COVID-19 in Patients With HIV
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|ClinicalTrials.gov Identifier: NCT04333953|
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : April 7, 2020
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.
|Condition or disease||Intervention/treatment|
|HIV/AIDS COVID-19 SARS-CoV-2||Other: No intervention|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|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|
- Other: No intervention
No intervention, observational study
- Mortality [ Time Frame: 30 days ]COVID-19 related death among patients with HIV and COVID-19
- Frequency of patients requiring hospital admissions [ Time Frame: 30 days ]Percentage of patients who required hospitalization
- Frequency of patients requiring ICU admissions [ Time Frame: 30 days ]Percentage of patients who required ICU admission
- 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)
- 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
- Frequency of liver injury [ Time Frame: 30 days ]Percentage of patients who developed liver injury defined as increase in baseline ALT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04333953
|United States, Missouri|
|University of Missouri-Columbia||Recruiting|
|Columbia, Missouri, United States, 65212|
|Contact: Dima Dandachi, MD 573-884-8728 firstname.lastname@example.org|