NCT03969212

Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households

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: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,138 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 5 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2019-10-10
• Primary completion: 2024-05-10
• Completion: 2024-05-10
• First posted: 2019-05-31
• Last updated: 2025-07-04
• Results posted: 2025-04-24

Locations

142 sites across 16 countries: United States, Bulgaria, China, Costa Rica, Greece, Hungary, India, Israel, Japan, Mexico, Poland, Puerto Rico, South Africa, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study