Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households
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.
Timeline
- Start
- 2019-10-10
- Primary completion
- 2024-05-10
- Completion
- 2024-05-10
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo: HHCs vs Baloxavir Marboxil: HHCs; p = 0.013; Adjusted OR (BMX vs Placebo) 0.68 (95.38% CI 0.50 to 0.93); GEE NCT03969212 ↗
paper By day 5, transmission of laboratory-confirmed influenza was significantly lower with baloxavir than with placebo (adjusted incidence, 9.5% vs. 13.4%; PMID 40267424 ↗
release “BLOCKSTONE study reaches primary endpoint of fewer people testing positive for flu, with fever and at least one respiratory symptom” roche.com ↗
release “positive topline results of the Phase III CENTERSTONE study of Xofluza® (baloxavir marboxil), an antiviral, showing a reduction in the transmission of influenza viruses.” gene.com ↗
release “The study met its primary endpoint” gene.com ↗
release “The study met its primary endpoint” roche.com ↗
Publications
- Monto AS, Kuhlbusch K, Bernasconi C, Cao B, Cohen HA, Graham E, Hurt AC, Katugampola L, Kamezawa T, Lauring AS, McLean B, Takazono T, Widmer A, Wildum S, Cowling BJ. Efficacy of Baloxavir Treatment in Preventing Transmission of Influenza. N Engl J Med. 2025 Apr 24;392(16):1582-1593. doi: 10.1056/NEJMoa2413156.
- Komeda T, Takazono T, Hosogaya N, Ogura E, Fujiwara M, Miyauchi H, Ajisawa Y, Iwata S, Watanabe H, Honda K, Kitanishi Y, Hara K, Mukae H. Comparison of Household Transmission of Influenza Virus From Index Patients Treated With Baloxavir Marboxil or Neuraminidase Inhibitors: A Health Insurance Claims Database Study. Clin Infect Dis. 2021 Jun 1;72(11):e859-e867. doi: 10.1093/cid/ciaa1622.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Baloxavir Marboxil | Unknown | 2 mg/kg | Oral |
| Subject | Baloxavir Marboxil | Unknown | 40 mg | Oral |
| Subject | Baloxavir Marboxil | Unknown | 80 mg | Oral |