InfluenzaPhase 3NCT03969212
Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households
A Phase 3 study testing Baloxavir Marboxil in people with Influenza, run by Hoffmann-La Roche at 142 sites in 16 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 64 years
- Conditions the study is for
- Influenza
- What is being tested?
- Baloxavir Marboxil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,138 participants
- Where
- 142 sitesin 16 countries
- Study dates
- 10 Oct 2019to 10 May 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
142 sites in 16 countries.
142 sites in 16 countries
United States43 sites
Agile Clinical Research Trials
Atlanta, Georgia, 30328
Cahaba Research, Inc.
Birmingham, Alabama, 35235
Mercury Street Medical Group
Butte, Montana, 59701
Hope Clinical Research
Canoga Park, California, 91303
OnSite Clinical Solutions LLC
Charlotte, North Carolina, 28277
AFC Urgent Care-Gunbarrell
Chattanooga, Tennessee, 37421
Hometown Urgent Care and Occupational Health - Springdale
Cincinnati, Ohio, 45215
City Doc Urgent Care-Dallas/Ft. Worth
Dallas, Texas, 75204
Southwest Family Medicine Associates
Dallas, Texas, 75235
Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas, 75020
Cherry Creek Family Practice
Denver, Colorado, 80246
Proactive Clinical Research, LLC
Fort Lauderdale, Florida, 33308
Jedda Enterprises dba Galen Clinical Research
Greer, South Carolina, 29651
Pioneer Research Solutions
Houston, Texas, 077099
Vilo Research Group
Houston, Texas, 77017
Fairway Medical Clinic
Houston, Texas, 77087
Mercury Clinical Research
Houston, Texas, 77087
Clinical Research Prime
Idaho Falls, Idaho, 83404
Helios Clinical Research, Inc (former Ventavia Research Group)
Jackson, Tennessee, 38305
Frontier Clinical Research
Kingwood, West Virginia, 26537
Helios Clinical Research, Inc (former Ventavia Research Group)
Kissimmee, Florida, 34744
Accent Clinical Trials
Las Vegas, Nevada, 89104
Excel Clinical Research
Las Vegas, Nevada, 89109
Long Beach Clinical Trials
Long Beach, California, 90806
Downtown LA Research Center
Los Angeles, California, 90017
Family Practice Center
McAllen, Texas, 78501
South Florida Research Center, Inc.
Miami, Florida, 33135
Cordova Research Institute, LLC
Miami, Florida, 33155
Research Institute of South Florida Inc
Miami, Florida, 33173
Mishawaka Osteopathic Clinic
Mishawaka, Indiana, 46544
Montana Medical Research LLC
Missoula, Montana, 59808
Burke Primary Care
Morganton, North Carolina, 28655
Cahaba Research, Inc
Pelham, Alabama, 35124
Tristar Clinical Investigations
Philadelphia, Pennsylvania, 19114
Precision Trials
Phoenix, Arizona, 85032
Probe Clinical Research
Riverside, California, 92501
Sun Research Institute
San Antonio, Texas, 78215
MD Strategies Research Centers
San Diego, California, 92119
Frontier Clinical Research
Scottdale, Pennsylvania, 15683
Frontier Clinical Research
Smithfield, Pennsylvania, 15478
Frontier Clinical Research
Smithfield, Pennsylvania, 26505
Kendall South Medical Center Inc.
