Trial Outcomes & Findings for Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients (NCT NCT05065658)
NCT ID: NCT05065658
Last Updated: 2025-02-17
Results Overview
Compare the incidence of CAPA at time of discharge from the ICU in those who received posaconazole compared to controls who did not
Recruitment status
COMPLETED
Target enrollment
249 participants
Primary outcome timeframe
ICU admission to ICU discharge. On average 20 days
Results posted on
2025-02-17
Participant Flow
Participant milestones
| Measure |
COVID-19 Patients With Acute Respiratory Failure Receiving Posaconazole Prophylaxis (Center 1)
Cases: Intravenous posaconazole prophylaxis
|
COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 2)
Controls: Standard of care (no antifungal prophylaxis)
|
COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 3)
Controls: Standard of care (no antifungal prophylaxis)
|
|---|---|---|---|
|
Overall Study
STARTED
|
83
|
83
|
83
|
|
Overall Study
COMPLETED
|
83
|
83
|
83
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race data were not collected
Baseline characteristics by cohort
| Measure |
COVID-19 Patients With Acute Respiratory Failure Receiving Posaconazole Prophylaxis (Center 1)
n=83 Participants
Cases: Subjects with COVID-19 associated ARF who received intravenous posaconazole prophylaxis upon ICU admission in addition to standard of care treatment
|
COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 2)
n=83 Participants
Controls: Subjects with COVID-19 associated ARF who did not receive antifungal prophylaxis in addition to standard of care treatment
|
COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 3)
n=83 Participants
Controls: Subjects with COVID-19 associated ARF who did not receive antifungal prophylaxis in addition to standard of care treatment
|
Total
n=249 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65 years
n=83 Participants
|
65 years
n=83 Participants
|
66 years
n=83 Participants
|
65 years
n=249 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=83 Participants
|
55 Participants
n=83 Participants
|
54 Participants
n=83 Participants
|
165 Participants
n=249 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=83 Participants
|
28 Participants
n=83 Participants
|
29 Participants
n=83 Participants
|
84 Participants
n=249 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
—
|
—
|
0 Participants
Race data were not collected
|
|
Race (NIH/OMB)
Asian
|
—
|
—
|
—
|
0 Participants
Race data were not collected
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
0 Participants
Race data were not collected
|
|
Race (NIH/OMB)
Black or African American
|
—
|
—
|
—
|
0 Participants
Race data were not collected
|
|
Race (NIH/OMB)
White
|
—
|
—
|
—
|
0 Participants
Race data were not collected
|
|
Race (NIH/OMB)
More than one race
|
—
|
—
|
—
|
0 Participants
Race data were not collected
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
—
|
0 Participants
Race data were not collected
|
|
Region of Enrollment
Austria
|
83 participants
n=83 Participants
|
0 participants
n=83 Participants
|
0 participants
n=83 Participants
|
83 participants
n=249 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=83 Participants
|
83 participants
n=83 Participants
|
0 participants
n=83 Participants
|
83 participants
n=249 Participants
|
|
Region of Enrollment
France
|
0 participants
n=83 Participants
|
0 participants
n=83 Participants
|
83 participants
n=83 Participants
|
83 participants
n=249 Participants
|
|
Tocilizumab Treatment
|
2 Participants
n=83 Participants
|
3 Participants
n=83 Participants
|
1 Participants
n=83 Participants
|
6 Participants
n=249 Participants
|
|
Systemic glucocorticoid treatment
|
83 Participants
n=83 Participants
|
83 Participants
n=83 Participants
|
83 Participants
n=83 Participants
|
249 Participants
n=249 Participants
|
PRIMARY outcome
Timeframe: ICU admission to ICU discharge. On average 20 daysCompare the incidence of CAPA at time of discharge from the ICU in those who received posaconazole compared to controls who did not
Outcome measures
| Measure |
COVID-19 Patients With Acute Respiratory Failure Receiving Posaconazole Prophylaxis (Center 1)
n=83 Participants
Cases: Subjects with COVID-19 associated ARF who received intravenous posaconazole prophylaxis upon ICU admission in addition to standard of care treatment
|
COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 2)
n=83 Participants
Controls: Subjects with COVID-19 associated ARF who did not receive antifungal prophylaxis in addition to standard of care treatment
|
COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 3)
n=83 Participants
Controls: Subjects with COVID-19 associated ARF who did not receive antifungal prophylaxis in addition to standard of care treatment
|
|---|---|---|---|
|
Incidence of COVID-19 Associated Pulmonary Aspergillosis (CAPA)
|
1.69 Cases per 1000 ICU days
|
0.84 Cases per 1000 ICU days
|
7.18 Cases per 1000 ICU days
|
SECONDARY outcome
Timeframe: ICU admission to ICU discharge. On average 20 daysThis 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.
Outcome measures
| Measure |
COVID-19 Patients With Acute Respiratory Failure Receiving Posaconazole Prophylaxis (Center 1)
n=83 Participants
Cases: Subjects with COVID-19 associated ARF who received intravenous posaconazole prophylaxis upon ICU admission in addition to standard of care treatment
|
COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 2)
n=83 Participants
Controls: Subjects with COVID-19 associated ARF who did not receive antifungal prophylaxis in addition to standard of care treatment
|
COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 3)
n=82 Participants
Controls: Subjects with COVID-19 associated ARF who did not receive antifungal prophylaxis in addition to standard of care treatment
|
|---|---|---|---|
|
Risk Factors for CAPA Development (EORTC/MSGERC)
|
8 Participants
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: ICU admission to ICU discharge. On average 20 daysThis 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.
Outcome measures
| Measure |
COVID-19 Patients With Acute Respiratory Failure Receiving Posaconazole Prophylaxis (Center 1)
n=83 Participants
Cases: Subjects with COVID-19 associated ARF who received intravenous posaconazole prophylaxis upon ICU admission in addition to standard of care treatment
|
COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 2)
n=83 Participants
Controls: Subjects with COVID-19 associated ARF who did not receive antifungal prophylaxis in addition to standard of care treatment
|
COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 3)
n=83 Participants
Controls: Subjects with COVID-19 associated ARF who did not receive antifungal prophylaxis in addition to standard of care treatment
|
|---|---|---|---|
|
Risk Factors for CAPA Development (ECMO)
|
13 Participants
|
2 Participants
|
4 Participants
|
Adverse Events
COVID-19 Patients With Acute Respiratory Failure Receiving Posaconazole Prophylaxis (Center 1)
Serious events: 83 serious events
Other events: 0 other events
Deaths: 60 deaths
COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 2)
Serious events: 83 serious events
Other events: 0 other events
Deaths: 14 deaths
COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 3)
Serious events: 83 serious events
Other events: 0 other events
Deaths: 38 deaths
Serious adverse events
| Measure |
COVID-19 Patients With Acute Respiratory Failure Receiving Posaconazole Prophylaxis (Center 1)
n=83 participants at risk
Cases: Subjects with COVID-19 associated ARF who received intravenous posaconazole prophylaxis upon ICU admission in addition to standard of care treatment
|
COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 2)
n=83 participants at risk
Controls: Subjects with COVID-19 associated ARF who did not receive antifungal prophylaxis in addition to standard of care treatment
|
COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 3)
n=83 participants at risk
Controls: Subjects with COVID-19 associated ARF who did not receive antifungal prophylaxis in addition to standard of care treatment
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
100.0%
83/83 • Number of events 83 • From ICU admission to Day 90
|
100.0%
83/83 • Number of events 83 • From ICU admission to Day 90
|
100.0%
83/83 • Number of events 83 • From ICU admission to Day 90
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place