COVID-19 in Patients With HIV

Sponsor
University of Missouri-Columbia (Other)
Overall Status
Completed
CT.gov ID
NCT04333953
Collaborator
(none)
412
1
23.9
17.3

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational [Patient Registry]
Actual Enrollment :
412 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Prospective Observational Study for Patients With HIV and Confirmed SARS-CoV-2
Actual Study Start Date :
Apr 1, 2020
Actual Primary Completion Date :
Jul 1, 2020
Actual Study Completion Date :
Mar 28, 2022

Outcome Measures

Primary Outcome Measures

  1. Mortality [30 days]

    COVID-19 related death among patients with HIV and COVID-19

Secondary Outcome Measures

  1. Frequency of patients requiring hospital admissions [30 days]

    Percentage of patients who required hospitalization

  2. Frequency of patients requiring ICU admissions [30 days]

    Percentage of patients who required ICU admission

  3. Frequency of respiratory support use [30 days]

    Percentage of patients who required respiratory support (new oxygen use, non-invasive ventilation,or invasive ventilation)

  4. Frequency of kidney injury [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 [30 days]

    Percentage of patients who developed liver injury defined as increase in baseline ALT

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University of Missouri-Columbia Columbia Missouri United States 65212

Sponsors and Collaborators

  • University of Missouri-Columbia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dima Dandachi, Assistant Professor of Clinical Medicine, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT04333953
Other Study ID Numbers:
  • 2021341
First Posted:
Apr 3, 2020
Last Update Posted:
May 23, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dima Dandachi, Assistant Professor of Clinical Medicine, University of Missouri-Columbia
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 23, 2022