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

NCT04707703 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-11-25

No results posted yet for this study

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).

Conditions

  • Severe Acute Respiratory Syndrome Coronavirus 2
  • Aspergillosis Invasive

Interventions

DRUG

Isavuconazonium Injection [Cresemba]

Intravenous isavuconazonium sulfate 372 mg every 8 hours for 6 doses followed by intravenous isavuconazonium sulfate 372 mg once daily for up to 28 days

DRUG

Placebo

Intravenous placebo every 8 hours for 6 doses followed by intravenous placebo once daily for up to 28 days

Sponsors & Collaborators

  • Astellas Pharma Global Development, Inc.

    collaborator INDUSTRY

  • Jeffrey Jenks, MD, MPH

    lead OTHER

Principal Investigators

  • Jeffrey Jenks, MD, MPH · University of California, San Diego

  • George Thompson, MD · University of California, Davis

  • Martin Hoenigl, MD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-16
Primary Completion
2021-10-25
Completion
2021-10-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04707703 on ClinicalTrials.gov