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COVID-19 in Patients With HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04333953
Recruitment Status : Completed
First Posted : April 3, 2020
Last Update Posted : May 23, 2022
Sponsor:
Information provided by (Responsible Party):
Dima Dandachi, University of Missouri-Columbia

Study Description
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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.


Condition or disease Intervention/treatment
HIV/AIDS COVID-19 SARS-CoV-2 Other: No intervention

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.

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 412 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
Actual Study Start Date : April 1, 2020
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : March 28, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: No intervention
    No intervention, observational study

Outcome Measures
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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


Eligibility Criteria
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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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Missouri
University of Missouri-Columbia
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dima Dandachi, Assistant Professor of Clinical Medicine, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT04333953    
Other Study ID Numbers: 2021341
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: May 23, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dima Dandachi, University of Missouri-Columbia:
HIV
AIDS
COVID-19
SARS-CoV-2
 clinical presentation
progression
clinical outcome
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases