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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03969212




Registration number
NCT03969212
Ethics application status
Date submitted
29/05/2019
Date registered
31/05/2019
Date last updated
23/05/2024

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
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
Secondary ID [1] 0 0
2018-004056-37
Secondary ID [2] 0 0
MV40618
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Virological Transmission by Day 5
Timepoint [1] 0 0
Baseline to Day 5 (5 days)
Secondary outcome [1] 0 0
Symptomatic Transmission by Day 5
Timepoint [1] 0 0
Baseline to Day 5 (5 days)
Secondary outcome [2] 0 0
Virological Transmission at the Household Level by Day 5
Timepoint [2] 0 0
Baseline to Day 5 (5 days)
Secondary outcome [3] 0 0
Symptomatic Transmission at the Household Level by Day 5
Timepoint [3] 0 0
Baseline to Day 5 (5 days)
Secondary outcome [4] 0 0
Virological Transmission by Day 9
Timepoint [4] 0 0
Baseline to Day 9 (9 days)
Secondary outcome [5] 0 0
Symptomatic Transmission by Day 9
Timepoint [5] 0 0
Baseline to Day 9 (9 Days)
Secondary outcome [6] 0 0
Any Virological Infection by Day 9
Timepoint [6] 0 0
Baseline to Day 9 (9 Days)
Secondary outcome [7] 0 0
Any Virological Infection at the Household Level by Day 9
Timepoint [7] 0 0
Baseline to Day 9 (9 Days)
Secondary outcome [8] 0 0
Any Symptomatic Infection by Day 9
Timepoint [8] 0 0
Baseline to Day 9 (9 Days)
Secondary outcome [9] 0 0
Any Symptomatic Infection at the Household Level by Day 9
Timepoint [9] 0 0
Baseline to Day 9 (9 Days)
Secondary outcome [10] 0 0
Percentage of IPs With Adverse Events (AEs)
Timepoint [10] 0 0
Baseline to Day 9 (for IPs =12 years old) and Day 21 (for IPs <12 years old)
Secondary outcome [11] 0 0
Percentage of IPs (<= 12 years old) Reporting each Palatability and Acceptability Response
Timepoint [11] 0 0
Baseline

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.
Minimum age
5 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/05/2024
Sample size
Target
Accrual to date
Final
4176
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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United States of America
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Tennessee
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Texas
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Bulgaria
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Dupnitsa
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Kozloduy
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Montana
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Pleven
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Bulgaria
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Ruse
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Bulgaria
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Sevlievo
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Bulgaria
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Sliven
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Bulgaria
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Sofia
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China
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Beijing City
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China
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Beijing
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China
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Chengdu
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China
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Guangzhou
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China
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Liaocheng City
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China
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Nanjing City
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China
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Sanya
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Shanghai
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Shenzhen
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Wenzhou
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Wuhan City
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Yinchuan
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Zhengzhou
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China
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ZIbo
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Costa Rica
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San José
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Greece
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Athens
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Greece
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Chaidari
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Budapest
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Hosszúhetény
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Nyíregyháza
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Rajasthan
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Telangana
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India
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Uttar Pradesh
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India
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WEST Bengal
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Israel
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Beer-Sheva
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Israel
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Kiryat Motzkin
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Israel
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Petach Tikva
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Tel Aviv
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Akashi
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Chikushino
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Date
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Fukuoka
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Hanno
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Ichikawa
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Kashiwa
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Sendai
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Toshima
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Toyohashi
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Tsuchiura
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Tsuru
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Urasoe
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Yotsukaido
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Mexico
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Jalisco
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Mexico
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Mexico CITY (federal District)
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Mexico
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Queretaro
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Mexico
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New Zealand
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Hamilton
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New Zealand
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Rotorua
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New Zealand
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Wellington
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Poland
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Bia?ystok
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Bydgoszcz
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Chojnice
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Kalisz
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Piaseczno
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Piotrków Trybunalski
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Pu?awy
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Poland
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Zabrze
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Puerto Rico
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San Juan
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Singapore
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Singapore
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South Africa
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Cape Town
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South Africa
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Groenkloof
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South Africa
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Johannesburg
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South Africa
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Kraaifontein
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South Africa
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Midrand
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Spain
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Madrid
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Turkey
State/province [120] 0 0
Ankara
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Turkey
State/province [121] 0 0
Antalya
Country [122] 0 0
Turkey
State/province [122] 0 0
Istanbul
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Turkey
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Izmir
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Turkey
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Kocaeli
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Turkey
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Trabzon
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United Kingdom
State/province [126] 0 0
Harrow

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03969212
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries