Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households

PHASE3CompletedINTERVENTIONAL
Enrollment

4,138

Participants

Timeline

Start Date

October 10, 2019

Primary Completion Date

May 10, 2024

Study Completion Date

May 10, 2024

Conditions
Influenza
Interventions
DRUG

Baloxavir Marboxil

IPs less than 12 years old will receive either 2 mg/kg (if weight less than 20 kg) or 40 mg (if weight more than or equal to 20 kg) of Baloxavir Marboxil as oral suspension. IPs more than or equal to 12 years old will receive either 40 mg (if weight less than 80 kg) or 80 mg (if weight more than or equal to 80 kg) of Baloxavir Marboxil as tablets. HHCs of IPs will not receive study medication.

DRUG

Placebo

IPs less than 12 years old will receive placebo oral suspension and those above 12 years will receive placebo tablets. HHCs of IPs will not receive study medication.

Trial Locations (142)

1036

Obudai Egeszsegugyi Centrum Kft., Budapest

1510

Medical Center Hera Sofia, Sofia

1618

MHAT Sveta Sofia, Sofia

1685

Midrand Medical Centre, Midrand

2113

Newtown Clinical Research, Johannesburg

2600

"Medical Centre Asklepii, OOD", Dupnitsa

3400

Medical Center Hera Eood, Montana

4400

Gyermekháziorvosi rendel?- Dr. Újhelyi János, Nyíregyháza

5400

Medizinski Zentrar-1-Sevlievo EOOD, Sevlievo

5800

MHAT Sveta Paraskeva, Pleven

6100

Hacettepe University Medical Faculty, Ankara

7570

Langeberg Clinical Trials, Kraaifontein

7694

II. Háziorvosi Körzet, Hosszúhetény

8800

MHAT Sliven - Military Medial Academy, Sliven

8900

OEC Clinical Research, Zalaegerszeg

10029

China-Japan Friendship Hospital, Beijing

10108

ICIMED Instituto de Investigación en Ciencias Médicas, San José

14050

Centro Respiratorio de México, México

15478

Frontier Clinical Research, Smithfield

15683

Frontier Clinical Research, Scottdale

19114

Tristar Clinical Investigations, Philadelphia

26505

Frontier Clinical Research, Smithfield

26537

Frontier Clinical Research, Kingwood

28044

Centro de Salud Las Aguilas, Madrid

28277

OnSite Clinical Solutions LLC, Charlotte

28655

Burke Primary Care, Morganton

29651

Jedda Enterprises dba Galen Clinical Research, Greer

30328

Agile Clinical Research Trials, Atlanta

33135

South Florida Research Center, Inc., Miami

33155

Cordova Research Institute, LLC, Miami

33173

Research Institute of South Florida Inc, Miami

33185

Kendall South Medical Center Inc., South Miami

33308

Proactive Clinical Research, LLC, Fort Lauderdale

34303

Atakent Acibadem Private Hosptial Halkali Merkez Mh.,, Istanbul

34744

Helios Clinical Research, Inc (former Ventavia Research Group), Kissimmee

35100

Ege University Medical Faculty, Izmir

35124

Cahaba Research, Inc, Pelham

35235

Cahaba Research, Inc., Birmingham

35340

Dokuz Eylul University Medical Faculty, Izmir

37421

AFC Urgent Care-Gunbarrell, Chattanooga

38305

Helios Clinical Research, Inc (former Ventavia Research Group), Jackson

41380

Kocaeli University Medical Faculty, Kocaeli

44130

Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C., Guadalajara

45215

Hometown Urgent Care and Occupational Health - Springdale, Cincinnati

46544

Mishawaka Osteopathic Clinic, Mishawaka

59701

Mercury Street Medical Group, Butte

59808

Montana Medical Research LLC, Missoula

61080

Karadeniz Technical Uni School of Medicine, Trabzon

63110

Washington University School of Medicine, St Louis

65000

Gazi University Medical Faculty, Ankara

75020

Premier Pulmonary Critical Care and Sleep Medicine, Denison

75204

City Doc Urgent Care-Dallas/Ft. Worth, Dallas

75235

Southwest Family Medicine Associates, Dallas

76000

Centro de Estudios Clinicos de Queretaro (CECLIQ), Querétaro City

77017

Vilo Research Group, Houston

77087

Fairway Medical Clinic, Houston

Mercury Clinical Research, Houston

78215

Sun Research Institute, San Antonio

78501

Family Practice Center, McAllen

80246

Cherry Creek Family Practice, Denver

83404

Clinical Research Prime, Idaho Falls

85032

Precision Trials, Phoenix

89104

Accent Clinical Trials, Las Vegas

89109

Excel Clinical Research, Las Vegas

90017

Downtown LA Research Center, Los Angeles

90806

Long Beach Clinical Trials, Long Beach

91303

Hope Clinical Research, Canoga Park

92119

MD Strategies Research Centers, San Diego

92501

Probe Clinical Research, Riverside

97000

EME RED, Mérida

100010

Capital Medical University Beijing Hospital of Traditional Chinese Medicine, Beijing

