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

NCT ID: NCT04818853

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 219 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-09
• Study Completion Date: 2023-01-13

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).

Conditions

Covid19; Aspergillosis; Fungal Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COVID Patients with Aspergillosis and Other fungal 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.

Observation to monitor patients for these infections

Intervention Type: OTHER

We will be receiving discarded specimens weekly. From these we are going to identify these various potential infections.

Interventions

Observation to monitor patients for these infections

We will be receiving discarded specimens weekly. From these we are going to identify these various potential infections.

Intervention Type: OTHER

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Peter Pappas

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Pappas, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Alabama at Birmingham

Locations

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

2023948

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023158

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-300006311

Identifier Type: -

Identifier Source: org_study_id