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OpenTrials
Completed

NCT Number: NCT04818853

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Participants requiring mechanical ventilation

    Time frame: 72 hours or greater

    Number of patients placed on a ventilator

  2. Participants with all cause mortality

    Time frame: In 30 days

    Participants with all cause mortality in SARS-CoV-2

  3. Participants with all cause mortality

    Time frame: In 60 days

    Participants with all cause mortality in SARS-CoV-2

Secondary outcomes

  1. Participants at risk for developing CAPA or IFIs

    Time frame: 180 days

    Risk factors associated with patients who are at risk for CAPA or IFIs

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Astellas Pharma Inc
  • Centers for Disease Control and Prevention

Registry information

Acronym: CAPA IFI

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 26, 2021
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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