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

March 31, 2024 updated by: Hoffmann-La Roche

A Phase IIIB, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Clinical Efficacy Study of Baloxavir Marboxil for the Reduction of Direct Transmission of Influenza From Otherwise Healthy Patients to Household Contacts

Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screening. Their households are enrolled within 24 hours of randomization if at least 1 household contacts (HHC) have not received influenza vaccine within 6 months of screening and if all HHC screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs, obtained from both IP and HHC up to 9 (+/-1) days post IP randomization, and through the assessment of symptoms.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

3160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Berazategui, Argentina, B1878FNR
        • Withdrawn
        • Sala Alberto Mignaburu
      • Buenos Aires, Argentina, C1426ABP
        • Withdrawn
        • Centro Médico Dra de Salvo
      • San Miguel de Tucuman, Argentina, T4000IAR
        • Withdrawn
        • Investigaciones en Patologias Respiratorias
      • Vicente López, Argentina, B1602DQD
        • Withdrawn
        • CEMER Centro Medico de Enfermedades Respiratorias
  • Brazil
    • MG
      • Belo Horizonte, MG, Brazil, 30150-221
        • Withdrawn
        • Santa Casa de Misericordia; de Belo Horizonte
    • PR
      • Curitiba, PR, Brazil, 80810-050
        • Withdrawn
        • Centro Integrado de Oncologia de Curitiba
    • RS
      • Porto Alegre, RS, Brazil, 90035-000
        • Withdrawn
        • Hospital Moinhos de Vento
    • SP
      • Sao Paulo, SP, Brazil, 01141-020
        • Withdrawn
        • Dr. Consulta
  • Bulgaria
      • Dupnitsa, Bulgaria, 2600
        • Recruiting
        • Medical Centre "Asklepii", OOD; Office of Pulmonology and Phtisiatrics
      • Kozloduy, Bulgaria, 3320
        • Active, not recruiting
        • Medical Center Zdrave 1; Office of Pulmonology and Phtisiatrics
      • Montana, Bulgaria, 3400
        • Completed
        • MEDICAL CENTER HERA EOOD; Office of Pulmonology and Phtisiatrics
      • Montana, Bulgaria, 3400
        • Recruiting
        • MHAT Stamen Iliev AD; Deparment of Infectious Diseases
      • Pleven, Bulgaria, 5800
        • Active, not recruiting
        • MHAT Sveta Paraskeva; Office of Cardiology Diseases
      • Plovdiv, Bulgaria, 4002
        • Withdrawn
        • Medical Center Nevrocentrum; Office of Pulmonology and Phtisiatrics
      • Ruse, Bulgaria, 7002
        • Recruiting
        • SHAT for Pneumo-Phtysiatric Diseases ?Dr. Dimitar Gramatikov?; Dept. of Pulmonology and Phtisiatrics
      • Ruse, Bulgaria, 7002
        • Completed
        • SHAT for Pneumo-Phtysiatric Diseases ?Dr. Dimitar Gramatikov? EOOD; Department of Pneumology
      • Sevlievo, Bulgaria, 5400
        • Active, not recruiting
        • Medizinski Zentrar-1-Sevlievo EOOD; Office of Pulmonology and Phtisiatrics
      • Sliven, Bulgaria, 8800
        • Completed
        • MHAT Sliven - Military Medial Academy; Department of Infectious Diseases
      • Sofia, Bulgaria, 1510
        • Recruiting
        • Medical Center Hera Sofia; Office of Pulmonology and Phtisiatrics
      • Sofia, Bulgaria, 1618
        • Recruiting
        • MHAT Sveta Sofia; Oncology Department
  • Chile
      • Santiago, Chile, 8330074
        • Withdrawn
        • Centro de Cancer Pontificie Universidad Catolica de Chile
      • Santiago, Chile, 8241479
        • Withdrawn
        • Clinica Vespucio
  • China
      • Beijing, China, 100730
        • Withdrawn
        • Beijing Hospital of Ministry of Health
      • Beijing, China, 100011
        • Recruiting
        • Beijing Ditan Hospital
      • Beijing City, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
      • Beijing City, China, 100069
        • Active, not recruiting
        • Beijing You An Hospital; Digestive Dept
      • Beijing City, China, 102218
        • Active, not recruiting
        • Beijing Tsinghua Changgung Hospital
      • Beijing City, China, 100045
        • Active, not recruiting
        • Beijing Children's Hospital, Capital Medical University
      • Beijing City, China, 100010
        • Completed
        • Capital Medical University Beijing Hospital of Traditional Chinese Medicine
      • Chengdu, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
      • Chongqing City, China, 401122
        • Active, not recruiting
        • Childern's Hospital of Chongqing Medical University
      • Guangzhou, China, 510120
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, China, 510623
        • Completed
        • Guangzhou Women and Children's Medical Center
      • Liaocheng City, China, 252000
        • Recruiting
        • Liaocheng People's Hospital
      • Nanjing City, China, 210001
        • Recruiting
        • Children's hospital of Nanjing medical university
      • Sanya, China, 572000
        • Active, not recruiting
        • The Third People's Hospital of Hainan Province
      • Shanghai, China, 201508
        • Withdrawn
        • Shanghai Public Health Clinical Center
      • Shanghai, China, 200032
        • Active, not recruiting
        • Zhongshan Hospital Fudan University
      • Shanghai City, China, 200040
        • Active, not recruiting
        • Huashan Hospital Affiliated to Fudan University
      • Shenzhen, China, 510852
        • Recruiting
        • Shenzhen People's Hospital
      • Shenzhen City, China, 518038
        • Recruiting
        • Shenzhen children's hospital
      • Suzhou, China, 215006
        • Withdrawn
        • First Affiliated Hospital of Soochow University
      • Taizhou City, China, 225309
        • Completed
        • Taizhou People's Hospital; Infectious Diseases
      • Wenzhou, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical College
      • Wuhan City, China, 430030
        • Recruiting
        • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
      • Yinchuan, China, 750004
        • Completed
        • General Hospital of Ningxia Medical University
      • ZIbo, China, 255400
        • Active, not recruiting
        • Zibo Municipal Hospital.
      • Zhengzhou, China, 450003
        • Completed
        • Henan Provincial People's Hospital
  • Costa Rica
      • San José, Costa Rica, 10108
        • Terminated
        • ICIMED Instituto de Investigación en Ciencias Médicas
  • France
      • Argenteuil, France, 95107
        • Withdrawn
