of respiratory support use 30 days
Frequency of kidney injury 30 days
Frequency of liver injury 30 days
Enrollment 500
Condition
Intervention

Intervention type: Other

Intervention name: No intervention

Description: No intervention, observational study

Eligibility

Sampling method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Location
facility status contact University of Missouri-Columbia Dima Dandachi, MD 573-884-8728 [email protected]
Location Countries

United States

Verification Date

April 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Missouri-Columbia

Investigator full name: Dima Dandachi

Investigator title: Assistant Professor of Clinical Medicine

Keywords
Has Expanded Access No
Patient Data Undecided
Study Design Info

Observational model: Case-Only

Time perspective: Prospective

Source: ClinicalTrials.gov