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OpenTrials
Completed

NCT Number: NCT04333953

COVID-19 in Patients With HIV

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections COVID-19 Communicable Diseases Coronaviridae Infections Coronavirus Infections Disease Attributes Disease Progression Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Retroviridae Infections SARS-CoV-2 Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention, observational study

Primary outcomes

  1. Mortality

    Time frame: 30 days

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

Prospective Observational Study for Patients With HIV and Confirmed SARS-CoV-2

Important dates

Study start
2020
Primary completion
2020
Study completion
2022
First posted
Apr 3, 2020
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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