        • CH VICTOR DUPOUY; Reanimation Polyvalente
      • LA Tronche, France, 38700
        • Withdrawn
        • CHU de Grenoble - Hôpital André Michallon; Pôle Urgences
      • Nantes, France, 44093
        • Withdrawn
        • CHU Nantes - Hôtel Dieu; Urgences (Unité d'Investigation Clinique)
  • Greece
      • Athens, Greece, 115 27
        • Completed
        • Laiko General Hospital - Uni of Athens; 1St Dept. of Internal Medicine
      • Athens, Greece, 115 27
        • Completed
        • Sotiria General Hospital of Athens; 3rd Department of Internal Medicine
      • Chaidari, Greece, 124 62
        • Completed
        • Attikon University General Hospital; 4th Academic Department of Internal Medicine
  • Hong Kong
      • Hong Kong, Hong Kong, 852
        • Withdrawn
        • Queen Mary Hospital; Uni Dept of Medicine, Division of Gastroenterology
  • Hungary
      • Budapest, Hungary, 1036
        • Completed
        • Obudai Egeszsegugyi Centrum Kft.
      • Budapest, Hungary, 1083
        • Withdrawn
        • Szigony utcai háziorvosi rendel? -Dr. Simon Judit
      • Gyula, Hungary, 5700
        • Withdrawn
        • Háziorvosi praxis
      • Hosszúhetény, Hungary, 7694
        • Completed
        • II. Háziorvosi Körzet
      • Nyíregyháza, Hungary, 4405
        • Withdrawn
        • Borbánya Praxis
      • Nyíregyháza, Hungary, 4400
        • Completed
        • Gyermekháziorvosi rendel?- Dr. Újhelyi János
      • Szentendre, Hungary, 2000
        • Withdrawn
        • Haziorvosi rendelo - Dr. Hasitz Agnes
      • Szigetvár, Hungary, 7900
        • Withdrawn
        • Papp és Társa Bt.
      • Sátoraljaújhely, Hungary, 3980
        • Withdrawn
        • III. Háziorvosi Körzet- Dr. Csomós Katalin
      • Zalaegerszeg, Hungary, 8900
        • Completed
        • OEC Clinical Research
  • India
    • Delhi
      • NEW Delhi Delhi, Delhi, India, 110060
        • Completed
        • Sir Gangaram Hospital
    • Gujarat
      • Ahmedabad, Gujarat, India, 380052
        • Completed
        • Sterling Hospital; Clinical Research Department
      • Gandhi Nagar, Gujarat, India, 382428
        • Active, not recruiting
        • Kanoria Hospital & Research Centre
    • Haryana
      • Gurgaon, Haryana, India, 122001
        • Completed
        • Medanta-The Medicity
    • Karnataka
      • Bangalore South, Karnataka, India, 560076
        • Completed
        • Apollo Hospitals
      • Bangalore South, Karnataka, India, 560099
        • Completed
        • Mazumdar Shaw Medical Centre- A unit of Narayana Hrudayalaya
      • Mysuru, Karnataka, India, 570004
        • Recruiting
        • JSS Hospital; Department of clinical pharmacy
      • Udupi, Karnataka, India, 576104
        • Active, not recruiting
        • Kasturba Medical College and Hospital; Department of Medicine
    • Maharashtra
      • Mumbai, Maharashtra, India, 400008
        • Completed
        • Sir J J Group of Hospitals; Department of Pulmonary Medicine
      • Nagpur, Maharashtra, India, 440012
        • Active, not recruiting
        • Criticare Hospital & Research Institute; Research department
      • Pune, Maharashtra, India, 411057
        • Completed
        • Lifepoint Multispeciality Hospital; Clinical research department.
      • Pune City, Maharashtra, India, 411004
        • Active, not recruiting
        • MTES's Sanjeevan Hospital
      • Pune City, Maharashtra, India, 411001
        • Active, not recruiting
        • Jehangir Clinical development Centre Pvt Ltd.
    • Rajasthan
      • Ajmer, Rajasthan, India, 305001
        • Completed
        • JLN Medical College and Hospital; TB and Chest Department
    • Telangana
      • Gachibowli, Telangana, India, 500032
        • Completed
        • AIG Hospitals
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226005
        • Completed
        • Ajanta Research centre; Research Department
      • Lucknow, Uttar Pradesh, India, 226003
        • Completed
        • M.V Hospital and Research Centre; Research Hall
    • WEST Bengal
      • Kolkata, WEST Bengal, India, 700073
        • Completed
        • Medical College and Hospital- Kolkata
  • Israel
      • Beer Sheva, Israel, 8476109
        • Withdrawn
        • Clalit Yud Aleph clinic
      • Beer-Sheva, Israel, 8425842
        • Active, not recruiting
        • Siaal Research Center for Family Medicine and Primary Care; Clalit Neve Zeev
      • Beer-Sheva, Israel, 8410500
        • Withdrawn
        • Siaal Research Center for Family Medicine and Primary Care; Faculty of Health Sciences
      • Beer-Sheva, Israel, 8477713
        • Withdrawn
        • Siaal Research Center for Family Medicine and Primary Care; Clalit Tet Clinic
      • Kiryat Motzkin, Israel, 6971028
        • Recruiting
        • Kiryat Motzkin Maccabi Medical Center
      • Petach Tikva, Israel, 4931807
        • Active, not recruiting
        • Clalit Health Services- Pediatric Ambulatory Clinic; Pediatric Ambulatory Clinic
      • Ramat Hasharon, Israel, 6971028
        • Withdrawn
        • Maccabi health services - Moked Hashalom; Maccabi health services - Moked Ramat Hasharon
      • Tel Aviv, Israel, 6789140
        • Terminated
        • Maccabi health services - Moked Hashalom
  • Japan
      • Akashi, Japan, 674-0081
        • Recruiting
        • Toda Internal Medicine & Neurology Clinic
      • Chikushino, Japan, 818-0024
        • Recruiting
        • Medical Corporation Houmankai?Umezu?Clinic
      • Date, Japan, 960-0418
        • Completed
        • Kashinoki Internal Medicine Clinic
      • Fukuoka, Japan, 811-0213
        • Recruiting
        • Fukuoka Wajiro Hospital
      • Fukuoka, Japan, 807-0051
        • Recruiting
        • Fukuoka Shin Mizumaki Hospital
      • Fukuoka, Japan, 812-0053
        • Recruiting
        • Irie Naika Syounika Iin
      • Fukuoka, Japan, 819-0022
        • Recruiting
        • Kimura Siro Clinic
      • Fukuoka, Japan, 819-0168
        • Withdrawn
        • Kunisaki Makoto Clinic
      • Fukuoka, Japan, 810?0024
        • Withdrawn
        • Hatakeyama Internal Medicine and Gastroenterology Clinic
      • Fukuoka, Japan, 800-0057
        • Completed
        • Shin Komonji Hospital
      • Fukuyama, Japan, 720-0825
        • Completed
        • Iguchi Clinic
      • Habikino, Japan, 583-0886
        • Withdrawn
        • Shimada Ear, Nose and Throat Clinic
      • Hakodate, Japan, 040-8577
        • Completed
        • Kyoaikai Hospital
      • Hanno, Japan, 357-0024
        • Terminated
