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

  • STATUS
    Recruiting
  • End date
    Jul 7, 2023
  • participants needed
    3160
  • sponsor
    Hoffmann-La Roche
Updated on 19 October 2022
Investigator
MV40618 https://forpatients.roche.com/
Primary Contact
Centrum Medyczne LUKA MED.Joanna Łuka (0.0 mi away) Contact
+167 other location
fever
PCR test
cough
nasal congestion
headache
sore throat
trivalent influenza vaccine
oseltamivir
peramivir
zanamivir
baloxavir marboxil

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.

Details
Condition Influenza
Treatment Placebo, Baloxavir Marboxil
Clinical Study IdentifierNCT03969212
SponsorHoffmann-La Roche
Last Modified on19 October 2022

Eligibility

Yes No Not Sure

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
Known hypersensitivity to baloxavir marboxil or the drug product excipients
IP previously included in the study
HHC
Pregnant or within 2 weeks post-partum at screening
Immunocompromised
IP is ≥12 years old and unable to swallow tablets (not applicable to IPs 5 to 11 year
olds who will receive oral suspension)
Less than 2 years old
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
HHC previously included in the study
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
IP lives with an HHC who, based on available information, meets the HHC exclusion
criteria
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
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