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
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
This study will evaluate the efficacy, safety, and pharmacokinetics of baloxavir marboxil in combination with a standard-of-care (SOC) neuraminidase inhibitor (NAI) (i.e., oseltamivir, zanamivir, or peramivir) compared with a matching placebo in combination with a SOC NAI in hospitalized patients with influenza.
Inclusion Criteria:
Exclusion Criteria:
Decatur, Georgia 30030, United States
Brooklyn, New York 11215, United States
Dimitrovgrad, 6400, Bulgaria
Haskovo, 6305, Bulgaria
Plovdiv, 4002, Bulgaria
Rousse, 7002, Bulgaria
Sliven, 8800, Bulgaria
Smolyan, 4700, Bulgaria
Sofia, 1606, Bulgaria
Sofia, 2233, Bulgaria
Veliko Tarnovo, 5000, Bulgaria
Vratsa, 3000, Bulgaria
Beijing, 100069, China
Shanghai, 200025, China
Freiburg im Breisgau, 79104, Germany
Shatin, New Territories, Hong Kong
Rambam, 3525408, Israel
Dategun Kunimimachi, 969-1793, Japan
Naka-gun, 319-1113, Japan
Shinagawa City, 140-8522, Japan
Yanagawa-shi, 832-0059, Japan
México, Mexico CITY (federal District) 14000, Mexico
Monterrey, 64460, Mexico
Sittard-Geleen, 6162 BG, Netherlands
Nova Sad, 21000, Serbia
Esplugues de Llobregat, Barcelona 08950, Spain
Chernivtsi, Chernihiv Governorate 58005, Ukraine
Kyiv, Katerynoslav Governorate 01601, Ukraine
Sumy, Katerynoslav Governorate 40021, Ukraine
Ternopil, KIEV Governorate 46008, Ukraine
Vinnytsia, KIEV Governorate 21029, Ukraine
Vinnytsia, KIEV Governorate 21032, Ukraine
Dnipro, Podolia Governorate 49006, Ukraine