COVID-19 in Patients With HIV

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04333953
• Other study ID #: 2021341
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: March 28, 2022

Study information

• Verified date: May 2022
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 412
• Est. completion date: March 28, 2022
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• HIV/AIDS
• SARS-CoV-2

Intervention

Other:
• No intervention
No intervention, observational study

Locations

Country	Name	City	State
United States	University of Missouri-Columbia	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	COVID-19 related death among patients with HIV and COVID-19	30 days
Secondary	Frequency of patients requiring hospital admissions	Percentage of patients who required hospitalization	30 days
Secondary	Frequency of patients requiring ICU admissions	Percentage of patients who required ICU admission	30 days
Secondary	Frequency of respiratory support use	Percentage of patients who required respiratory support (new oxygen use, non-invasive ventilation,or invasive ventilation)	30 days
Secondary	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
Secondary	Frequency of liver injury	Percentage of patients who developed liver injury defined as increase in baseline ALT	30 days