        • Mashiba Clinic
      • Himeji, Japan, 670-0942
        • Withdrawn
        • Sawada Internal Medicine / Respiratory Clinic
      • Ichikawa, Japan, 272-0805
        • Recruiting
        • Hisaki Family Clinic
      • Ichikawa, Japan, 272-0143
        • Terminated
        • Fujimaki Ent Clinic
      • Itoshima, Japan, 819-1104
        • Withdrawn
        • Nakamura Cardiovascular Clinic
      • Kagoshima, Japan, 890-0034
        • Active, not recruiting
        • Moriyama Otolaryngology
      • Kagoshima, Japan, 890-0063
        • Active, not recruiting
        • Kamoike ENT Allergy Clinic
      • Kashiwa, Japan, 277-0882
        • Terminated
        • Clinic Kashiwanoha
      • Kasugai, Japan, 486-0817
        • Recruiting
        • Kamezawa Clinic
      • Kasuyagun, Japan, 811-2310
        • Completed
        • Oishi Clinic
      • Kawasaki, Japan, 211-0041
        • Completed
        • Takahashi naika
      • Kawasaki, Japan, 216-0006
        • Active, not recruiting
        • Kanagawa Himawari Clinic
      • Kita, Japan, 114-0023
        • Recruiting
        • Takinogawa Gastroenterology Hosipital
      • Kitakyushu, Japan, 807-0072
        • Recruiting
        • Morizono medical clinic
      • Kitakyushu, Japan, 802-0083
        • Terminated
        • Osaki Internal and Respiratory Clinic,
      • Kitakyushu, Japan, 807-0856
        • Completed
        • Sato ENT Clinic
      • Kochi, Japan, 783-8509
        • Recruiting
        • JA Kochi Hospital
      • Kodaira, Japan, 187-0044
        • Active, not recruiting
        • Kiheibashi Otolaryngology
      • Koganei, Japan, 184-0004
        • Withdrawn
        • Medical Corporation Association KANWAKAI Musashikoganei Clinic
      • Koriyama, Japan, 963-8026
        • Withdrawn
        • Igarashi Internal Medicine Surgery Clinic
      • Musashino, Japan, 180-0022
        • Recruiting
        • Medical corporation Shirayurikai Swing Nozaki Clinic
      • Nagasaki, Japan, 852-8137
        • Withdrawn
        • Tanigawa Clinic
      • Nagoya,, Japan, 461-0027
        • Recruiting
        • Onaka Naika Higashishirakabe Clinic
      • Naha, Japan, 900-0032
        • Terminated
        • Yaesu Clinic
      • Nonoichi, Japan, 921-8801
        • Recruiting
        • Horikawa Clinic
      • Oita, Japan, 870-0021
        • Recruiting
        • Funai Ear Nose Throat Clinic
      • Osaka, Japan, 554-0014
        • Completed
        • Kikumori Ear, Nose and Throat Clinic
      • Osaka, Japan, 531-0073
        • Active, not recruiting
        • Lee's Clinic
      • Osaka, Japan, 533-0001
        • Recruiting
        • Manabe?Clinic
      • Osaka, Japan, 538-0044
        • Terminated
        • Kitada Clinic
      • Osaka, Japan, 538-0044
        • Terminated
        • Sunami Internal medicine Clinic
      • Saga, Japan, 849-0917
        • Recruiting
        • Saga Memorial Hospital
      • Saitama, Japan, 342-0037
        • Completed
        • Medical Corporation Saitadayoshikai Saikatsu Clinic
      • Saitama, Japan, 355-0328
        • Recruiting
        • Segawa Hospital
      • Sakai, Japan, 593-8322
        • Withdrawn
        • Okuda Ent Clinic
      • Sapporo, Japan, 064-0804
        • Terminated
        • Aiiku Hospital
      • Sapporo, Japan, 006-0031
        • Completed
        • Uehara Clinic
      • Sendai, Japan, 980-0871
        • Withdrawn
        • Hachiman Ishikawa internist clinic
      • Sendai, Japan, 981-0907
        • Recruiting
        • Matsuo Kenko Clinic
      • Shinagawa, Japan, 140-8522
        • Completed
        • Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai
      • Soka, Japan, 340-0034
        • Withdrawn
        • Soka sugiura Internal medicine clinic
      • Tokorozawa, Japan, 359-1151
        • Recruiting
        • Wakasa Clinic
      • Tokyo, Japan, 121-0815
        • Withdrawn
        • Yamaichi Building Medical Clinic
      • Tokyo, Japan, 123-0845
        • Recruiting
        • Seiwa Clinic
      • Tokyo, Japan, 140-0001
        • Recruiting
        • Miyazaki RC Clinic
      • Tokyo, Japan, 140-0011
        • Withdrawn
        • Sakayori Clinic
      • Tokyo, Japan, 143-0015
        • Withdrawn
        • Sato Medical Clinic
      • Tokyo, Japan, 150-0013
        • Recruiting
        • Sato Clinic
      • Tokyo, Japan, 154-0024
        • Withdrawn
        • Suzuki internal & circulatory Medical Clinic
      • Tokyo, Japan, 145-0071
        • Completed
        • Denenchofu Family Clinic
      • Toshima, Japan, 171-0014
        • Recruiting
        • Sekino Hospital
      • Toyohashi, Japan, 440-0834
        • Active, not recruiting
        • Takeru CLINIC
      • Tsuchiura, Japan, 300-0062
        • Completed
        • Tsuchiura Beryl Clinic
      • Tsuru, Japan, 402-0025
        • Completed
        • Medical corporation Seijinkai Takei Clinic
      • Urasoe, Japan, 901-2102
        • Recruiting
        • Gushiken-Cardiology and Internal medicine
      • Urasoe, Japan, 901-2104
        • Completed
        • Uranishi Clinic
      • YAO, Japan, 581-0069
        • Withdrawn
        • Mizoguchi Clinic
      • Yokohama, Japan, 226-0025
        • Withdrawn
        • Tamura Medical Clinic
      • Yotsukaido, Japan, 284-0032
        • Completed
        • Yotsukaido Tokushukai Medical Center
  • Mexico
      • Mexico, Mexico, 03720
        • Withdrawn
        • Centro de Investigacion Clínica GRAMEL S.C
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44130
        • Recruiting
        • Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
    • Mexico CITY (federal District)
      • Mexico, Mexico CITY (federal District), Mexico, 14050
        • Recruiting
        • Centro Respiratorio de México
    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 64460
        • Recruiting
        • CEPREP; Hospital Universitario
    • Queretaro
      • Querétaro, Queretaro, Mexico, 76000
        • Recruiting
        • Centro de Estudios Clinicos de Queretaro (CECLIQ)
    • Yucatan
      • Mérida, Yucatan, Mexico, 97125
        • Recruiting
        • Merida | Investigacion Clinica
      • Mérida, Yucatan, Mexico, 97000
        • Recruiting
        • EME RED
  • New Zealand
      • Hamilton, New Zealand, 3200
        • Recruiting
        • Lakeland Clinical Trials Waikato
      • Rotorua, New Zealand, 3010
        • Recruiting
        • Lakeland Clinical Trials Rotorua
      • Wellington, New Zealand, 5018
        • Recruiting
        • Lakeland Clinical Trials Wellington
  • Poland
      • Bia?ystok, Poland, 15-704
