TerminatedPhase 3

Isavuconazole for the Prevention of COVID-19-associated Pulmonary Aspergillosis

Stopped: Participant enrollment challenges

United States8 participantsStarted 2021-03-16

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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…

What they're measuring

The incidence of SARS-CoV-2-associated invasive aspergillosis at time of ICU discharge

Timeframe: From date of admission in ICU assessed up to ICU discharge, approximately 28 days

Trial details

NCT IDNCT04707703

SponsorJeffrey Jenks, MD, MPH

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-25