Status:
TERMINATED
Isavuconazole for the Prevention of COVID-19-associated Pulmonary Aspergillosis
Lead Sponsor:
Jeffrey Jenks, MD, MPH
Collaborating Sponsors:
Astellas Pharma Global Development, Inc.
Conditions:
Severe Acute Respiratory Syndrome Coronavirus 2
Aspergillosis Invasive
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Adult patients with polymerase chain reaction (PCR)-confirmed SARS-CoV-2 (COVID-19) infection without a diagnosis of invasive aspergillosis who are hospitalized in the ICU are eligible for inclusion i...
Eligibility Criteria
Inclusion
- Written informed consent obtained from the patient or his/her legally authorized person.
- Adult patient (\> 18 years).
- PCR-confirmed SARS-CoV-2 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.
- Radiographic imaging consistent with SARS-CoV-2 infection (e.g. atypical pneumonia, organizing pneumonia, ground glass opacities) or acute respiratory distress syndrome (ARDS) within 7 days of diagnosis of SARS-CoV-2 infection.
- A negative pregnancy test in women of child-bearing age.
- If a woman is of child-bearing age, she must be willing to use an effective method of contraception for 28 days after the final dose of isavuconazole per manufacturer instructions
Exclusion
- Anticipated transfer to another medical center that is not a study site within hours of admission to the ICU.
- Pregnancy based on a positive human chorionic gonadotropin (HCG) test from serum or urine.
- Patient who is breastfeeding and unable to discontinue breastfeeding while taking the study drug.
- Patients with a diagnosis of invasive aspergillosis/detection of Aspergillus spp. by culture from sputum, TA, BA, or BALF or positive GM from serum or BALF at time of screening or randomization.
- History of invasive aspergillosis within the prior six months.
- Patients with a known intolerance or hypersensitivity to isavuconazole or other azole agents.
- History of familial short QT syndrome.
- Patients that are being treated with mold-active antifungal agents for invasive aspergillosis or another invasive fungal infection.
- Patients with severe hepatic impairment or liver cirrhosis (Child C) should be excluded from the study unless the treating physicians feel the benefits of treatment outweigh the risks.
- Treatment with Lopinavir/ritonavir for HIV infection.
- Prohibited Medications
- Co-administration with a strong CYP3A4 inhibitor or high-dose ritonavir as they may alter the plasma concentration of isavuconazole.
- Co-administration with a strong CYP3A4 inducer such as rifampin, carbamazepine, St. John's wort, or long acting barbiturates.
Key Trial Info
Start Date :
March 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04707703
Start Date
March 16 2021
End Date
October 25 2021
Last Update
November 25 2022
Active Locations (3)
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1
University of California Irvine
Orange, California, United States, 92868
2
University of California Davis
Sacramento, California, United States, 95817
3
University of California San Diego
San Diego, California, United States, 92103