363
Participants
Start Date
January 8, 2019
Primary Completion Date
March 16, 2020
Study Completion Date
March 16, 2020
Baloxavir Marboxil
Baloxavir marboxil will be administered as a weight-based dose on Days 1 and 4. A third dose will be given on Day 7 for participants who have not improved according to protocol defined criteria on Day 5.
Placebo
Participants will receive matching placebo on Days 1, 4 and 7.
Hopital Erasme; Chest Medicine, Cardiac & Thoracic Surgery, Brussels
First Multiprofile Hospital for Active Treatment - Sofia EAD, Sofia
Cliniques Universitaires Saint-Luc; Hematology, Brussels
Fifth Multiprofile Hospital for Active Treatment - Sofia EAD; Pharmacy, Sofia
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia; Pharmacy, Sofia
Instituto Medico Platense, La Plata
Multiprofile Hospital for Active Treatment - Samokov EOOD, Samokov
National Multiprofile Transport Hospital Tzar Boris Ill; Clinic of Internal Diseases, Sofia
UZ Leuven, Leuven
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa; Pharmacy, Vratsa
Royal Children's Hospital Melbourne - PIN, Parkville
MHAT Stamen Iliev AD; Pharmacy, Montana
University Mulitiprofile Hospital for Active Treatment Sveti Georgi EAD; Pharmacy, Plovdiv
Royal Brisbane & Womens Hospital; Pharmacy Department, Herston
Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD; Pharmacy, Smolyan
Multiprofile District Hospital for Active Treatment Dr. Stefan Cherkezov AD; Pharmacy, Veliko Tarnovo
Wellington Hospital, Wellington
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD, Haskovo
Multiprofile Hospital For Active Treatment Sveta Ekaterina Dimitrovgrad EOOD; Internal Diseases, Dimitrovgrad
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr. D. Gramatikov - Ruse, Rousse
Multiprofile Hospital For Active Treatment Sliven То Military Hospital Sofia; Pharmacy, Sliven
China-Japan Friendship Hospital, Beijing
East Tallinn Central Hospital, Tallinn
Clinical Center of Serbia, Belgrade
Clinical Hospital Center Zvezdara, Belgrade
New York-Presbyterian Brooklyn Methodist Hospital; Department of Emergency Medicine, Brooklyn
ZIV Medical Center; Department Of Internal Medicine A, Safed
Seoul National University Bundang Hospital, Seongnam-si
Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran; Hamatologia y Oncologia, México
Baruch Padeh Poria Medical Center; Pharmacy, Tiberias
Clinical Center Nis; Clinic for Pulmonary Diseases and Tuberculosis Knez Selo, Niš
Temple University Hospital ; Lung Center, Philadelphia
Turku University Hospital, Turku
Clinical Centre of Vojvodina, Nova Sad
"Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital №1; Infectious Department", Vinnytsia
MI Vinnytsia Regional Clinical Children's Infectious Hospital; Infectiuos Box department, Vinnytsia
CHRU Dijon Complexe Du Bocage, Dijon
Prof. Dr. Matei Bals Institute of Infectious Diseases, Bucharest
Institute of Lung Diseases Vojvodina, Kamenitz
The Catholic University of Korea Incheon St. Mary's Hospital, Incheon
Galilee Medical Center, Nahariya
Hospital General de Tijuana, Tijuana
Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I, Lübeck
Salem Veterans Affairs Medical Center - NAVREF; Pharmacy, Salem
General Hospital Dr Radivoj Simonovic Sombor, Sombor
Hospital Universitario Fundacion Jimenez Diaz., Madrid
Hospital Universitario de Torrejon, Torrejón de Ardoz
Hospital General Universitario Reina Sofia; Servicio de Nefrologia, Murcia
CHU de Nîmes - Hôpital Carémeau, Nîmes
Atlanta Institute For Medical Research, Inc; DeKalb Medical Pharmacy, Decatur
Dr. Victor Babes Clinical Hospital For Tropical and Infectious Diseases, Bucharest
Medizinische Hochschule Hannover, Hanover
Clinical Center Kragujevac, Kragujevac
CHRU Bretonneau, Tours
Hospital Universitario Marques de Valdecilla, Santander
Regional Municipal Institution Sumy Regional Infectious Clinical Hospital n.a. Z.Y. Krasovytskyi, Sumy
Hospital Universitario Virgen Macarena, Seville
Selcuk University Medical Faculty; Internal Medicine, Konya
CHRU Nantes, Nantes
Hospital Civil Fray Antonio Alcalde; Instituto de Patologia Infecciosa, Guadalajara
Hopital de La Source, Orléans
Ternopil City Municipal Emergency Hospital; Infectious Department, Ternopil
Hospital de La Ribera, Valencia
Detroit Receiving Hospital, Detroit
MI Dnipropetrovsk City Clinical Hospital #21 n.a. Prof. Popkova of DRC; The First Department, Dnipro
Uniklinik Koln; Klinik I fur Innere Medizin, Cologne
Froedtert and The Medical College of Wisconsin, Milwaukee
Regional Municipal Institution Chernivtsi Regional Clinical Hospital, Chernivtsi
Edith Wolfson Medical Center, Holon
Mercury Street Medical Group, Butte
NorthShore University HealthSystem, Evanston
University of Chicago; Oncology Dept, Chicago
Karadeniz Technical University Faculty of Medicine, Trabzon
Washington University School of Medicine, St Louis
Hospital Universitario Dr. Jose Eleuterio González; Enfermedades Pulmonares Crónicas, Monterrey
Municipal Institution City Clinical Infectious Diseases Hospital, Odesa
