Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza

PHASE3CompletedINTERVENTIONAL
Enrollment

363

Participants

Timeline

Start Date

January 8, 2019

Primary Completion Date

March 16, 2020

Study Completion Date

March 16, 2020

Conditions
Influenza
Interventions
DRUG

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.

OTHER

Placebo

Participants will receive matching placebo on Days 1, 4 and 7.

Trial Locations (170)

1070

Hopital Erasme; Chest Medicine, Cardiac & Thoracic Surgery, Brussels

1142

First Multiprofile Hospital for Active Treatment - Sofia EAD, Sofia

1200

Cliniques Universitaires Saint-Luc; Hematology, Brussels

1233

Fifth Multiprofile Hospital for Active Treatment - Sofia EAD; Pharmacy, Sofia

1606

Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia; Pharmacy, Sofia

1900

Instituto Medico Platense, La Plata

2000

Multiprofile Hospital for Active Treatment - Samokov EOOD, Samokov

2233

National Multiprofile Transport Hospital Tzar Boris Ill; Clinic of Internal Diseases, Sofia

3000

UZ Leuven, Leuven

Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa; Pharmacy, Vratsa

3052

Royal Children's Hospital Melbourne - PIN, Parkville

3400

MHAT Stamen Iliev AD; Pharmacy, Montana

4002

University Mulitiprofile Hospital for Active Treatment Sveti Georgi EAD; Pharmacy, Plovdiv

4029

Royal Brisbane & Womens Hospital; Pharmacy Department, Herston

4700

Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD; Pharmacy, Smolyan

5000

Multiprofile District Hospital for Active Treatment Dr. Stefan Cherkezov AD; Pharmacy, Veliko Tarnovo

6012

Wellington Hospital, Wellington

6305

Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD, Haskovo

6400

Multiprofile Hospital For Active Treatment Sveta Ekaterina Dimitrovgrad EOOD; Internal Diseases, Dimitrovgrad

7002

Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr. D. Gramatikov - Ruse, Rousse

8800

Multiprofile Hospital For Active Treatment Sliven То Military Hospital Sofia; Pharmacy, Sliven

10029

China-Japan Friendship Hospital, Beijing

10138

East Tallinn Central Hospital, Tallinn

11000

Clinical Center of Serbia, Belgrade

Clinical Hospital Center Zvezdara, Belgrade

11215

New York-Presbyterian Brooklyn Methodist Hospital; Department of Emergency Medicine, Brooklyn

13100

ZIV Medical Center; Department Of Internal Medicine A, Safed

13605

Seoul National University Bundang Hospital, Seongnam-si

14000

Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran; Hamatologia y Oncologia, México

15208

Baruch Padeh Poria Medical Center; Pharmacy, Tiberias

18204

Clinical Center Nis; Clinic for Pulmonary Diseases and Tuberculosis Knez Selo, Niš

19140

Temple University Hospital ; Lung Center, Philadelphia

20521

Turku University Hospital, Turku

21000

Clinical Centre of Vojvodina, Nova Sad

21029

"Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital №1; Infectious Department", Vinnytsia

21032

MI Vinnytsia Regional Clinical Children's Infectious Hospital; Infectiuos Box department, Vinnytsia

21079

CHRU Dijon Complexe Du Bocage, Dijon

21105

Prof. Dr. Matei Bals Institute of Infectious Diseases, Bucharest

21204

Institute of Lung Diseases Vojvodina, Kamenitz

21431

The Catholic University of Korea Incheon St. Mary's Hospital, Incheon

22100

Galilee Medical Center, Nahariya

22320

Hospital General de Tijuana, Tijuana

23538

Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I, Lübeck

24153

Salem Veterans Affairs Medical Center - NAVREF; Pharmacy, Salem

25000

General Hospital Dr Radivoj Simonovic Sombor, Sombor

28040

Hospital Universitario Fundacion Jimenez Diaz., Madrid

28850

Hospital Universitario de Torrejon, Torrejón de Ardoz

30003

Hospital General Universitario Reina Sofia; Servicio de Nefrologia, Murcia

30029

CHU de Nîmes - Hôpital Carémeau, Nîmes

30030

Atlanta Institute For Medical Research, Inc; DeKalb Medical Pharmacy, Decatur

30303

Dr. Victor Babes Clinical Hospital For Tropical and Infectious Diseases, Bucharest

