An observational study in HIV/AIDS, COVID-19 and SARS-CoV-2, sponsored by University of Missouri-Columbia. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2022-05-23.
Sponsored by University of Missouri-Columbia · Observational
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.
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.
2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.
This study's enrollment of 412 is above the median of 239 across 367 observational studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →University of Missouri-Columbia is the lead sponsor of 364 studies on the registry; 70 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 29 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with HIV disease who are diagnosed with COVID-19, inpatient or outpatient
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
No intervention, observational study
Mortality
COVID-19 related death among patients with HIV and COVID-19
Time frame: 30 days
Frequency of patients requiring hospital admissions
Percentage of patients who required hospitalization
Time frame: 30 days
Frequency of patients requiring ICU admissions
Percentage of patients who required ICU admission
Time frame: 30 days
Frequency of respiratory support use
Percentage of patients who required respiratory support (new oxygen use, non-invasive ventilation,or invasive ventilation)
Time frame: 30 days
Frequency of kidney injury
Percentage of patients who developed acute kidney injury defined as increase in baseline creatinine, or use of renal replacement therapy
Time frame: 30 days
Frequency of liver injury
Percentage of patients who developed liver injury defined as increase in baseline ALT
Time frame: 30 days
Plan to share: Undecided
Ran from Apr 2020 to primary completion in Jul 2020, 3 months.
Of 110 non-industry observational studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 132. This study's 3 months is below that.
Counting every sponsor, half of 125 studies reached it within 56 months; a quarter within 21 and three quarters within 127.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
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