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

NCT03969212 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: MV406182018-004056-37
• Study Type: interventional
• Target: 4,138
• Locations: 16 countries
• Sites: 142

Brief Summary

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Percentage of HHCs With Virological Influenza Transmission by Day 5

  The virological transmission was determined based on Polymerase Chain Reaction Positive (PCR+) influenza test results. The adjusted incidence (cumulative proportion of events by Day 5) rate is reported here. This is defined as percentage of HHCs who tested PCR+ for influenza by Day 5 post IP randomization with virus subtype matching with that of the respective IP, irrespective of being symptomatic or asymptomatic. The adjusted incidence rates presented were estimated using a generalized estimating equations (GEE) approach.

  Baseline (Day 1) to Day 5

Secondary Outcomes (11)

• Percentage of HHCs With Symptomatic Influenza Transmission by Day 5

  Baseline (Day 1) to Day 5

• Percentage of Households (HHs) With Virological Influenza Transmission at Household Level by Day 5

  Baseline (Day 1) to Day 5

• Percentage of HHs With Symptomatic Influenza Transmission at Household Level by Day 5

  Baseline (Day 1) to Day 5

• Percentage of HHCs With Virological Influenza Transmission by Day 9

  Baseline (Day 1) to Day 9

• Percentage of HHCs With Symptomatic Influenza Transmission by Day 9

  Baseline (Day 1) to Day 9

Study Arms (2)

Baloxavir Marboxil

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Participants who are IPs will receive a single oral dose of placebo. HHCs of the IPs will not receive study medication.

Drug: Placebo

Interventions

Baloxavir Marboxil DRUG

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.

Also known as: Xofluza

Baloxavir Marboxil

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 5 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (142)

Cahaba Research, Inc.

Birmingham, Alabama, 35235, United States

Location

Cahaba Research, Inc

Pelham, Alabama, 35124, United States

Location

Precision Trials

Phoenix, Arizona, 85032, United States

Location

Hope Clinical Research

Canoga Park, California, 91303, United States

Location

Long Beach Clinical Trials

Long Beach, California, 90806, United States

Location

Downtown LA Research Center

Los Angeles, California, 90017, United States

Location

Probe Clinical Research

Riverside, California, 92501, United States

Location

MD Strategies Research Centers

San Diego, California, 92119, United States

Location

Cherry Creek Family Practice

Denver, Colorado, 80246, United States

Location

Proactive Clinical Research, LLC

Fort Lauderdale, Florida, 33308, United States

Location

Helios Clinical Research, Inc (former Ventavia Research Group)

Kissimmee, Florida, 34744, United States

Location

South Florida Research Center, Inc.

Miami, Florida, 33135, United States

Location

Cordova Research Institute, LLC

Miami, Florida, 33155, United States

Location

Research Institute of South Florida Inc

Miami, Florida, 33173, United States

Location

Kendall South Medical Center Inc.

South Miami, Florida, 33185, United States

Location

Agile Clinical Research Trials

Atlanta, Georgia, 30328, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

Location

Mishawaka Osteopathic Clinic

Mishawaka, Indiana, 46544, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Mercury Street Medical Group

Butte, Montana, 59701, United States

Location

Montana Medical Research LLC

Missoula, Montana, 59808, United States

Location

Accent Clinical Trials

Las Vegas, Nevada, 89104, United States

Location

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

Location

OnSite Clinical Solutions LLC

Charlotte, North Carolina, 28277, United States

Location

Burke Primary Care

Morganton, North Carolina, 28655, United States

Location

Hometown Urgent Care and Occupational Health - Springdale

Cincinnati, Ohio, 45215, United States

Location

Tristar Clinical Investigations

Philadelphia, Pennsylvania, 19114, United States

Location

Frontier Clinical Research

Scottdale, Pennsylvania, 15683, United States

Location

Frontier Clinical Research

Smithfield, Pennsylvania, 15478, United States

Location

Frontier Clinical Research

Smithfield, Pennsylvania, 26505, United States

Location

Jedda Enterprises dba Galen Clinical Research

Greer, South Carolina, 29651, United States

Location

AFC Urgent Care-Gunbarrell

Chattanooga, Tennessee, 37421, United States

Location

Helios Clinical Research, Inc (former Ventavia Research Group)