        • Completed
        • KLIMED
      • Bia?ystok, Poland, 15-704
        • Withdrawn
        • KLIMED
      • Bydgoszcz, Poland, 85-079
        • Completed
        • NZOZ Vitamed
      • Chojnice, Poland, 89-600
        • Completed
        • Centrum Medyczne Lukamed Joanna Luka
      • Kalisz, Poland, 62-800
        • Completed
        • Anchor Meds - Kalisz
      • Lublin, Poland, 20-400
        • Withdrawn
        • CM Luxmed Sp. z o.o.
      • Lublin, Poland, 20-362
        • Withdrawn
        • KO-MED Centra Kliniczne Lublin II
      • Piaseczno, Poland, 05-500
        • Completed
        • Centrum Medyczne Pulawska SP. z o.o.
      • Piotrków Trybunalski, Poland, 97-300
        • Completed
        • IRMED Osrodek Badan Klinicznych
      • Pu?awy, Poland, 24-100
        • Recruiting
        • KO-MED Centra Kliniczne Sp. z o.o.; Osrodek Badan Klinicznych
      • Warszawa, Poland, 00-892
        • Withdrawn
        • RCMed
      • Zabrze, Poland, 41-807
        • Completed
        • CLINHOUSE Sp z o.o.
      • Zamosc, Poland, 22-400
        • Withdrawn
        • KO-MED Centra Kliniczne Zamosc
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Completed
        • Fundacion De Investigacion de Diego
  • Singapore
      • Singapore, Singapore, 119074
        • Withdrawn
        • National University Hospital
      • Singapore, Singapore, 768898
        • Completed
        • National Healthcare Group Polyclinics- Yishun
  • South Africa
      • Cape Town, South Africa, 7505
        • Withdrawn
        • TREAD Research
      • Cape Town, South Africa, 7130
        • Suspended
        • Somerset West Clinical Trial Unit
      • Germiston, South Africa, 1401
        • Withdrawn
        • GAMA; Clinical Research
      • Groenkloof, South Africa, 0181
        • Active, not recruiting
        • Into Research; Life Groenkloof Hospital Medical Centre
      • Johannesburg, South Africa, 2113
        • Active, not recruiting
        • Newtown Clinical Research
      • Kempton Park, South Africa, 1619
        • Withdrawn
        • Peermed Clinical Trial Centre
      • Kimberley, South Africa, 8301
        • Withdrawn
        • Trident Clinical
      • Kraaifontein, South Africa, 7570
        • Recruiting
        • Langeberg Clinical Trials
      • Midrand, South Africa, 1685
        • Recruiting
        • Midrand Medical Centre
      • Polokwane, South Africa, 0699
        • Withdrawn
        • Metropolitan Clinical Research Institute
      • Pretoria, South Africa, 0002
        • Withdrawn
        • Emmed Research
      • Pretoria, South Africa, 0152
        • Withdrawn
        • Setshaba Research Centre; Clinical Research
      • Soweto, South Africa, 1818
        • Withdrawn
        • Dr As'ad Ebrahim Bhorat; Soweto Clinical Trial Centre
      • Soweto, South Africa, 2013
        • Withdrawn
        • Wits Clinical Research
      • Tabazimbi, South Africa, 0380
        • Recruiting
        • Tsitsikamma Clinical research Initiative
      • Welkom, South Africa, 9460
        • Withdrawn
        • Welkom Clinical Trial Centre
  • Spain
      • Madrid, Spain, 28044
        • Recruiting
        • Centro de Salud Las Aguilas; Medicina General
  • Turkey
      • Ankara, Turkey, 06100
        • Withdrawn
        • Ankara University Medical Faculty
      • Ankara, Turkey, 06500
        • Completed
        • Gazi University Medical Faculty
      • Ankara, Turkey, 6100
        • Withdrawn
        • Hacettepe University Medical Faculty; Infectious Diseases
      • Ankara, Turkey, 06110
        • Withdrawn
        • Diskapi Egitim Ve Arastirma Hastanesi; Infection
      • Ankara, Turkey, 6100
        • Completed
        • Hacettepe University Medical Faculty; Infectious Diseases
      • Ankara, Turkey, 06490
        • Completed
        • Ankara Bilkent City Hospital
      • Ankara, Turkey, 06700
        • Completed
        • Ankara University Faculty of Medicine Cebeci Hospital
      • Antalya, Turkey, 07059
        • Completed
        • Akdeniz University Medical Faculty
      • Istanbul, Turkey, 34303
        • Active, not recruiting
        • Atakent Acibadem Private Hosptial Halkali Merkez Mh.,
      • Istanbul, Turkey, 34010
        • Completed
        • Koc University Medical Faculty; Department of Gynecology & Obstetrics
      • Istanbul, Turkey, 34093
        • Withdrawn
        • Istanbul Uni Istanbul Medical Faculty
      • Izmir, Turkey, 35100
        • Recruiting
        • Ege University Medical Faculty
      • Izmir, Turkey, 35340
        • Recruiting
        • Dokuz Eylul University Medical Faculty; Infection
      • Kocaeli, Turkey, 41380
        • Completed
        • Kocaeli University Medical Faculty
      • Trabzon, Turkey, 61080
        • Recruiting
        • Karadeniz Technical Uni School of Medicine; Infection Diseases & Clinical Mikrobiology Dept
  • United Kingdom
      • Durham, United Kingdom, DH7 0BD
        • Withdrawn
        • The Haven Surgery
      • Ely, United Kingdom, CB7 5JD
        • Withdrawn
        • Staploe Medical Centre
      • Harrow, United Kingdom, HA3 9SN
        • Completed
        • Preston Hill Surgery
      • Plymouth, United Kingdom, PL5 3JB
        • Withdrawn
        • Knowle House Surgery
      • Thornton-Cleveleys, United Kingdom, FY5 2TZ
        • Withdrawn
        • The Village Practice; Thornton Medical Centre
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Completed
        • Central Alabama Research; Pediatrics
      • Birmingham, Alabama, United States, 35235
        • Completed
        • Cahaba Research, Inc.
      • Pelham, Alabama, United States, 35124
        • Completed
        • Cahaba Research, Inc
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Withdrawn
        • Phoenix Clinical
      • Phoenix, Arizona, United States, 85032
        • Completed
        • Precision Trials
      • Tolleson, Arizona, United States, 85353
        • Withdrawn
        • Alliance Urgent Care-Tolleson
      • Tucson, Arizona, United States, 85704
        • Withdrawn
        • Noble Clinical Research
    • Arkansas
      • Harrisburg, Arkansas, United States, 72432
        • Withdrawn
        • Harrisburg Family Medical Center
    • California
      • Canoga Park, California, United States, 91303
        • Completed
        • Hope Clinical Research
      • Huntington Beach, California, United States, 92647
        • Withdrawn
        • Marvel Research, LLC
      • Long Beach, California, United States, 90806
        • Completed
        • Long Beach Clinical Trials
