COVID-19 Associated Pulmonary Aspergillosis (CAPA) and Other Invasive Fungal Infections (IFI)

Completed

• Conditions: Fungal Infection; Covid19; Aspergillosis
• Interventions: Other: Observation to monitor patients for these infections

• Registration Number: NCT04818853
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The purpose of this study is to identify the number of individuals with severe CoVID who require ventilator support and who develop serious fungal infections. The study is an observational study, meaning that we are not providing any intervention that does not involve usual standard of care. Our chief goal is to find evidence of fungal infection by using traditional, approved methods of diagnosis, but by applying these methods in the same way and frequency among all study participants. We will be looking especially for evidence of a fungal infection known as Aspergillus, which can causes a serious lung infection called invasive aspergillosis (IA).

Detailed Description

COVID-19 is a disease caused by infection with the novel coronavirus SARS-COV2 which emerged in late 2019 in Wuhan, China (1). This illness is associated with viral prodromal symptoms, then subsequently fever, cough, and shortness of breath (1). In a subset of patients, lower respiratory tract infection associated with respiratory failure develops. Among these patients, progression to severe respiratory failure and ARDS requiring ventilator support has occurred in an alarming number of patients at rates that are many-fold higher than what is typically associated with seasonal influenza A or B (2). One of the most feared complications of post-influenza respiratory failure is the development of invasive pulmonary aspergillosis which may occur in as many as 15-20% of those requiring ventilator support (based on European data) (3-6). Among those developing IA following influenza A or B, mortality of 50% or greater is reported (3-6).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-03-09
• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-26
• Primary Completion: 2022-07-20
• Study Completion: 2023-01-13
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

Inclusion Criteria

• Adults aged 18 years or older at the time of enrollment
• SARS-COV2 positivity by PCR with respiratory failure requiring mechanical ventilation for at least 72 hours
• Prior therapy with antifungals, including prophylaxis, is NOT an exclusion.

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Exclusion Criteria

• Life expectancy of less than 72 hours as determined by the site investigator.
• Expected to be weaned from mechanical ventilation in next 24 hours
• Care received in any setting other than an intensive care unit (ICU) at the time of enrollment

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID Patients with Aspergillosis and Other fungal Infections	Observation to monitor patients for these infections	All patients have been diagnosed with COVID-19. The purpose of this study is to look at this group of patients in the potential to develop Aspergillosis and other fungal infections.

Primary Outcome Measures

Name	Time	Method
Participants with all cause mortality	In 60 days	Participants with all cause mortality in SARS-CoV-2
Participants requiring mechanical ventilation	72 hours or greater	Number of patients placed on a ventilator

Secondary Outcome Measures

Name	Time	Method
Participants at risk for developing CAPA or IFIs	180 days	Risk factors associated with patients who are at risk for CAPA or IFIs

Trial Locations

Locations (1)

The University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States