Jackson, Tennessee, 38305, United States

Location

City Doc Urgent Care-Dallas/Ft. Worth

Dallas, Texas, 75204, United States

Location

Southwest Family Medicine Associates

Dallas, Texas, 75235, United States

Location

Premier Pulmonary Critical Care and Sleep Medicine

Denison, Texas, 75020, United States

Location

Pioneer Research Solutions

Houston, Texas, 077099, United States

Location

Vilo Research Group

Houston, Texas, 77017, United States

Location

Fairway Medical Clinic

Houston, Texas, 77087, United States

Location

Mercury Clinical Research

Houston, Texas, 77087, United States

Location

Family Practice Center

McAllen, Texas, 78501, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

Frontier Clinical Research

Kingwood, West Virginia, 26537, United States

Location

Medical Centre "Asklepii", OOD

Dupnitsa, 2600, Bulgaria

Location

Medical Center Hera Eood

Montana, 3400, Bulgaria

Location

MHAT Sveta Paraskeva

Pleven, 5800, Bulgaria

Location

Medizinski Zentrar-1-Sevlievo EOOD

Sevlievo, 5400, Bulgaria

Location

MHAT Sliven - Military Medial Academy

Sliven, 8800, Bulgaria

Location

Medical Center Hera Sofia

Sofia, 1510, Bulgaria

Location

MHAT Sveta Sofia

Sofia, 1618, Bulgaria

Location

Capital Medical University Beijing Hospital of Traditional Chinese Medicine

Beijing, 100010, China

Location

Beijing You An Hospital

Beijing, 100069, China

Location

China-Japan Friendship Hospital

Beijing, 10029, China

Location

Beijing Tsinghua Changgung Hospital

Beijing, 102218, China

Location

West China Hospital, Sichuan University

Chengdu, 610041, China

Location

The Third People's Hospital of Hainan Province

Sansha, 572000, China

Location

Shenzhen People's Hospital

Shenzhen, 510852, China

Location

Shenzhen children's hospital

Shenzhen, 518038, China

Location

Taizhou People's Hospital

Taizhou, 225309, China

Location

The First Affiliated Hospital of Wenzhou Medical College

Wenzhou, 325000, China

Location

General Hospital of Ningxia Medical University

Yinchuan, 750004, China

Location

Henan Provincial People's Hospital

Zhengzhou, 450003, China

Location

ICIMED Instituto de Investigación en Ciencias Médicas

San José, 10108, Costa Rica

Location

Laiko General Hospital - Uni of Athens

Athens, 115 27, Greece

Location

Sotiria General Hospital of Athens

Athens, 115 27, Greece

Location

Attikon University General Hospital

Chaïdári, 124 62, Greece

Location

Obudai Egeszsegugyi Centrum Kft.