      • Los Angeles, California, United States, 90095
        • Withdrawn
        • UCLA - School of Medicine
      • Los Angeles, California, United States, 90017
        • Completed
        • Downtown LA Research Center
      • Riverside, California, United States, 92501
        • Completed
        • Probe Clinical Research
      • San Diego, California, United States, 92119
        • Completed
        • MD Strategies Research Centers
    • Colorado
      • Denver, Colorado, United States, 80246
        • Withdrawn
        • Cherry Creek Family Practice
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Withdrawn
        • Proactive Clinical Research, LLC
      • Hialeah, Florida, United States, 33012
        • Withdrawn
        • Alternative Research Associates, LLC
      • Kissimmee, Florida, United States, 34744
        • Completed
        • Helios Clinical Research, Inc (former Ventavia Research Group)
      • Kissimmee, Florida, United States, 34744
        • Recruiting
        • Helios Clinical Research, Inc (former Ventavia Research Group)
      • Lake Worth, Florida, United States, 33467
        • Withdrawn
        • Canvas Clinical Research
      • Miami, Florida, United States, 33165
        • Withdrawn
        • Premier Research Associate, Inc
      • Miami, Florida, United States, 33135
        • Completed
        • South Florida Research Center, Inc.
      • Miami, Florida, United States, 33155
        • Completed
        • Cordova Research Institute, LLC
      • Miami, Florida, United States, 33173
        • Completed
        • Research Institute of South Florida Inc
      • Miami, Florida, United States, 33174
        • Withdrawn
        • Florida Research Center
      • Orlando, Florida, United States, 32801
        • Withdrawn
        • CNS Healthcare
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Nemours Children's Hospital; Nemour's Research Institute
      • South Miami, Florida, United States, 33143
        • Completed
        • Kendall South Medical Center Inc.
      • Tampa, Florida, United States, 33607
        • Withdrawn
        • Clinical Trials of Florida LLC
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Withdrawn
        • Agile Clinical Research Trials
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Completed
        • Clinical Research Prime
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Withdrawn
        • MediSphere Medical Research Center, LLC
      • Mishawaka, Indiana, United States, 46544
        • Completed
        • Mishawaka Osteopathic Clinic
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Withdrawn
        • Kentucky Pediatric Research Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70771
        • Withdrawn
        • Urgent Care Clinical Trials at Urgent Care Eleven
    • Massachusetts
      • Springfield, Massachusetts, United States, 01105
        • Withdrawn
        • Claudia T Martorell MD LLC dba The Research Institute
    • Michigan
      • Troy, Michigan, United States, 48085
        • Completed
        • Oakland Medical Research
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • Withdrawn
        • Olive Branch Family Medical Center; Family Medicine
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Completed
        • Washington University School of Medicine
    • Montana
      • Butte, Montana, United States, 59701
        • Completed
        • Mercury Street Medical Group
      • Missoula, Montana, United States, 59808
        • Completed
        • Montana Medical Research LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Completed
        • Excel Clinical Research
      • Las Vegas, Nevada, United States, 89104
        • Completed
        • Accent Clinical Trials
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Completed
        • OnSite Clinical Solutions LLC
      • Morganton, North Carolina, United States, 28655
        • Completed
        • Burke Primary Care
    • Ohio
      • Cincinnati, Ohio, United States, 45215
        • Terminated
        • Hometown Urgent Care and Occupational Health - Springdale
      • Columbus, Ohio, United States, 43214
        • Withdrawn
        • Hometown Urgent Care and Occupational Health - Clintonville
      • Dayton, Ohio, United States, 45409
        • Withdrawn
        • Dayton Clinical Research
      • Dayton, Ohio, United States, 45424
        • Withdrawn
        • Hometown Urgent Care and Research - Dayton
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Completed
        • Tristar Clinical Investigations
      • Smithfield, Pennsylvania, United States, 15478
        • Completed
        • Frontier Clinical Research
    • South Carolina
      • Easley, South Carolina, United States, 29640
        • Withdrawn
        • AFC Urgent Care-Easley
      • Greer, South Carolina, United States, 29651
        • Withdrawn
        • Jedda Enterprises dba Galen Clinical Research
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Withdrawn
        • Health Concepts
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Completed
        • AFC Urgent Care-Gunbarrell
      • Nashville, Tennessee, United States, 37209
        • Withdrawn
        • Urgent Care Clinical Trials at Complete Urgent Care
      • Tullahoma, Tennessee, United States, 37388
        • Withdrawn
        • Pediatric Clinical Trials, LLC
    • Texas
      • Dallas, Texas, United States, 75204
        • Completed
        • City Doc Urgent Care-Dallas/Ft. Worth
      • Dallas, Texas, United States, 75235
        • Completed
        • Southwest Family Medicine Associates
      • Denison, Texas, United States, 75020
        • Withdrawn
        • Premier Pulmonary Critical Care and Sleep Medicine
      • Houston, Texas, United States, 77087
        • Completed
        • Fairway Medical Clinic
      • Houston, Texas, United States, 077099
        • Completed
        • Pioneer Research Solutions
      • Houston, Texas, United States, 77036-3316
        • Completed
        • Mercury Clinical Research
      • Houston, Texas, United States, 77089-6155
        • Withdrawn
        • Coastal Medical Group
      • Houston, Texas, United States, 77017
        • Completed
        • Vilo Research Group
      • McAllen, Texas, United States, 78501
        • Withdrawn
        • Family Practice Center
      • San Antonio, Texas, United States, 78215
        • Completed
        • Sun Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 64 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

