Clinical trial NCT04818853: COVID-19 Associated Pulmonary Aspergillosis (CAPA) and Other Invasive Fungal Infections (IFI)
Official title: COVID-19 Associated Pulmonary Aspergillosis (CAPA) and Other Invasive Fungal Infections (IFI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Aspergillosis
Fungal Infection
Keywords: COVID19
Aspergillosis
Fungal
CAPA
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Astellas Pharma Inc
First posted: 2021-03-26
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

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

Primary outcomes:
measure: Participants requiring mechanical ventilation
timeFrame: 72 hours or greater
measure: Participants with all cause mortality
timeFrame: In 30 days
measure: Participants with all cause mortality
timeFrame: In 60 days
Secondary outcomes:
measure: Participants at risk for developing CAPA or IFIs
timeFrame: 180 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: The University of Alabama at Birmingham
name: Peter Pappas, MD
role: PRINCIPAL_INVESTIGATOR
References: