Study to assess efficacy and safety of baloxavir marboxil in combination with standard-of-care neuraminidase inhibitor in hospitalized Patients with severe influenza
Phase 3
Completed
- Conditions
- Influenza A and/or B virus infection
- Registration Number
- jRCT2080224144
- Lead Sponsor
- F. Hoffmann-La Roche, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Patients who require hospitalization for severe influenza or acquire influenza during hospitalization, the severity of which requires an extension of hospitalization.
- The time interval between the onset of symptoms and randomization is within 96 hours. etc.
Exclusion Criteria
- Known contraindication to neuraminidase inhibitors.
- Patients with known severe renal impairment or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis. etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Multicenter, randomized, double-blind, parallel-group
- Primary Outcome Measures
Name Time Method Time to Clinical Improvement Up to Day 35 Time to Clinical Improvement is defined as:
- Time to Hospital Discharge OR
- Time to NEWS2 (National Early Warning Score 2) of 2 or lower maintained for 24 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Asia except Japan/North America/South America/Europe/Japan/Oceania
Location not specified
Asia except Japan/North America/South America/Europe/Japan/Oceania