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

Covid19 Clinical Trial

— CAPA IFI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04818853
• Other study ID #: IRB-300006311
• Status: Recruiting
• Start date: March 9, 2021
• Est. completion date: March 1, 2024

Study information

• Verified date: October 2023
• Source: University of Alabama at Birmingham
• Contact: Rachel McMullen, BS
• Phone: 2059347292
• Email: rlmcmullen[@]uabmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aspergillosis
• Communicable Diseases
• COVID-19
• Covid19
• Fungal Infection
• Infections
• Invasive Fungal Infections
• Mycoses
• Pulmonary Aspergillosis

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Astellas Pharma Inc, Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants requiring mechanical ventilation	Number of patients placed on a ventilator	72 hours or greater
Primary	Participants with all cause mortality	Participants with all cause mortality in SARS-CoV-2	In 30 days
Primary	Participants with all cause mortality	Participants with all cause mortality in SARS-CoV-2	In 60 days
Secondary	Participants at risk for developing CAPA or IFIs	Risk factors associated with patients who are at risk for CAPA or IFIs	180 days