Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients

Study Overview
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Brief Summary
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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.

Official Title
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Posaconazole for the Prevention of COVID-19 Associated Pulmonary Aspergillosis in Critically-Ill Patients: A European Multicenter Case-Control Study

Conditions
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COVID-19 Respiratory Infection, Aspergillosis

Intervention / Treatment
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* Drug: Posaconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critically-ill COVID-19 patients receiving posaconazole prophylaxis<br> | Drug: Posaconazole<br>* Intravenous posaconazole prophylaxis<br>|
| Critically-ill COVID-19 patients without antifungal prophylaxis<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | ICU admission to ICU discharge. On average 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival at ICU discharge | Compare the rates of survival at time of discharge from the ICU in those who receive posaconazole compared to those who do not | ICU admission to ICU discharge. On average 20 days | 
| Length of ICU stay | Compare the length of ICU stay in those who receive posaconazole compared to those who do not | ICU admission to ICU discharge. On average 20 days | 
| Mortality rate at 30 days | Compare the mortality rate at 30 days in those who receive posaconazole compared to those who do not | ICU admission until 30 days after ICU admission | 
| Mortality rate at 90 days | Compare the mortality rate at 90 days in those who receive posaconazole compared to those who do not | ICU admission until 90 days after ICU admission |