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

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Updated on 19 October 2022

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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 Identifier	NCT03969212
Sponsor	Hoffmann-La Roche
Last Modified on	19 October 2022

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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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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

MV40618 https://forpatients.roche.com/

Centrum Medyczne LUKA MED.Joanna Łuka (0.0 mi away) Contact