drugset / Trial / NCT04707703
Isavuconazole for the Prevention of COVID-19-associated Pulmonary Aspergillosis
Phase 3
Terminated
8 enrolled
Jeffrey Jenks, MD, MPH
Astellas Pharma Global Development, Inc. · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
The objective of this study is to evaluate whether antifungal prophylaxis with isavuconazole can reduce the incidence of SARS-CoV-2-associated invasive aspergillosis in patients in the ICU (intensive care unit) with severe COVID-19 infection. The investigators will perform an interventional, double-blinded, randomized-controlled, multi-center study in patients with severe COVID-19 infection admitted to the ICU. Patients will be randomized to the isavuconazole prophylaxis plus standard of care (SOC) group or the placebo plus SOC group. Participants will receive isavuconazole or placebo for up to 28 days or until discharge from the hospital (whichever occurs first).
Timeline
- Start
- 2021-03-16
- Primary completion
- 2021-10-25
- Completion
- 2021-10-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Isavuconazonium | Small molecule | 372 mg | Intravenous |