Budapest, 1036, Hungary

Location

II. Háziorvosi Körzet

Hosszúhetény, 7694, Hungary

Location

Gyermekháziorvosi rendel?- Dr. Újhelyi János

Nyíregyháza, 4400, Hungary

Location

OEC Clinical Research

Zalaegerszeg, 8900, Hungary

Location

JSS Hospital

Mysuru, Karnataka, 570004, India

Location

Kiryat Motzkin Maccabi Medical Center

Kiryat Motzkin, Israel

Location

Maccabi health services - Moked Hashalom

Tel Aviv, 6789140, Israel

Location

Toda Internal Medicine & Neurology Clinic

Akashi, 674-0081, Japan

Location

Medical Corporation Houmankai?Umezu?Clinic

Chikushino-shi, 818-0024, Japan

Location

Shin Komonji Hospital

Fukuoka, 800-0057, Japan

Location

Irie Naika Syounika Iin

Fukuoka, 812-0053, Japan

Location

Kimura Siro Clinic

Fukuoka, 819-0022, Japan

Location

Iguchi Clinic

Fukuyama, 720-0825, Japan

Location

Mashiba Clinic

Hannō, 357-0024, Japan

Location

Fujimaki Ent Clinic

Ichikawa, 272-0143, Japan

Location

Hisaki Family Clinic

Ichikawa, 272-0805, Japan

Location

Moriyama Otolaryngology

Kagoshima, 890-0034, Japan

Location

Kamoike ENT Allergy Clinic

Kagoshima, 890-0063, Japan

Location

Clinic Kashiwanoha

Kashiwa, 277-0882, Japan

Location

Kamezawa Clinic

Kasugai, 486-0817, Japan

Location

Oishi Clinic

Kasuyagun, 811-2310, Japan

Location

Takahashi naika

Kawasaki, 211-0041, Japan

Location

Kanagawa Himawari Clinic

Kawasaki, 216-0006, Japan

Location

Osaki Internal and Respiratory Clinic,

Kitakyushu, 802-0083, Japan

Location

Morizono medical clinic

Kitakyushu, 807-0072, Japan

Location

Sato ENT Clinic

Kitakyushu, 807-0856, Japan

Location

Kiheibashi Otolaryngology

Kodaira, 187-0044, Japan

Location

Medical corporation Shirayurikai Swing Nozaki Clinic

Musashino, 180-0022, Japan

Location

Yaesu Clinic

Naha, 900-0032, Japan

Location

Horikawa Clinic

Nonoichi, 921-8801, Japan

Location

Lee's Clinic

Osaka, 531-0073, Japan

Location

Kitada Clinic

Osaka, 538-0044, Japan

Location

Sunami Internal medicine Clinic

Osaka, 538-0044, Japan

Location

Funai Ear Nose Throat Clinic

Ōita, 870-0021, Japan

Location

Saga Memorial Hospital

Saga, 849-0917, Japan

Location

Segawa Hospital

Saitama, 355-0328, Japan

Location

Uehara Clinic

Sapporo, 006-0031, Japan

Location

Aiiku Hospital

Sapporo, 064-0804, Japan

Location

Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai

Shinagawa City, 140-8522, Japan

Location

Wakasa Clinic

Tokorozawa, 359-1151, Japan

Location

Seiwa Clinic

Tokyo, 123-0845, Japan

Location

Denenchofu Family Clinic

Tokyo, 145-0071, Japan

Location

Sato Clinic

Tokyo, 150-0013, Japan

Location

Sekino Hospital

Toshima City, 171-0014, Japan

Location

Takeru CLINIC

Toyohashi, 440-0834, Japan

Location

Tsuchiura Beryl Clinic

Tsuchiura, 300-0062, Japan

Location

Medical corporation Seijinkai Takei Clinic

Tsuru, 402-0025, Japan

Location

Gushiken-Cardiology and Internal medicine

Urasoe, 901-2102, Japan

Location

Uranishi Clinic

Urasoe, 901-2104, Japan

Location

Yotsukaido Tokushukai Medical Center

Yotsukaidō, 284-0032, Japan

Location

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

Guadalajara, Jalisco, 44130, Mexico

Location

Centro Respiratorio de México

México, Mexico CITY (federal District), 14050, Mexico

Location

Centro de Estudios Clinicos de Queretaro (CECLIQ)

Querétaro City, Querétaro, 76000, Mexico

Location

EME RED

Mérida, Yucatán, 97000, Mexico

Location

Merida | Investigacion Clinica

Mérida, Yucatán, 97125, Mexico

Location

KLIMED

Bialystok, 15-704, Poland

Location

Centrum Medyczne Lukamed Joanna Luka

Chojnice, 89-600, Poland

Location

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

Puławy, 24-100, Poland

Location

CLINHOUSE Sp z o.o.

Zabrze, 41-807, Poland

Location

Fundacion de Investigacion de Diego

San Juan, 00927, Puerto Rico

Location

Into Research

Groenkloof, 0181, South Africa

Location

Newtown Clinical Research

Johannesburg, 2113, South Africa

Location

Langeberg Clinical Trials

Kraaifontein, 7570, South Africa

Location

Midrand Medical Centre

Midrand, 1685, South Africa

Location

Centro de Salud Las Aguilas

Madrid, 28044, Spain

Location

Ankara Bilkent City Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Ankara University Faculty of Medicine Cebeci Hospital

Ankara, 06590, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty

Ankara, 6100, Turkey (Türkiye)

Location

Gazi University Medical Faculty

Ankara, 65000, Turkey (Türkiye)

Location

Akdeniz University Medical Faculty

Antalya, 07059, Turkey (Türkiye)

Location

Atakent Acibadem Private Hosptial Halkali Merkez Mh.,

Istanbul, 34303, Turkey (Türkiye)

Location

Ege University Medical Faculty

Izmir, 35100, Turkey (Türkiye)

Location

Dokuz Eylul University Medical Faculty

Izmir, 35340, Turkey (Türkiye)

Location

Kocaeli University Medical Faculty

Kocaeli, 41380, Turkey (Türkiye)

Location

Karadeniz Technical Uni School of Medicine

Trabzon, 61080, Turkey (Türkiye)

Location

Preston Hill Surgery

Harrow, HA3 9SN, United Kingdom

Location

Related Publications (2)

• Monto AS, Kuhlbusch K, Bernasconi C, Cao B, Cohen HA, Graham E, Hurt AC, Katugampola L, Kamezawa T, Lauring AS, McLean B, Takazono T, Widmer A, Wildum S, Cowling BJ. Efficacy of Baloxavir Treatment in Preventing Transmission of Influenza. N Engl J Med. 2025 Apr 24;392(16):1582-1593. doi: 10.1056/NEJMoa2413156.

  PMID: 40267424 DERIVED

• Komeda T, Takazono T, Hosogaya N, Ogura E, Fujiwara M, Miyauchi H, Ajisawa Y, Iwata S, Watanabe H, Honda K, Kitanishi Y, Hara K, Mukae H. Comparison of Household Transmission of Influenza Virus From Index Patients Treated With Baloxavir Marboxil or Neuraminidase Inhibitors: A Health Insurance Claims Database Study. Clin Infect Dis. 2021 Jun 1;72(11):e859-e867. doi: 10.1093/cid/ciaa1622.

  PMID: 33103200 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

baloxavir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: May 31, 2019
• Study Start: October 10, 2019
• Primary Completion: May 10, 2024
• Study Completion: May 10, 2024
• Last Updated: July 4, 2025
• Results First Posted: April 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

PL (4); IN (1); ME (5); CO (1); CN (12); HU (4); ES (1); IL (2); ZA (4); GR (3); JP (43); BU (7); PR (1); TU (10); GB (1); US (43)