South Miami, Florida, 33185
Washington University School of Medicine
St Louis, Missouri, 63110
Japan43 sites
Toda Internal Medicine & Neurology Clinic
Akashi, 674-0081
Medical Corporation Houmankai?Umezu?Clinic
Chikushino-shi, 818-0024
Shin Komonji Hospital
Fukuoka, 800-0057
Irie Naika Syounika Iin
Fukuoka, 812-0053
Kimura Siro Clinic
Fukuoka, 819-0022
Iguchi Clinic
Fukuyama, 720-0825
Mashiba Clinic
Hannō, 357-0024
Fujimaki Ent Clinic
Ichikawa, 272-0143
Hisaki Family Clinic
Ichikawa, 272-0805
Moriyama Otolaryngology
Kagoshima, 890-0034
Kamoike ENT Allergy Clinic
Kagoshima, 890-0063
Clinic Kashiwanoha
Kashiwa, 277-0882
Kamezawa Clinic
Kasugai, 486-0817
Oishi Clinic
Kasuyagun, 811-2310
Takahashi naika
Kawasaki, 211-0041
Kanagawa Himawari Clinic
Kawasaki, 216-0006
Osaki Internal and Respiratory Clinic,
Kitakyushu, 802-0083
Morizono medical clinic
Kitakyushu, 807-0072
Sato ENT Clinic
Kitakyushu, 807-0856
Kiheibashi Otolaryngology
Kodaira, 187-0044
Medical corporation Shirayurikai Swing Nozaki Clinic
Musashino, 180-0022
Yaesu Clinic
Naha, 900-0032
Horikawa Clinic
Nonoichi, 921-8801
Funai Ear Nose Throat Clinic
Ōita, 870-0021
Lee's Clinic
Osaka, 531-0073
Kitada Clinic
Osaka, 538-0044
Sunami Internal medicine Clinic
Osaka, 538-0044
Saga Memorial Hospital
Saga, 849-0917
Segawa Hospital
Saitama, 355-0328
Uehara Clinic
Sapporo, 006-0031
Aiiku Hospital
Sapporo, 064-0804
Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai
Shinagawa City, 140-8522
Wakasa Clinic
Tokorozawa, 359-1151
Seiwa Clinic
Tokyo, 123-0845
Denenchofu Family Clinic
Tokyo, 145-0071
Sato Clinic
Tokyo, 150-0013
Sekino Hospital
Toshima City, 171-0014
Takeru CLINIC
Toyohashi, 440-0834
Tsuchiura Beryl Clinic
Tsuchiura, 300-0062
Medical corporation Seijinkai Takei Clinic
Tsuru, 402-0025
Gushiken-Cardiology and Internal medicine
Urasoe, 901-2102
Uranishi Clinic
Urasoe, 901-2104
Yotsukaido Tokushukai Medical Center
Yotsukaidō, 284-0032
China12 sites
Capital Medical University Beijing Hospital of Traditional Chinese Medicine
Beijing, 100010
Beijing You An Hospital
Beijing, 100069
China-Japan Friendship Hospital
Beijing, 10029
Beijing Tsinghua Changgung Hospital
Beijing, 102218
West China Hospital, Sichuan University
Chengdu, 610041
The Third People's Hospital of Hainan Province
Sansha, 572000
Shenzhen People's Hospital
Shenzhen, 510852
Shenzhen children's hospital
Shenzhen, 518038
Taizhou People's Hospital
Taizhou, 225309
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, 325000
General Hospital of Ningxia Medical University
Yinchuan, 750004
Henan Provincial People's Hospital
Zhengzhou, 450003
Turkey (Türkiye)10 sites
Ankara Bilkent City Hospital
Ankara, 06100
Ankara University Faculty of Medicine Cebeci Hospital
Ankara, 06590
Hacettepe University Medical Faculty
Ankara, 6100
Gazi University Medical Faculty
Ankara, 65000
Akdeniz University Medical Faculty
Antalya, 07059
Atakent Acibadem Private Hosptial Halkali Merkez Mh.,
Istanbul, 34303
Ege University Medical Faculty
Izmir, 35100
Dokuz Eylul University Medical Faculty
Izmir, 35340
Kocaeli University Medical Faculty
Kocaeli, 41380
Karadeniz Technical Uni School of Medicine
Trabzon, 61080
Bulgaria7 sites
Medical Centre "Asklepii", OOD
Dupnitsa, 2600
Medical Center Hera Eood
Montana, 3400
MHAT Sveta Paraskeva
Pleven, 5800
Medizinski Zentrar-1-Sevlievo EOOD
Sevlievo, 5400
MHAT Sliven - Military Medial Academy
Sliven, 8800
Medical Center Hera Sofia
Sofia, 1510
MHAT Sveta Sofia
Sofia, 1618
Mexico5 sites
Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
Guadalajara, Jalisco, 44130
EME RED
Mérida, Yucatán, 97000
Merida | Investigacion Clinica
Mérida, Yucatán, 97125
Centro Respiratorio de México
México, Mexico CITY (federal District), 14050
Centro de Estudios Clinicos de Queretaro (CECLIQ)
Querétaro City, Querétaro, 76000
Hungary4 sites
Obudai Egeszsegugyi Centrum Kft.
Budapest, 1036
II. Háziorvosi Körzet
Hosszúhetény, 7694
Gyermekháziorvosi rendel?- Dr. Újhelyi János
Nyíregyháza, 4400
OEC Clinical Research
Zalaegerszeg, 8900
Poland4 sites
KLIMED
Bialystok, 15-704
Centrum Medyczne Lukamed Joanna Luka
Chojnice, 89-600
KO-MED Centra Kliniczne Sp. z o.o.
Puławy, 24-100
CLINHOUSE Sp z o.o.
Zabrze, 41-807
South Africa4 sites
Into Research
Groenkloof, 0181
Newtown Clinical Research
Johannesburg, 2113
Langeberg Clinical Trials
Kraaifontein, 7570
Midrand Medical Centre
Midrand, 1685
Greece3 sites
Laiko General Hospital - Uni of Athens
Athens, 115 27
Sotiria General Hospital of Athens
Athens, 115 27
Attikon University General Hospital
Chaïdári, 124 62
Israel2 sites
Kiryat Motzkin Maccabi Medical Center
Kiryat Motzkin
Maccabi health services - Moked Hashalom
Tel Aviv, 6789140
Costa Rica1 site
ICIMED Instituto de Investigación en Ciencias Médicas
San José, 10108
About this study
Official title: 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.
- Conditions
- Influenza
- Being tested
- Baloxavir Marboxil, Placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baloxavir MarboxilDrug
Also called Xofluza
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1) to Day 5
Secondary outcomes (11)
Percentage of HHCs With Symptomatic Influenza Transmission by Day 5
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 respective IP, \& developed symptoms at any time during the study. The adjusted incidence rates presented were estimated using a GEE approach. HHCs ≥12 years old were symptomatic if 1. Presence of temperature ≥38.0 Celsius (C) and 1 respiratory symptom (cough, sore throat, nasal congestion) or 2. Presence of 1 respiratory symptom and 1 general systemic symptom (headache, feverishness or chills, muscle or joint pain, fatigue), with/without a fever. HHCs ≥2 and <12 years old were symptomatic if the presence of temperature was ≥38.0°C and had upper respiratory tract infection signs or symptoms (cough, nasal congestion, or rhinorrhea). Symptoms must be either new or have worsened versus baseline in HHC with baseline symptoms due to a preexisting comorbidity.
Measured: Baseline (Day 1) to Day 5
Percentage of Households (HHs) With Virological Influenza Transmission at Household Level by Day 5
Percentage of households with at least one HHC who met the primary endpoint of virological transmission by Day 5 are reported here. 'Number of participants analyzed' is the number of IPs in the PAS-IP set.
Measured: Baseline (Day 1) to Day 5
Percentage of HHs With Symptomatic Influenza Transmission at Household Level by Day 5
Percentage of HHs with at least one HHC who meets the symptomatic transmission by Day 5 endpoint are reported here. 'Number of participants analyzed' is the number of IPs in the PAS-IP set.
Measured: Baseline (Day 1) to Day 5
Percentage of HHCs With Virological Influenza Transmission by Day 9
The adjusted incidence (cumulative proportion of events by Day 9) rate is reported here. This is defined as percentage of HHCs who tested PCR+ for influenza by Day 9 post IP randomization with virus subtype matching with the respective IP, irrespective of being symptomatic or asymptomatic including: 1. all HHC meeting primary endpoint, AND 2. all HHC cases detected after Day 5 meeting the following criteria: 2a. included HHC case was in an HH where another HHC had already met the primary endpoint OR 2b. included HHC case was PCR+ bearing an amino acid substitution of isoleucine for another amino acid at position 38 (I38X) in the polymerase acidic (PA) protein (PA/I38X substitution) or amino acid substitution of threonine to lysine at position 20 in the PA protein for influenza B only (PA/T20K). The adjusted incidence rates presented were estimated using a GEE approach.
Measured: Baseline (Day 1) to Day 9
Percentage of HHCs With Symptomatic Influenza Transmission by Day 9
The adjusted incidence (cumulative proportion of events by Day 9) rate is reported here. This is defined as percentage of HHCs who met the virological transmission by Day 9 endpoint and developed symptoms at any time during the study. The adjusted incidence rates presented were estimated using a GEE approach. HHCs ≥12 years were symptomatic if they had 1. temperature ≥38.0°C and one respiratory symptom (cough, sore throat, nasal congestion) or 2. one respiratory and one general systemic symptom (headache, feverishness or chills, muscle or joint pain, fatigue), with or without fever. HHCs ≥2 and <12 years were symptomatic if the presence of temperature was ≥38.0°C and had upper respiratory symptoms (headache, feverishness or chills, muscle or joint pain, fatigue). Symptoms must be either new or have worsened versus baseline in HHC with baseline symptoms due to a preexisting comorbidity.
Measured: Baseline (Day 1) to Day 9
Percentage of HHCs With Any Virological Infection by Day 9
Virological infection was defined as HHCs who tested PCR+ for influenza by Day 9 post IP randomization based on PCR influenza test results. The adjusted incidence (cumulative proportion of events by Day 9) rate is reported here. This is defined as percentage of HHCs who met the virological infection by Day 9 endpoint. The adjusted incidence rates presented were estimated using a GEE approach.
Measured: Baseline (Day 1) to Day 9
Percentage of HHs With Any Virological Infection at HH Level by Day 9
Virological infection at the HH level was defined as the HHs with at least one HHC who met the endpoint of any virological infection by Day 9. 'Number of participants analyzed' is the number of IPs in the PAS-IP set.
Measured: Baseline (Day 1) to Day 9
Percentage of HHCs With Any Symptomatic Infection by Day 9
The adjusted incidence (cumulative proportion of events by Day 9) rate is reported here. This is defined as percentage of HHCs who tested PCR+ for influenza by Day 9 post IP randomization and developed symptoms at any time during the study. The adjusted incidence rates presented were estimated using a GEE approach. HHCs ≥12 years were symptomatic if they had (1) a temperature ≥38.0°C and one respiratory symptom (cough, sore throat, nasal congestion) or (2) one respiratory and one systemic symptom (headache, chills, muscle/joint pain, fatigue), with or without fever. HHCs ≥2 and <12 years were symptomatic if the presence of temperature was ≥38.0°C and had upper respiratory symptoms (cough, nasal congestion, rhinorrhea). Symptoms must be either new or have worsened versus baseline in HHC with baseline symptoms due to a preexisting comorbidity.
Measured: Baseline (Day 1) to Day 9
Percentage of HHs With Any Symptomatic Infection at HH Level by Day 9
Percentage of HHs with at least one HHC who meets the endpoint of any symptomatic infection by Day 9 are reported here. HHCs ≥12 years were symptomatic if they had 1. a temperature ≥38.0°C \&1 respiratory symptom (cough, sore throat, nasal congestion) or 2. 1 respiratory \& 1 systemic symptom (headache, chills, muscle/joint pain, fatigue), with/without fever. HHCs ≥2 \& <12 years were symptomatic if the temperature was ≥38.0°C \& had upper respiratory symptoms (cough, nasal congestion, rhinorrhea). Symptoms must be new or have worsened versus baseline in HHC with baseline symptoms due to preexisting comorbidity. 'Number of participants analyzed' is the number of IPs in the PAS-IP set.
Measured: Baseline (Day 1) to Day 9
Number of IPs With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
Measured: Baseline up to Day 9 (for IPs ≥12 years old) and Day 21 (for IPs <12 years old)
Number of IPs With Serious Adverse Events (SAEs)
A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Measured: Baseline up to Day 9 (for IPs ≥12 years old) and Day 21 (for IPs <12 years old)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start10 Oct 2019
- Primary completion10 May 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4,138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969212
- Sponsor's protocol ID
- MV40618
- Other IDs
- 2018-004056-37, 2018
- Status last verified
- Jul 2025
- First submitted
- 29 May 2019
- Last updated
- 4 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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)
Publications
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.
PubMed 40267424Komeda 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.
PubMed 33103200