Nouvel Hopital Civil - CHU Strasbourg, Strasbourg
Creighton University Medical Center, Omaha
Klinikum Mannheim GmbH Universitätsklinikum, Mannheim
Kuopion Yliopistollinen Sairaala; Silmätaudit, Kuopio
Barnum Medical Research, Inc., Natchitoches
Universitatsklinikum Tubingen, Tübingen
Groupe Hospitalier Pitie Salpetriere; Service De Pneumologie, Paris
St. Josefskrankenhaus - Freiburg; Klinik fur Pneumologieund Beatmungsmedizin, Freiburg im Breisgau
Denver Health Medical Center, Denver
Centre Hospitalier Departemental de Vendee, La Roche-sur-Yon
Hôpital Universitaire Dupuytren, Limoges
Oulun Yliopistollinen Sairaala; Teho-osasto, Oulu
Torrance Memorial Medical Center, Torrance
Klinikum der Universität Regensburg, Regensburg
Krankenhaus Donaustauf der LVA Niederbayern Oberpfalz, Donaustauf
Centre Hospitalier Victor Dupouy, Argenteuil
Beijing Ditan Hospital Capital Medical University, Beijing
Beijing Youan Hospital, Capital Medical University; Center for Infectious Diseases, Beijing
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital), Shanghai
Zhongshan Hospital Fudan University, Shanghai
Shanghai Public Health Clinical Center, Shanghai
Tan Tock Seng Hospital, Singapore
The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou
The 1st Affiliated Hospital of Nanchang Unversity, Nanchang
Spitalul Clinic de Boli Infectioase, Cluj-Napoca
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou
Sibiu Emergency Clinical County Hospital, Sibiu
West China Hospital, Sichuan University, Chengdu
"Spitalul Clinic de Boli Infectioase Sfanta Parascheva Iasi", Iași
Sf. Ioan cel Nou Emergency County Hospital, Suceava
Sf.Cuv. Parascheva Infectious Diseases Clinical Hospital, Galati
Rambam Health Corporation; Oncology Institute, Rambam
Chaim Sheba Medical Center; Allergy and Clinical Immunology Unit, Ramat Gan
Tel Aviv Sourasky Medical Center; Pharmacy, Tel Aviv
Soroka University Medical Centre, Beersheba
Santa Casa de Misericordia; de Belo Horizonte, Belo Horizonte
Hospital Sao Vicente de Paulo, Passo Fundo
Centro de Estudos Clinicos do Interior Paulista, Jaú
Peter Lougheed Centre, Calgary
Foothills Medical Centre, Calgary
Carlson Urology, Calgary
South Health Campus, Calgary
University of Alberta Hospital, Edmonton
Toronto East General Hospital; Main Pharmacy G Wing Basement, East York
London Health Sciences Center; Pharmacy Dept., London
Institut Universitaire de Cardiologie et de Pneumologie, Québec
Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika, Brno
Nemocnice Kyjov, prispevkova organizace, Kyjov
Universitätsklinikum Carl Gustav Carus an der TU Dresden, Dresden
Princess Margaret Hospital, Hong Kong
Queen Mary Hospital, Hong Kong
Prince of Wales Hospital, Shatin, New Territories
Fujita General Hospital, Dategun Kunimimachi
Shin Komonji Hospital, Fukuoka
Fukuoka Shin Mizumaki Hospital, Fukuoka
Fukuoka Wajiro Hospital, Fukuoka
Rinku General Medical Center, Izumisano
National Hospital Organization Minami Kyoto Hospital, Jōyō
National Hospital Organization Kanazawa Medical Center, Kanazawa
Japanese Red Cross Kumamoto Hospital, Kumamoto
Naha City Hospital, Naha
National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research, Naka-gun
Japan Community Health care Organization Nihonmatsu hospital, Nihonmatsu
Social Corporation Keigakukai Minamiosaka Hosupital, Osaka
National Hospital Organaization Shibukawa Medical Center, Shibukawa
Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai, Shinagawa City
Saka General Hospital, Shiogama
Local incorporated administrative agency Shizuoka City Shizuoka Hospital, Shizuoka
Iwase General Hospital, Sukagawa
Center Hospital of the National Center for Global Health and Medicine, Tokyo
Nagata Hospital; Department of pulmonary medicine, Yanagawa-shi
Leids Universitair Medisch Centrum; C5-P Stafcentrum Hartziekten, Leiden
Canisius Wilhelmina Ziekenhuis; Department Hematology, Nijmegen
Ikazia Ziekenhuis, Rotterdam
Zuyderland Medisch Centrum - Sittard Geleen, Sittard-Geleen
Universitair Medisch Centrum Utrecht, Utrecht
Hospital Alberto Sabogal Sologuren, Callao
Hospital Nacional Adolfo Guevara Velasco - ESSALUD; Servicio de Cardiología, Cusco
Korea University Anam Hospital, Seoul
Seoul National University Hospital, Seoul
Asan Medical Center, Seoul
ChungAng University Hospital, Seoul
Hallym University Kangnam Sacred Heart Hospital, Seoul
Hospital Universitario Germans Trias i Pujol, Badalona
Hospital Sant Joan de Deu - PIN; Unitat de Recerca - Farmacia, Esplugues de Llobregat
Hospital Mutua de Terrassa, Terrassa
Hospital General Universitario de Alicante, Alicante
Hospital del Mar, Barcelona
Hospital Universitario Vall d'Hebron - PPDS, Barcelona
Sahlgrenska Universitetssjukhuset, Gothenburg
Skånes Universitetssjukhus Malmö; Infektionskliniken, Malmo
Hacettepe University Medical Faculty, Ankara
Akdeniz University Medical Faculty, Antalya
Kyiv Oleksandrivska Clinical Hospital; Infectious Box Department #2, Kyiv
Hoffmann-La Roche
INDUSTRY