A Phase III, Randomized, Double-Blind Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety of Baloxavir Marboxil in Combination With Standard-of-Care Neuraminidase Inhibitor in Hospitalized Participants With Severe Influenza
Latest Information Update: 16 Jun 2022
At a glance
- Drugs Baloxavir-marboxil (Primary) ; Oseltamivir; Peramivir; Zanamivir
- Indications Influenza A virus infections; Influenza B virus infections
- Focus Registrational; Therapeutic Use
- Acronyms FLAGSTONE
- Sponsors Roche
- 01 May 2022 Primary endpoint (Time to Clinical Improvement) has not been met as per results published in The Lancet Infectious Diseases
- 01 May 2022 Results published in The Lancet Infectious Diseases
- 07 Jun 2020 This trial has been completed in France (Global End Date: 16 Mar 2020), according to European Clinical Trials Database record.