Covid19CAPA IFINCT04818853
COVID-19 Associated Pulmonary Aspergillosis (CAPA) and Other Invasive Fungal Infections (IFI)
An observational study of Covid19 and Aspergillosis, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Aspergillosis, Fungal Infection
- What is being tested?
- Observation to monitor patients for these infections
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2021to 13 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
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).
Read the 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).
- Conditions
- Covid19, Aspergillosis, Fungal Infection
- Being tested
- Observation to monitor patients for these infections
- Keywords
- COVID19, Aspergillosis, Fungal, CAPA
- Medical subject headings
- COVID-19, Aspergillosis, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation to monitor patients for these infectionsOther
We will be receiving discarded specimens weekly. From these we are going to identify these various potential infections.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observation to monitor patients for these infections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants requiring mechanical ventilation
Number of patients placed on a ventilator
Measured: 72 hours or greater
Participants with all cause mortality
Participants with all cause mortality in SARS-CoV-2
Measured: In 30 days
Participants with all cause mortality
Participants with all cause mortality in SARS-CoV-2
Measured: In 60 days
Secondary outcomes (1)
Participants at risk for developing CAPA or IFIs
Risk factors associated with patients who are at risk for CAPA or IFIs
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start9 Mar 2021
- Primary completion20 Jul 2022
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Astellas Pharma Inc
- Responsible party
- Principal investigator, Peter Pappas, University of Alabama at Birmingham
- Investigators
- Peter Pappas, MD, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818853
- Sponsor's protocol ID
- IRB-300006311
- Other IDs
- 2023948, 2023158
- Acronym
- CAPA IFI
- Status last verified
- Jan 2026
- First submitted
- 25 Mar 2021
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To Be Determined
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Associated Pulmonary Aspergillosis (CAPA) and Other Invasive Fungal Infections (IFI)
- ClinicalTrials.gov ID
- NCT04818853
- Acronym / sponsor ID
- CAPA IFI / IRB-300006311
- Conditions
- Covid19, Aspergillosis, Fungal Infection
- Keywords
- COVID19, Aspergillosis, Fungal, CAPA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Astellas Pharma Inc
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID Patients with Aspergillosis and Other fungal Infections | – | Other: Observation to monitor patients for these infectionsAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation to monitor patients for these infectionsWe will be receiving discarded specimens weekly. From these we are going to identify these various potential infections. | Other | COVID Patients with Aspergillosis and Other fungal Infections |
Primary outcome
Participants requiring mechanical ventilation
Time frame: 72 hours or greater
Number of patients placed on a ventilator
Participants with all cause mortality
Time frame: In 30 days
Participants with all cause mortality in SARS-CoV-2
Participants with all cause mortality
Time frame: In 60 days
Participants with all cause mortality in SARS-CoV-2
1 secondary outcome
Participants at risk for developing CAPA or IFIs
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No. To Be Determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Pappas, MD principal investigator
The University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Aspergillosis, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants requiring mechanical ventilation (time frame: 72 hours or greater). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.