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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT04818853
Collaborator
Centers for Disease Control and Prevention (U.S. Fed), Astellas Pharma Inc (Industry)
400
1
35.7
11.2

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
COVID-19 Associated Pulmonary Aspergillosis (CAPA) and Other Invasive Fungal Infections (IFI)
Actual Study Start Date :
Mar 9, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Participants requiring mechanical ventilation [72 hours or greater]

    Number of patients placed on a ventilator

  2. Participants with all cause mortality [In 30 days]

    Participants with all cause mortality in SARS-CoV-2

  3. Participants with all cause mortality [In 60 days]

    Participants with all cause mortality in SARS-CoV-2

Secondary Outcome Measures

  1. Participants at risk for developing CAPA or IFIs [180 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Alabama at Birmingham Birmingham Alabama United States 35233

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Peter Pappas, MD, The University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peter Pappas, Principle Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT04818853
Other Study ID Numbers:
  • IRB-300006311
First Posted:
Mar 26, 2021
Last Update Posted:
Apr 22, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peter Pappas, Principle Investigator, University of Alabama at Birmingham
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 22, 2022