INCLUSION CRITERIA:

Index Patients (IPs):

  • Able to comply with the study protocol per investigator judgment.
  • Diagnosed with acute influenza infection by investigator.
  • Polymerase chain reaction [PCR] (+) or Rapid Influenza Diagnostic Test [RIDT] (+) for influenza A/B based on cobas® SARS-CoV-2 and influenza A/B or other point-of-care / local laboratory results.
  • PCR (-) or antigen test (-) for SARS-CoV-2 based on cobas® SARS-CoV-2 and Influenza A/B test or other point-of-care / local laboratory result
  • Presence of (a) fever (>=38.0 °C per tympanic or rectal thermometer; >=37.5 °C per axillary, oral or forehead/temporal thermometer) or (b) any influenza symptoms (cough, sore throat, nasal congestion, headache, feverishness or chills, muscle or joint pain, fatigue).
  • The time interval between the onset of fever or influenza symptoms and the pre-dose examinations is 48 hours or less.
  • IP lives in a household where: (1) No HHC is known to have been diagnosed with influenza or SARS-CoV-2 infection by a healthcare professional (HCP) in the past 4 weeks; (2) All HHCs are expected to meet the key HHC inclusion criteria; (3) >=1 HHCs are expected to participate in the full study who have not received the influenza vaccine within 6 months prior to screening.
  • Women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures specified in the protocol

