COVID-19 Respiratory InfectionPOSACOVIDNCT05065658
Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients
An observational study of COVID-19 Respiratory Infection and Aspergillosis, run by Medical University of Graz at 3 sites in 3 countries.
Trial summary
COVID-19 associated pulmonary aspergillosis (CAPA) is considered a potentially life-threatening infection in critically ill COVID (Corona Virus disease)-19 patients. This study will investigate the efficacy of mold-active prophylaxis with posaconazole for patients with severe SARS (severe acute respiratory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Respiratory Infection, Aspergillosis
- What is being tested?
- Posaconazole
- Type of treatment
- Injection or infusion
- How many people
- 249 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Mar 2020to 23 Aug 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult, Older adult
Study population: The study population will be comprised of patients admitted to the ICU because of severe SARS-CoV-2 infections, who are requiring mechanical ventilation and receive dexamethasone as part of their COVID-19 ARDS treatment in medical centers in i) Graz, Austria (cases), and ii) Genoa, Italy, and iii) Rennes, France (all controls). Posaconazole prophylaxis for ICU patients with severe COVID-19 requiring ICU admission due to ARDS has been introduced in Graz in July 2020, and cases from Graz will be matched with controls from Rennes and Genoa (matching for days on mechanical ventilation at baseline, Apache II score, age, dexamethasone dosage, and underlying disease).
Who may be able to join
- Adult patient (> 18 years)
- PCR (polymerase chain reaction) -confirmed SARS-CoV-2 infections based on nasopharyngeal swab (NPS), oropharyngeal swab (OPS), tracheal aspirate (TA), bronchial aspirate (BA), or bronchoalveolar lavage fluid (BALF) within 14 days prior to ICU admission or within 72 hours following ICU admission due to severe COVID-19 infection
- Radiographic imaging consistent with SARS-CoV-2 infection (e.g. atypical pneumonia, organizing pneumonia, ground glass opacities) or ARDS within 7 days of diagnosis of SARS-CoV-2 infection
Who cannot join
- Patients with a diagnosis of invasive aspergillosis/detection of Aspergillus spp. by culture from sputum, TA, BA, or BALF or positive GM from serum, TA, or BALF at baseline (=ICU admission)
- History of invasive aspergillosis within the prior six months
- Patients that are being treated with mold-active antifungal agents for invasive aspergillosis or another invasive fungal infection
- Patients that are being treated with mold-active antifungal agents for invasive aspergillosis or another invasive fungal infection
- Death or transfer to general ward within 48 hours of ICU admission
- Antifungal prophylaxis other than posaconazole (e.g. inhaled amphotericin B)
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Posaconazole for the Prevention of COVID-19 Associated Pulmonary Aspergillosis in Critically-Ill Patients: A European Multicenter Case-Control Study
COVID-19 associated pulmonary aspergillosis (CAPA) is considered a potentially life-threatening infection in critically ill COVID (Corona Virus disease)-19 patients. This study will investigate the efficacy of mold-active prophylaxis with posaconazole for patients with severe SARS (severe acute respiratory syndrome)-CoV-2 infection admitted to the ICU (intensive care unit) in a multi-center case-control study in Europe.
- Conditions
- COVID-19 Respiratory Infection, Aspergillosis
- Being tested
- Posaconazole
- Medical subject headings
- Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PosaconazoleDrug
Intravenous posaconazole prophylaxis
| Study group | Role | What they receive |
|---|---|---|
| Critically-ill COVID-19 patients receiving posaconazole prophylaxis | Not described Receives: Drug: Posaconazole | |
| Critically-ill COVID-19 patients without antifungal prophylaxis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of COVID-19 Associated Pulmonary Aspergillosis (CAPA)
Compare the incidence of CAPA at time of discharge from the ICU in those who received posaconazole compared to controls who did not
Measured: ICU admission to ICU discharge. On average 20 days
Secondary outcomes (2)
Risk Factors for CAPA Development (EORTC/MSGERC)
This Outcome Measure examines whether the presence of an EORTC/MSGERC-defined risk factor at ICU admission is associated with an increased risk of developing COVID-19-associated pulmonary aspergillosis (CAPA) during the ICU stay. The analysis is conducted using a cohort of patients admitted to the ICU, tracking the development of CAPA from ICU admission to ICU discharge.
For this purpose, the number of subjects who had underlying EORTC/MSGERC risk factors present at ICU admission was collected and used as a parameter in a multivariate logistic model to assess the association with an increased risk for CAPA development.
Measured: ICU admission to ICU discharge. On average 20 days
Risk Factors for CAPA Development (ECMO)
This Outcome Measure examines whether the need for extracorporal membrange oxygenation (ECMO) treatment during ICU admission is associated with an increased risk of developing COVID-19-associated pulmonary aspergillosis (CAPA) during the ICU stay. The analysis is conducted using a cohort of patients admitted to the ICU, tracking the development of CAPA from ICU admission to ICU discharge.
For this purpose, the number of subjects who required ECMO treatment during ICU stay was collected and used as a parameter in a multivariate logistic model to assess the association with an increased risk for CAPA development.
