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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

Tracking Information
First Submitted Date March 31, 2020
First Posted Date April 3, 2020
Last Update Posted Date May 23, 2022
Actual Study Start Date April 1, 2020
Actual Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 1, 2020)		 Mortality [ Time Frame: 30 days ]
COVID-19 related death among patients with HIV and COVID-19
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 1, 2020)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title COVID-19 in Patients With HIV
Official Title Prospective Observational Study for Patients With HIV and Confirmed SARS-CoV-2
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 1 Month
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with HIV disease who are diagnosed with COVID-19, inpatient or outpatient
Condition
  • HIV/AIDS
  • COVID-19
  • SARS-CoV-2
Intervention Other: No intervention
No intervention, observational study
Study Groups/Cohorts Not Provided
Publications * Dandachi D, Geiger G, Montgomery MW, Karmen-Tuohy S, Golzy M, Antar AAR, Llibre JM, Camazine M, Diaz-De Santiago A, Carlucci PM, Zacharioudakis IM, Rahimian J, Wanjalla CN, Slim J, Arinze F, Kratz AMP, Jones JL, Patel SM, Kitchell E, Francis A, Ray M, Koren DE, Baddley JW, Hill B, Sax PE, Chow J. Characteristics, Comorbidities, and Outcomes in a Multicenter Registry of Patients With Human Immunodeficiency Virus and Coronavirus Disease 2019. Clin Infect Dis. 2021 Oct 5;73(7):e1964-e1972. doi: 10.1093/cid/ciaa1339.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 16, 2022)		 412
Original Estimated Enrollment
 (submitted: April 1, 2020)		 500
Actual Study Completion Date March 28, 2022
Actual Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04333953
Other Study ID Numbers 2021341
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Dima Dandachi, University of Missouri-Columbia
Original Responsible Party Same as current
Current Study Sponsor University of Missouri-Columbia
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Missouri-Columbia
Verification Date May 2022