All HHCs (Part 1):

  • PCR (-) or RIDT (-) based on cobas® SARS-CoV-2 and influenza A/B or other local point-of-care / local laboratory result.
  • PCR (-) or antigen test (-) for SARS-CoV-2 based on cobas® SARS-CoV-2 and Influenza A/B or other POC / local laboratory result.
  • HHC lives with no HHC who will be present in the home at any time during the study and who meets any HHC exclusion criteria.
  • HHC lives with no HHC who does not meet HHC inclusion criteria (part 1).
  • HHC lives in a household where ≥1 HHCs meet all of the following: Start screening within 24 hours after IP randomization; Have NOT received the influenza vaccine within 6 months prior to screening; and Fulfill full study HHC inclusion criteria part 2.

Full study HHCs (part 2) intended for full study must meet the following additional criteria for study entry:

  • Agree to participate in the full study.
  • Able to comply with the study protocol per investigator judgment
  • No influenza symptoms within 7 days prior to screening. Alternatively, mild symptoms are permissible if determined by the investigator to be due to a preexisting condition.
  • Temperature <38.0 °C (tympanic).
  • Will reside in the index patient's house for at least 7 of the next 9 days and will be present for scheduled study visits.
  • Willing and able to measure and record temperature, or have another household member perform the task on his or her behalf. Furthermore, a responsible adult will assume responsibility to oversee or perform this task on behalf of minors.
  • In the 6 months prior to screening: a) Has not been diagnosed with influenza by a healthcare professional b) Has not received BXM, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir, favipiravir or amantadine.
  • Does not have a moderate or worse active infections OR infections requiring systemic (e.g., oral or intravenous) or otherwise internally administered (e.g., inhaled, intrathecal) antibiotic/antiviral/antifungal therapy, (topical therapies for mild external infections allowed).

EXCLUSION CRITERIA:

IPs:

  • IPs with severe influenza virus infection requiring inpatient treatment.
  • IPs judged by the investigator to be at high risk for complications of influenza.
  • IP is ≥12 years old and unable to swallow tablets (not applicable to IPs 5 to 11 year olds who will receive oral suspension).
  • Women who are breastfeeding or have a positive pregnancy test in the pre-dose examinations.
  • IPs with concurrent (non-influenza) infections requiring systemic antimicrobial and/or antiviral therapy at the pre-dose examinations.
  • IPs who have received baloxavir marboxil, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir, favipiravir or amantadine, or an investigational drug, within 30 days or 5 drug-elimination half-lives, whichever is longer, prior to screening.
  • IPs who have received an investigational monoclonal antibody for a viral disease in the last year.
  • Known hypersensitivity to baloxavir marboxil or the drug product excipients.
  • IP previously included in the study
  • IP lives with an HHC who, based on available information, meets the HHC exclusion criteria

HHC:

