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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
Sponsor:
Information provided by (Responsible Party):
Dima Dandachi, University of Missouri-Columbia

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 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
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS


Intervention Details:
  • Other: No intervention
    No intervention, observational study


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



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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

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 Recruiting
Columbia, Missouri, United States, 65212
Contact: Dima Dandachi, MD    573-884-8728    dandachid@health.missouri.edu   
Sponsors and Collaborators
University of Missouri-Columbia
Additional Information:
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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: 262095
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
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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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases