Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 2pm (AEST) on Friday 6th June for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
Please note that the ANZCTR will be unattended on Monday 9th June due to an Australian public holiday.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03969212
Registration number
NCT03969212
Ethics application status
Date submitted
29/05/2019
Date registered
31/05/2019
Date last updated
24/04/2025
Titles & IDs
Public title
Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2018-004056-37
Query!
Secondary ID [2]
0
0
MV40618
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Influenza
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Baloxavir Marboxil
Treatment: Drugs - Placebo
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.
Placebo comparator: Placebo - Participants who are IPs will receive a single oral dose of placebo. HHCs of the IPs will not receive study medication.
Treatment: Drugs: 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.
Treatment: Drugs: 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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of HHCs With Virological Influenza Transmission by Day 5
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline (Day 1) to Day 5
Query!
Secondary outcome [1]
0
0
Percentage of HHCs With Symptomatic Influenza Transmission by Day 5
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline (Day 1) to Day 5
Query!
Secondary outcome [2]
0
0
Percentage of Households (HHs) With Virological Influenza Transmission at Household Level by Day 5
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline (Day 1) to Day 5
Query!
Secondary outcome [3]
0
0
Percentage of HHs With Symptomatic Influenza Transmission at Household Level by Day 5
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline (Day 1) to Day 5
Query!
Secondary outcome [4]
0
0
Percentage of HHCs With Virological Influenza Transmission by Day 9
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline (Day 1) to Day 9
Query!
Secondary outcome [5]
0
0
Percentage of HHCs With Symptomatic Influenza Transmission by Day 9
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Baseline (Day 1) to Day 9
Query!
Secondary outcome [6]
0
0
Percentage of HHCs With Any Virological Infection by Day 9
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Baseline (Day 1) to Day 9
Query!
Secondary outcome [7]
0
0
Percentage of HHs With Any Virological Infection at HH Level by Day 9
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Baseline (Day 1) to Day 9
Query!
Secondary outcome [8]
0
0
Percentage of HHCs With Any Symptomatic Infection by Day 9
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Baseline (Day 1) to Day 9
Query!
Secondary outcome [9]
0
0
Percentage of HHs With Any Symptomatic Infection at HH Level by Day 9
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
Baseline (Day 1) to Day 9
Query!
Secondary outcome [10]
0
0
Number of IPs With Adverse Events (AEs)
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Baseline up to Day 9 (for IPs =12 years old) and Day 21 (for IPs <12 years old)
Query!
Secondary outcome [11]
0
0
Number of IPs With Serious Adverse Events (SAEs)
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
Baseline up to Day 9 (for IPs =12 years old) and Day 21 (for IPs <12 years old)
Query!
Eligibility
Key inclusion criteria
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.
Query!
Minimum age
5
Years
Query!
Query!
Maximum age
64
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
10/10/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
10/05/2024
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
4138
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Idaho
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Indiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Missouri
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Montana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Nevada
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
North Carolina
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Ohio
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Pennsylvania
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
South Carolina
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Tennessee
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Texas
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
West Virginia
Query!
Country [19]
0
0
Bulgaria
Query!
State/province [19]
0
0
Dupnitsa
Query!
Country [20]
0
0
Bulgaria
Query!
State/province [20]
0
0
Montana
Query!
Country [21]
0
0
Bulgaria
Query!
State/province [21]
0
0
Pleven
Query!
Country [22]
0
0
Bulgaria
Query!
State/province [22]
0
0
Sevlievo
Query!
Country [23]
0
0
Bulgaria
Query!
State/province [23]
0
0
Sliven
Query!
Country [24]
0
0
Bulgaria
Query!
State/province [24]
0
0
Sofia
Query!
Country [25]
0
0
China
Query!
State/province [25]
0
0
Beijing City
Query!
Country [26]
0
0
China
Query!
State/province [26]
0
0
Beijing
Query!
Country [27]
0
0
China
Query!
State/province [27]
0
0
Chengdu
Query!
Country [28]
0
0
China
Query!
State/province [28]
0
0
Sansha City
Query!
Country [29]
0
0
China
Query!
State/province [29]
0
0
Shenzhen City
Query!
Country [30]
0
0
China
Query!
State/province [30]
0
0
Shenzhen
Query!
Country [31]
0
0
China
Query!
State/province [31]
0
0
Taizhou City
Query!
Country [32]
0
0
China
Query!
State/province [32]
0
0
Wenzhou
Query!
Country [33]
0
0
China
Query!
State/province [33]
0
0
Yinchuan
Query!
Country [34]
0
0
China
Query!
State/province [34]
0
0
Zhengzhou
Query!
Country [35]
0
0
Costa Rica
Query!
State/province [35]
0
0
San José
Query!
Country [36]
0
0
Greece
Query!
State/province [36]
0
0
Athens
Query!
Country [37]
0
0
Greece
Query!
State/province [37]
0
0
Chaidari
Query!
Country [38]
0
0
Hungary
Query!
State/province [38]
0
0
Budapest
Query!
Country [39]
0
0
Hungary
Query!
State/province [39]
0
0
Hosszúhetény
Query!
Country [40]
0
0
Hungary
Query!
State/province [40]
0
0
NyÃregyháza
Query!
Country [41]
0
0
Hungary
Query!
State/province [41]
0
0
Zalaegerszeg
Query!
Country [42]
0
0
India
Query!
State/province [42]
0
0
Karnataka
Query!
Country [43]
0
0
Israel
Query!
State/province [43]
0
0
Kiryat Motzkin
Query!
Country [44]
0
0
Israel
Query!
State/province [44]
0
0
Tel Aviv
Query!
Country [45]
0
0
Japan
Query!
State/province [45]
0
0
Akashi
Query!
Country [46]
0
0
Japan
Query!
State/province [46]
0
0
Chikushino
Query!
Country [47]
0
0
Japan
Query!
State/province [47]
0
0
Fukuoka
Query!
Country [48]
0
0
Japan
Query!
State/province [48]
0
0
Fukuyama
Query!
Country [49]
0
0
Japan
Query!
State/province [49]
0
0
Hanno
Query!
Country [50]
0
0
Japan
Query!
State/province [50]
0
0
Ichikawa
Query!
Country [51]
0
0
Japan
Query!
State/province [51]
0
0
Kagoshima
Query!
Country [52]
0
0
Japan
Query!
State/province [52]
0
0
Kashiwa
Query!
Country [53]
0
0
Japan
Query!
State/province [53]
0
0
Kasugai
Query!
Country [54]
0
0
Japan
Query!
State/province [54]
0
0
Kasuyagun
Query!
Country [55]
0
0
Japan
Query!
State/province [55]
0
0
Kawasaki
Query!
Country [56]
0
0
Japan
Query!
State/province [56]
0
0
Kitakyushu
Query!
Country [57]
0
0
Japan
Query!
State/province [57]
0
0
Kodaira
Query!
Country [58]
0
0
Japan
Query!
State/province [58]
0
0
Musashino
Query!
Country [59]
0
0
Japan
Query!
State/province [59]
0
0
Naha
Query!
Country [60]
0
0
Japan
Query!
State/province [60]
0
0
Nonoichi
Query!
Country [61]
0
0
Japan
Query!
State/province [61]
0
0
Oita
Query!
Country [62]
0
0
Japan
Query!
State/province [62]
0
0
Osaka
Query!
Country [63]
0
0
Japan
Query!
State/province [63]
0
0
Saga
Query!
Country [64]
0
0
Japan
Query!
State/province [64]
0
0
Saitama
Query!
Country [65]
0
0
Japan
Query!
State/province [65]
0
0
Sapporo
Query!
Country [66]
0
0
Japan
Query!
State/province [66]
0
0
Shinagawa
Query!
Country [67]
0
0
Japan
Query!
State/province [67]
0
0
Tokorozawa
Query!
Country [68]
0
0
Japan
Query!
State/province [68]
0
0
Tokyo
Query!
Country [69]
0
0
Japan
Query!
State/province [69]
0
0
Toshima
Query!
Country [70]
0
0
Japan
Query!
State/province [70]
0
0
Toyohashi
Query!
Country [71]
0
0
Japan
Query!
State/province [71]
0
0
Tsuchiura
Query!
Country [72]
0
0
Japan
Query!
State/province [72]
0
0
Tsuru
Query!
Country [73]
0
0
Japan
Query!
State/province [73]
0
0
Urasoe
Query!
Country [74]
0
0
Japan
Query!
State/province [74]
0
0
Yotsukaido
Query!
Country [75]
0
0
Mexico
Query!
State/province [75]
0
0
Jalisco
Query!
Country [76]
0
0
Mexico
Query!
State/province [76]
0
0
Mexico CITY (federal District)
Query!
Country [77]
0
0
Mexico
Query!
State/province [77]
0
0
Queretaro
Query!
Country [78]
0
0
Mexico
Query!
State/province [78]
0
0
Yucatan
Query!
Country [79]
0
0
Poland
Query!
State/province [79]
0
0
Bia?ystok
Query!
Country [80]
0
0
Poland
Query!
State/province [80]
0
0
Chojnice
Query!
Country [81]
0
0
Poland
Query!
State/province [81]
0
0
Pu?awy
Query!
Country [82]
0
0
Poland
Query!
State/province [82]
0
0
Zabrze
Query!
Country [83]
0
0
Puerto Rico
Query!
State/province [83]
0
0
San Juan
Query!
Country [84]
0
0
South Africa
Query!
State/province [84]
0
0
Groenkloof
Query!
Country [85]
0
0
South Africa
Query!
State/province [85]
0
0
Johannesburg
Query!
Country [86]
0
0
South Africa
Query!
State/province [86]
0
0
Kraaifontein
Query!
Country [87]
0
0
South Africa
Query!
State/province [87]
0
0
Midrand
Query!
Country [88]
0
0
Spain
Query!
State/province [88]
0
0
Madrid
Query!
Country [89]
0
0
Turkey
Query!
State/province [89]
0
0
Ankara
Query!
Country [90]
0
0
Turkey
Query!
State/province [90]
0
0
Antalya
Query!
Country [91]
0
0
Turkey
Query!
State/province [91]
0
0
Istanbul
Query!
Country [92]
0
0
Turkey
Query!
State/province [92]
0
0
Izmir
Query!
Country [93]
0
0
Turkey
Query!
State/province [93]
0
0
Kocaeli
Query!
Country [94]
0
0
United Kingdom
Query!
State/province [94]
0
0
Harrow
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Hoffmann-La Roche
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03969212
Query!
Trial related presentations / publications
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.
Query!
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/12/NCT03969212/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/12/NCT03969212/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03969212
Download to PDF