30625

Medizinische Hochschule Hannover, Hanover

34000

Clinical Center Kragujevac, Kragujevac

37044

CHRU Bretonneau, Tours

39008

Hospital Universitario Marques de Valdecilla, Santander

40021

Regional Municipal Institution Sumy Regional Infectious Clinical Hospital n.a. Z.Y. Krasovytskyi, Sumy

41009

Hospital Universitario Virgen Macarena, Seville

42050

Selcuk University Medical Faculty; Internal Medicine, Konya

44093

CHRU Nantes, Nantes

44280

Hospital Civil Fray Antonio Alcalde; Instituto de Patologia Infecciosa, Guadalajara

45067

Hopital de La Source, Orléans

46008

Ternopil City Municipal Emergency Hospital; Infectious Department, Ternopil

46600

Hospital de La Ribera, Valencia

48201

Detroit Receiving Hospital, Detroit

49006

MI Dnipropetrovsk City Clinical Hospital #21 n.a. Prof. Popkova of DRC; The First Department, Dnipro

50937

Uniklinik Koln; Klinik I fur Innere Medizin, Cologne

53226

Froedtert and The Medical College of Wisconsin, Milwaukee

58005

Regional Municipal Institution Chernivtsi Regional Clinical Hospital, Chernivtsi

58100

Edith Wolfson Medical Center, Holon

59701

Mercury Street Medical Group, Butte

60201

NorthShore University HealthSystem, Evanston

60637

University of Chicago; Oncology Dept, Chicago

61080

Karadeniz Technical University Faculty of Medicine, Trabzon

63110

Washington University School of Medicine, St Louis

64460

Hospital Universitario Dr. Jose Eleuterio González; Enfermedades Pulmonares Crónicas, Monterrey

65023

Municipal Institution City Clinical Infectious Diseases Hospital, Odesa

67091

Nouvel Hopital Civil - CHU Strasbourg, Strasbourg

68131

Creighton University Medical Center, Omaha

68167

Klinikum Mannheim GmbH Universitätsklinikum, Mannheim

70210

Kuopion Yliopistollinen Sairaala; Silmätaudit, Kuopio

71457

Barnum Medical Research, Inc., Natchitoches

72076

Universitatsklinikum Tubingen, Tübingen

75651

Groupe Hospitalier Pitie Salpetriere; Service De Pneumologie, Paris

79104

St. Josefskrankenhaus - Freiburg; Klinik fur Pneumologieund Beatmungsmedizin, Freiburg im Breisgau

80204

Denver Health Medical Center, Denver

85925

Centre Hospitalier Departemental de Vendee, La Roche-sur-Yon

87042

Hôpital Universitaire Dupuytren, Limoges

90220

Oulun Yliopistollinen Sairaala; Teho-osasto, Oulu

90505

Torrance Memorial Medical Center, Torrance

93053

Klinikum der Universität Regensburg, Regensburg

93093

Krankenhaus Donaustauf der LVA Niederbayern Oberpfalz, Donaustauf

95107

Centre Hospitalier Victor Dupouy, Argenteuil

100015

Beijing Ditan Hospital Capital Medical University, Beijing

100069

Beijing Youan Hospital, Capital Medical University; Center for Infectious Diseases, Beijing