100069

Beijing You An Hospital, Beijing

102218

Beijing Tsinghua Changgung Hospital, Beijing

225309

Taizhou People's Hospital, Taizhou

325000

The First Affiliated Hospital of Wenzhou Medical College, Wenzhou

450003

Henan Provincial People's Hospital, Zhengzhou

510852

Shenzhen People's Hospital, Shenzhen

518038

Shenzhen children's hospital, Shenzhen

570004

JSS Hospital, Mysuru

572000

The Third People's Hospital of Hainan Province, Sansha

610041

West China Hospital, Sichuan University, Chengdu

750004

General Hospital of Ningxia Medical University, Yinchuan

6789140

Maccabi health services - Moked Hashalom, Tel Aviv

077099

Pioneer Research Solutions, Houston

115 27

Laiko General Hospital - Uni of Athens, Athens

Sotiria General Hospital of Athens, Athens

124 62

Attikon University General Hospital, Chaïdári

Unknown

Kiryat Motzkin Maccabi Medical Center, Kiryat Motzkin

674-0081

Toda Internal Medicine & Neurology Clinic, Akashi

818-0024

Medical Corporation Houmankai?Umezu?Clinic, Chikushino-shi

800-0057

Shin Komonji Hospital, Fukuoka

812-0053

Irie Naika Syounika Iin, Fukuoka

819-0022

Kimura Siro Clinic, Fukuoka

720-0825

Iguchi Clinic, Fukuyama

357-0024

Mashiba Clinic, Hannō

272-0143

Fujimaki Ent Clinic, Ichikawa

272-0805

Hisaki Family Clinic, Ichikawa

890-0034

Moriyama Otolaryngology, Kagoshima

890-0063

Kamoike ENT Allergy Clinic, Kagoshima

277-0882

Clinic Kashiwanoha, Kashiwa

486-0817

Kamezawa Clinic, Kasugai

811-2310

Oishi Clinic, Kasuyagun

211-0041

Takahashi naika, Kawasaki

216-0006

Kanagawa Himawari Clinic, Kawasaki

802-0083

Osaki Internal and Respiratory Clinic,, Kitakyushu

807-0072

Morizono medical clinic, Kitakyushu

807-0856

Sato ENT Clinic, Kitakyushu

187-0044

Kiheibashi Otolaryngology, Kodaira

180-0022

Medical corporation Shirayurikai Swing Nozaki Clinic, Musashino

900-0032

Yaesu Clinic, Naha

921-8801

Horikawa Clinic, Nonoichi

531-0073

Lee's Clinic, Osaka

538-0044

Kitada Clinic, Osaka

Sunami Internal medicine Clinic, Osaka

870-0021

Funai Ear Nose Throat Clinic, Ōita

849-0917

Saga Memorial Hospital, Saga

355-0328

Segawa Hospital, Saitama

006-0031

Uehara Clinic, Sapporo

064-0804

Aiiku Hospital, Sapporo

140-8522

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

359-1151

Wakasa Clinic, Tokorozawa

123-0845

Seiwa Clinic, Tokyo

145-0071

Denenchofu Family Clinic, Tokyo

150-0013

Sato Clinic, Tokyo

171-0014

Sekino Hospital, Toshima City

440-0834

Takeru CLINIC, Toyohashi

300-0062

Tsuchiura Beryl Clinic, Tsuchiura

402-0025

Medical corporation Seijinkai Takei Clinic, Tsuru

901-2102

Gushiken-Cardiology and Internal medicine, Urasoe

901-2104

Uranishi Clinic, Urasoe

284-0032

Yotsukaido Tokushukai Medical Center, Yotsukaidō

Yucatán

"Merida , Investigacion Clinica"

15-704

KLIMED, Bialystok

89-600

Centrum Medyczne Lukamed Joanna Luka, Chojnice

24-100

KO-MED Centra Kliniczne Sp. z o.o., Puławy

41-807

CLINHOUSE Sp z o.o., Zabrze

00927

Fundacion de Investigacion de Diego, San Juan

0181

Into Research, Groenkloof

06100

Ankara Bilkent City Hospital, Ankara

06590

Ankara University Faculty of Medicine Cebeci Hospital, Ankara

07059

Akdeniz University Medical Faculty, Antalya

HA3 9SN

Preston Hill Surgery, Harrow

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03969212 - Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households | Biotech Hunter | Biotech Hunter