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

Phase 3

Recruiting

• Conditions: Influenza A and/or B virus infection

• Registration Number: JPRN-jRCT2080224894
• Lead Sponsor: F. Hoffmann-La Roche, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: recruiting
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Index Patients (IPs):
-Diagnosed with acute influenza infection by investigator.
-Polymerase chain reaction [PCR] (+) or Rapid Influenza Diagnostic Test [RIDT] (+) for influenza A/B based on cobas influenza A/B Assay or other point-of-care / local laboratory results.
-Presence of (a) fever (>=38.0 degrees Celsius per tympanic or rectal thermometer; >=37.5 degrees Celsius 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. etc,

All HHCs:
-PCR (-) or RIDT (-) based on cobas influenza A/B Assay or other local point-of-care / local laboratory result at Day 0 Visit. etc,

HHC intended for full study must meet the following additional criteria for study entry:
-No influenza symptoms within 7 days prior to screening. Alternatively, mild symptoms are permissible if determined by the investigator to be due to a pre-existing condition.
-Temperature <38.0 degrees Celsius (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.

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.
-IPs weighing less than 40 kg.
-Known hypersensitivity to baloxavir marboxil or the drug product excipients. etc,

HHC:
-Pregnant or within 2 weeks post-partum at screening.
-Immunocompromised.
-Less than 2 years old. etc,

Study & Design

• Study Type: Interventional
• Study Design: Not specified