NCT05170009

Baloxavir in Combination With Oseltamivir in Allogenic Bone Marrow Transplant Recipients With Influenza

Randomized Double-blind, Placebo-controlled Single Center Pilot Study to Evaluate the Efficacy and Safety of Baloxavir in Combination With Oseltamivir in Adult Allogeneic Bone Marrow Transplant Recipients With Influenza

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled pilot study of the efficacy and safety of baloxavir in combination with oseltamivir (standard of care) for the treatment of influenza in allogeneic stem cell transplant patients. Although there are no data about this treatment option currently available, the investigator hypothesizes that combination therapy may be more effective in clearing influenza virus infection and decreasing the rate of emergence of resistant influenza in immunocompromised human hosts.

Detailed description

This is a randomized double-blind placebo-controlled pilot study of the efficacy and safety of baloxavir in combination with oseltamivir (standard of care) for the treatment of influenza in allogeneic stem cell transplant patients. 30 SCT recipients will take part in the study. Participants with be randomly assigned (1:1) to either baloxavir + oseltamivir or baloxavir-matched placebo +oseltamivir. Before randomization, patients will be stratified by hospitalization status and influenza type A (yes/no). Patients in the baloxavir combination arm will receive weight-adjusted baloxavir (40 mg for patients weighing \<80 kg and 80 mg for those weighing ≥80 kg) at baseline and at day 4 and day 7. They will also receive oseltamivir 75 mg twice daily for 10 days. Patients in the baloxavir-matched placebo + oseltamivir arm will receive baloxavir-matched placebo at baseline and at day 3 and day 7and oseltamivir 75 mg twice daily for 10 days.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	Baloxavir Marboxil	Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing \<80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7.
DRUG	Placebo	Placebo at baseline, day 4, and day 7.
DRUG	Oseltamivir	Oseltamivir 75 mg twice daily for 10 days.

Timeline

• Start date: 2022-04-22
• Primary completion: 2024-01-17
• Completion: 2024-02-07
• First posted: 2021-12-27
• Last updated: 2025-02-26
• Results posted: 2025-02-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study