200025

Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital), Shanghai

200032

Zhongshan Hospital Fudan University, Shanghai

201508

Shanghai Public Health Clinical Center, Shanghai

308433

Tan Tock Seng Hospital, Singapore

310003

The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou

330006

The 1st Affiliated Hospital of Nanchang Unversity, Nanchang

400000

Spitalul Clinic de Boli Infectioase, Cluj-Napoca

510120

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou

550245

Sibiu Emergency Clinical County Hospital, Sibiu

610041

West China Hospital, Sichuan University, Chengdu

700116

"Spitalul Clinic de Boli Infectioase Sfanta Parascheva Iasi", Iași

720224

Sf. Ioan cel Nou Emergency County Hospital, Suceava

800179

Sf.Cuv. Parascheva Infectious Diseases Clinical Hospital, Galati

3525408

Rambam Health Corporation; Oncology Institute, Rambam

5266202

Chaim Sheba Medical Center; Allergy and Clinical Immunology Unit, Ramat Gan

6423906

Tel Aviv Sourasky Medical Center; Pharmacy, Tel Aviv

8410101

Soroka University Medical Centre, Beersheba

30150-221

Santa Casa de Misericordia; de Belo Horizonte, Belo Horizonte

99010-090

Hospital Sao Vicente de Paulo, Passo Fundo

17201-130

Centro de Estudos Clinicos do Interior Paulista, Jaú

T1Y 6J4

Peter Lougheed Centre, Calgary

T2N-2T9

Foothills Medical Centre, Calgary

T2V 1P9

Carlson Urology, Calgary

T3M 1M4

South Health Campus, Calgary

T6G 1Z1

University of Alberta Hospital, Edmonton

M4C 3E7

Toronto East General Hospital; Main Pharmacy G Wing Basement, East York

N6A 5W9

London Health Sciences Center; Pharmacy Dept., London

G1V 4G5

Institut Universitaire de Cardiologie et de Pneumologie, Québec

625 00

Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika, Brno

697 33

Nemocnice Kyjov, prispevkova organizace, Kyjov

01307

Universitätsklinikum Carl Gustav Carus an der TU Dresden, Dresden

Unknown

Princess Margaret Hospital, Hong Kong

Queen Mary Hospital, Hong Kong

Prince of Wales Hospital, Shatin, New Territories

969-1793

Fujita General Hospital, Dategun Kunimimachi

800-0057

Shin Komonji Hospital, Fukuoka

807-0051

Fukuoka Shin Mizumaki Hospital, Fukuoka

811-0213

Fukuoka Wajiro Hospital, Fukuoka

598-0048

Rinku General Medical Center, Izumisano

610-0113

National Hospital Organization Minami Kyoto Hospital, Jōyō

920-8650

National Hospital Organization Kanazawa Medical Center, Kanazawa

861-8520

Japanese Red Cross Kumamoto Hospital, Kumamoto

902-8511

Naha City Hospital, Naha

319-1113

National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research, Naka-gun

964-8501

Japan Community Health care Organization Nihonmatsu hospital, Nihonmatsu

559-0012

Social Corporation Keigakukai Minamiosaka Hosupital, Osaka

377-0280

National Hospital Organaization Shibukawa Medical Center, Shibukawa

140-8522

Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai, Shinagawa City

985-8506

Saka General Hospital, Shiogama

420-8630

Local incorporated administrative agency Shizuoka City Shizuoka Hospital, Shizuoka

962-8503

Iwase General Hospital, Sukagawa

162-0052

Center Hospital of the National Center for Global Health and Medicine, Tokyo

832-0059

Nagata Hospital; Department of pulmonary medicine, Yanagawa-shi

2333 ZA

Leids Universitair Medisch Centrum; C5-P Stafcentrum Hartziekten, Leiden

6532 SZ

Canisius Wilhelmina Ziekenhuis; Department Hematology, Nijmegen

3083 AN

Ikazia Ziekenhuis, Rotterdam

6162 BG

Zuyderland Medisch Centrum - Sittard Geleen, Sittard-Geleen

3584 CX

Universitair Medisch Centrum Utrecht, Utrecht

Callao 02

Hospital Alberto Sabogal Sologuren, Callao

08006

Hospital Nacional Adolfo Guevara Velasco - ESSALUD; Servicio de Cardiología, Cusco

02841

Korea University Anam Hospital, Seoul

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

06973

ChungAng University Hospital, Seoul

07441

Hallym University Kangnam Sacred Heart Hospital, Seoul

08916

Hospital Universitario Germans Trias i Pujol, Badalona

08950

Hospital Sant Joan de Deu - PIN; Unitat de Recerca - Farmacia, Esplugues de Llobregat

08221

Hospital Mutua de Terrassa, Terrassa

03010

Hospital General Universitario de Alicante, Alicante

08003

Hospital del Mar, Barcelona

08035

Hospital Universitario Vall d'Hebron - PPDS, Barcelona

413 45

Sahlgrenska Universitetssjukhuset, Gothenburg

SE-20502

Skånes Universitetssjukhus Malmö; Infektionskliniken, Malmo

06100

Hacettepe University Medical Faculty, Ankara

07059

Akdeniz University Medical Faculty, Antalya

01601

Kyiv Oleksandrivska Clinical Hospital; Infectious Box Department #2, Kyiv

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03684044 - Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza | Biotech Hunter | Biotech Hunter