Measured: ICU admission to ICU discharge. On average 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start1 Mar 2020
- Primary completion23 Aug 2023
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065658
- Sponsor's protocol ID
- 32-296 ex 19/20
- Acronym
- POSACOVID
- Status last verified
- Jan 2025
- First submitted
- 9 Sep 2021
- Last updated
- 17 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Prattes J, Giacobbe DR, Marelli C, Signori A, Dettori S, Cattardico G, Hatzl S, Reisinger AC, Eller P, Krause R, Reizine F, Bassetti M, Gangneux JP, Hoenigl M. Posaconazole for Prevention of COVID-19-Associated Pulmonary Aspergillosis in Mechanically Ventilated Patients: A European Multicentre Case-Control Study (POSACOVID). Mycoses. 2025 Jan;68(1):e70023. doi: 10.1111/myc.70023.
PubMed 39800852
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posaconazole for the Prevention of COVID-19 Associated Pulmonary Aspergillosis in Critically-Ill Patients: A European Multicenter Case-Control Study
- ClinicalTrials.gov ID
- NCT05065658
- Acronym / sponsor ID
- POSACOVID / 32-296 ex 19/20
- Conditions
- COVID-19 Respiratory Infection, Aspergillosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 4 Oct 2021 (actual)
- Results
- Posted 17 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
COVID-19 associated pulmonary aspergillosis (CAPA) is considered a potentially life-threatening infection in critically ill COVID (Corona Virus disease)-19 patients. This study will investigate the efficacy of mold-active prophylaxis with posaconazole for patients with severe SARS (severe acute respiratory syndrome)-CoV-2 infection admitted to the ICU (intensive care unit) in a multi-center case-control study in Europe.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Critically-ill COVID-19 patients receiving posaconazole prophylaxis | – | Drug: Posaconazole |
| Critically-ill COVID-19 patients without antifungal prophylaxis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will be comprised of patients admitted to the ICU because of severe SARS-CoV-2 infections, who are requiring mechanical ventilation and receive dexamethasone as part of their COVID-19 ARDS treatment in medical centers in i) Graz, Austria (cases), and ii) Genoa, Italy, and iii) Rennes, France (all controls). Posaconazole prophylaxis for ICU patients with severe COVID-19 requiring ICU admission due to ARDS has been introduced in Graz in July 2020, and cases from Graz will be matched with controls from Rennes and Genoa (matching for days on mechanical ventilation at baseline, Apache II score, age, dexamethasone dosage, and underlying disease).
Key inclusion criteria (3 listed)
- Adult patient (> 18 years)
- PCR (polymerase chain reaction) -confirmed SARS-CoV-2 infections based on nasopharyngeal swab (NPS), oropharyngeal swab (OPS), tracheal aspirate (TA), bronchial aspirate (BA), or bronchoalveolar lavage fluid (BALF) within 14 days prior to ICU admission or within 72 hours following ICU admission due to severe COVID-19 infection
- Radiographic imaging consistent with SARS-CoV-2 infection (e.g. atypical pneumonia, organizing pneumonia, ground glass opacities) or ARDS within 7 days of diagnosis of SARS-CoV-2 infection
Key exclusion criteria (6 listed)
- Patients with a diagnosis of invasive aspergillosis/detection of Aspergillus spp. by culture from sputum, TA, BA, or BALF or positive GM from serum, TA, or BALF at baseline (=ICU admission)
- History of invasive aspergillosis within the prior six months
- Patients that are being treated with mold-active antifungal agents for invasive aspergillosis or another invasive fungal infection
- Patients that are being treated with mold-active antifungal agents for invasive aspergillosis or another invasive fungal infection
- Death or transfer to general ward within 48 hours of ICU admission
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 |
|---|---|---|
| PosaconazoleIntravenous posaconazole prophylaxis | Drug | Critically-ill COVID-19 patients receiving posaconazole prophylaxis |
Primary outcome
Incidence of COVID-19 Associated Pulmonary Aspergillosis (CAPA)
Time frame: ICU admission to ICU discharge. On average 20 days
Compare the incidence of CAPA at time of discharge from the ICU in those who received posaconazole compared to controls who did not
2 secondary outcomes
Risk Factors for CAPA Development (EORTC/MSGERC)
Time frame: ICU admission to ICU discharge. On average 20 days
Risk Factors for CAPA Development (ECMO)
Time frame: ICU admission to ICU discharge. On average 20 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39800852Prattes J, Giacobbe DR, Marelli C, Signori A, Dettori S, Cattardico G, Hatzl S, Reisinger AC, Eller P, Krause R, Reizine F, Bassetti M, Gangneux JP, Hoenigl M. Posaconazole for Prevention of COVID-19-Associated Pulmonary Aspergillosis in Mechanically Ventilated Patients: A European Multicentre Case-Control Study (POSACOVID). Mycoses. 2025 Jan;68(1):e70023. doi: 10.1111/myc.70023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Respiratory Infection and Aspergillosis, run by Medical University of Graz at 3 sites in 3 countries.
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 6 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 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, France, Italy. 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?
Yes. Results are posted in the registry (first posted 17 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of COVID-19 Associated Pulmonary Aspergillosis (CAPA) (time frame: ICU admission to ICU discharge. On average 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05065658, which also lists 1 linked publication.
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 17 Feb 2025.