  • Pregnant or within 2 weeks post-partum at screening.
  • Immunocompromised.
  • Less than 2 years old.
  • Who have received an investigational therapy within the 30 days or 5 drug elimination half-lives, whichever is longer, prior to screening.
  • Diagnosed with influenza or SARS-CoV-2 infection by a healthcare professional in the past 4 weeks.
  • HHC who plans to arrive home after 24 hours post IP randomization to Day 9 and is not willing to be consented as soon as possible upon arrival.
  • HHC previously included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Baloxavir Marboxil
Participants who are IPs will receive a single oral dose of baloxavir marboxil. HHCs of the IPs will not receive study medication.
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.
Other Names:
  • Xofluza
Placebo Comparator: Placebo
Participants who are IPs will receive a single oral dose of placebo. HHCs of the 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Virological Transmission by Day 5
Time Frame: Baseline to Day 5 (5 days)
Defined as the percentage of Household Contacts (HHCs) who become Polymerase Chain Reaction Positive (PCR+) for Influenza by Day 5 post IP randomization. HHCs may be symptomatic or asymptomatic and their virus subtype must match that of the index patient (IP) in their household. The primary efficacy analysis population will consist of all enrolled unvaccinated HHCs of the randomized IPs.
Baseline to Day 5 (5 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptomatic Transmission by Day 5
Time Frame: Baseline to Day 5 (5 days)
Defined as the percentage of HHCs who become PCR+ for Influenza by Day 5 post IP randomization and develop Influenza symptoms at any time during the study. HHCs ≥12 years old were defined symptomatic if (1) Presence of temperature ≥38.0 Celsius and one respiratory symptom (cough, sore throat, nasal congestion) or (2) Presence of one respiratory symptom and one general systemic symptom (headache, feverishness or chills, muscle or joint pain, fatigue), with or without fever. HHCs ≥2 and <12 years old were defined symptomatic if presence of temperature ≥38.0 Celsius and cough, nasal congestion, or rhinorrhea. Note: For HHCs of any age, respiratory or general systemic symptoms had to be either (1) new, or (2) worsened versus baseline with baseline symptoms due to a pre-existing comorbidity. HHCs must have their virus subtype match that of the IP.
Baseline to Day 5 (5 days)
Virological Transmission at the Household Level by Day 5
Time Frame: Baseline to Day 5 (5 days)
Defined as the percentage of households with at least one HHC who meets the primary endpoint.
Baseline to Day 5 (5 days)
Symptomatic Transmission at the Household Level by Day 5
Time Frame: Baseline to Day 5 (5 days)
Defined as the percentage of households with at least one HHC who meets the "Symptomatic transmission by Day 5 endpoint.
Baseline to Day 5 (5 days)
Virological Transmission by Day 9
Time Frame: Baseline to Day 9 (9 days)
Defined as the percentage of HHCs who become PCR+ for Influenza by Day 9 post IP randomization. HHCs must have their virus subtype match that of the IP, and include: (1) all HHC meeting primary endpoint, AND (2) all HHC cases detected after Day 5 Visit meeting the following criteria: (2a) included HHC case is in a household where another HHC has already met the primary endpoint, OR (2b) included HHC case is PCR (+) for influenza bearing an amino acid substitution of isoleucine for another amino acid at position 38 (I38X) in the polymerase acidic (PA) protein, that have been associated with reduced susceptibility to baloxavir marboxil.
Baseline to Day 9 (9 days)
Symptomatic Transmission by Day 9
Time Frame: Baseline to Day 9 (9 Days)
Defined as the percentage of HHCs who meet the "Virological transmission by Day 9" endpoint AND are symptomatic per the definition for symptoms in the "Symptomatic transmission by Day 5" endpoint.
Baseline to Day 9 (9 Days)
Any Virological Infection by Day 9
Time Frame: Baseline to Day 9 (9 Days)
Defined as the percentage of HHCs who become PCR (+) for influenza (confirmed at central laboratory) by Day 9.
Baseline to Day 9 (9 Days)
Any Virological Infection at the Household Level by Day 9
Time Frame: Baseline to Day 9 (9 Days)
Defined as the percentage of households with at least one HHC who meets the "Any virological infection by Day 9" endpoint.
Baseline to Day 9 (9 Days)
Any Symptomatic Infection by Day 9
Time Frame: Baseline to Day 9 (9 Days)
Defined as the percentage of HHCs who meet the "Any virological infection by Day 9" endpoint AND are symptomatic per the definition for symptoms in the "Symptomatic transmission by Day 5" endpoint.
Baseline to Day 9 (9 Days)
Any Symptomatic Infection at the Household Level by Day 9
Time Frame: Baseline to Day 9 (9 Days)
Defined as the percentage of households with at least one HHC who meets the "Any symptomatic infection by Day 9" endpoint.
Baseline to Day 9 (9 Days)
Percentage of IPs With Adverse Events (AEs)
Time Frame: Baseline to Day 9 (for IPs ≥12 years old) and Day 21 (for IPs <12 years old)
Baseline to Day 9 (for IPs ≥12 years old) and Day 21 (for IPs <12 years old)
Percentage of IPs (<= 12 years old) Reporting each Palatability and Acceptability Response
Time Frame: Baseline
The Palatability and Acceptability questionnaire consists of 2 questions: 1) How was the taste of this medicine; 2) Would you be happy to take this medicine again. Response for question (1) will be captured on a Likert scale (1-5) and for question (2) will be either Yes, No, or Not Sure/No Answer.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2019

Primary Completion (Estimated)

May 11, 2024

Study Completion (Estimated)

May 11, 2024

Study Registration Dates

First Submitted

May 29, 2019

First Submitted That Met QC Criteria

May 29, 2019

First Posted (Actual)

May 31, 2019

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 31, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MV40618
  • 2018-004056-37 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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