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

NCT04818853 | Completed

• 3 other identifiers: IRB-30000631120239482023158
• Study Type: observational
• Target: 219
• Locations: 1 country
• Sites: 1

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).

Conditions

Covid19; Aspergillosis; Fungal Infection

Keywords

COVID19; Aspergillosis; Fungal; CAPA

Outcome Measures

Primary Outcomes (3)

• Participants requiring mechanical ventilation

  Number of patients placed on a ventilator

  72 hours or greater

• Participants with all cause mortality

  Participants with all cause mortality in SARS-CoV-2

  In 30 days

• Participants with all cause mortality

  Participants with all cause mortality in SARS-CoV-2

  In 60 days

Secondary Outcomes (1)

• Participants at risk for developing CAPA or IFIs

  180 days

Study Arms (1)

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.

Other: Observation to monitor patients for these infections

Interventions

Observation to monitor patients for these infections OTHER

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

COVID Patients with Aspergillosis and Other fungal Infections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult Intensive Care Unit Patients with SARS-CoV2 requiring greater than 72 hours of mechanical ventilation. Participating sites include: University of Alabama at Birmingham, University of Pittsburgh, Washington University in St. Louis, University of California at Davis, University of Texas at Houston, University of Maryland, and University of Texas Health Sciences Center at San Antonio, Cornell University and Columbia/Presbyterian Medical Center

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Centers for Disease Control and Prevention: collaborator
• Astellas Pharma Inc: collaborator

Study Sites (1)

The University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Discarded clinical samples from routine testing will be collected and tested for diagnostic purposes on a weekly basis. These will include serum, deep suction specimens, and BAL when available. These samples will be tested for Aspergillus GM, Aspergillus PCR, and Pneumocystis PCR. Specimens will be stored at the CDC biorepository for future diagnostic use.

MeSH Terms

Conditions

COVID-19; Aspergillosis; Mycoses

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Bacterial Infections and Mycoses

Study Officials

• Peter Pappas, MD

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 26, 2021
• Study Start: March 9, 2021
• Primary Completion: July 20, 2022
• Study Completion: January 13, 2023
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)