Clinical trial NCT04333953: COVID-19 in Patients With HIV
Official title: Prospective Observational Study for Patients With HIV and Confirmed SARS-CoV-2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV/AIDS
COVID-19
SARS-CoV-2
Keywords: HIV
AIDS
COVID-19
SARS-CoV-2
clinical presentation
progression
clinical outcome
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 412
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HIV disease who are diagnosed with COVID-19, inpatient or outpatient

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.

Eligibility 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

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Frequency of patients requiring hospital admissions
timeFrame: 30 days
measure: Frequency of patients requiring ICU admissions
timeFrame: 30 days
measure: Frequency of respiratory support use
timeFrame: 30 days
measure: Frequency of kidney injury
timeFrame: 30 days
measure: Frequency of liver injury
timeFrame: 30 days
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
References:
citation: Dandachi D, Geiger G, Montgomery MW, Karmen-Tuohy S, Golzy M, Antar AAR, Llibre JM, Camazine M, Diaz-De Santiago A, Carlucci PM, Zacharioudakis IM, Rahimian J, Wanjalla CN, Slim J, Arinze F, Kratz AMP, Jones JL, Patel SM, Kitchell E, Francis A, Ray M, Koren DE, Baddley JW, Hill B, Sax PE, Chow J. Characteristics, Comorbidities, and Outcomes in a Multicenter Registry of Patients With Human Immunodeficiency Virus and Coronavirus Disease 2019. Clin Infect Dis. 2021 Oct 5;73(7):e1964-e1972. doi: 10.1093/cid/ciaa1339.