Therapeutic Area: Influenza

Location:  Cleveland, OH; Jackson, TN; Orlando, FL

Sponsor: Genentech, Inc.

PI: Hassan Alzoubi, MD; Melanie Hoppers, MD; Christopher Chappel, MD

Intervention/Treatment: Baloxavir marboxil or placebo

Phase: 3B

Ages: 5-64

Criteria:

• Have influenza symptom onset within 48 hours
  • Fever, cough, sore throat, nasal congestion, headache, feverishness or chills, muscle or joint pain, fatigue)
• Diagnosed with acute influenza infection by the investigator

Compensation: You may be compensated for your time and participation

About: 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 2 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.