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COVID-19 in Patients With HIV - new study, database
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https://clinicaltrials.gov/ct2/show/NCT04333953
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.
Primary Outcome Measures :
1 Mortality [ Time Frame: 30 days ]COVID-19 related death among patients with HIV and COVID-19
Secondary Outcome Measures:
1 Frequency of patients requiring hospital admissions [ Time Frame: 30 days ]Percentage of patients who required hospitalization
2 Frequency of patients requiring ICU admissions [ Time Frame: 30 days ]Percentage of patients who required ICU admission
3 Frequency of respiratory support use [ Time Frame: 30 days ]Percentage of patients who required respiratory support (new oxygen use, non-invasive ventilation,or invasive ventilation)
4 Frequency of kidney injury [ Time Frame: 30 days ]Percentage of patients who developed acute kidney injury defined as increase in baseline creatinine, or use of renal replacement therapy
5 Frequency of liver injury [ Time Frame: 30 days ]Percentage of patients who developed liver injury defined as increase in baseline ALT
Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Prospective Observational Study for Patients With HIV and Confirmed SARS-CoV-2
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020
Ages Eligible for Study: Child, Adult, Older Adult
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
Study Population
Patients with HIV disease who are diagnosed with COVID-19, inpatient or outpatient
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
Locations
United States, Missouri
University of Missouri-Columbia Recruiting
Columbia, Missouri, United States, 65212
Contact: Dima Dandachi, MD 573-884-8728 dandachid"at"health.missouri.edu
Sponsors and Collaborators
University of Missouri-Columbia
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