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

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).

Study Overview

• Status: Recruiting
• Conditions: Covid19; Fungal Infection; Aspergillosis
• Intervention / Treatment: Other: Observation to monitor patients for these infections

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).

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Rachel McMullen, BS; Phone Number: 2059347292; Email: rlmcmullen@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • The University of Alabama at Birmingham
      • Principal Investigator: Peter Pappas, MD
      • Contact: Rachel McMullen, BS; Phone Number: 205-934-7292; Email: rlmcmullen@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; We will be receiving discarded specimens weekly. From these we are going to identify these various potential infections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants at risk for developing CAPA or IFIs	Risk factors associated with patients who are at risk for CAPA or IFIs	180 days

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Astellas Pharma Inc; Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Peter Pappas, MD, The University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2021
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: COVID19; Aspergillosis; CAPA; Fungal
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Bacterial Infections and Mycoses; Lung Diseases, Fungal; COVID-19; Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections; Aspergillosis; Pulmonary Aspergillosis
• Other Study ID Numbers: IRB-300006311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To Be Determined

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No