COmbination Therapy With Baloxavir and Oseltamivir 1 for Hospitalized Patients With Influenza (The COMBO Trial 1)
This is a randomized, double-blind, placebo-controlled Phase 2-like, investigator-directed trial of hospitalized patients with laboratory confirmed influenza. Eligible and consented patients will be randomly assigned, in a 1:1 ratio, to one of two groups: Group 1, the combination treatment group (oseltamivir and baloxavir); Group 2, the standard treatment group (oseltamivir and placebo).
• Adults \>/= 18 years old
• Laboratory confirmed influenza A and/or B (rapid test or PCR)
• Able to be enrolled, randomized, and dosed with study drug within 8 hours of the decision to admit patient to hospital for treatment of influenza
• Oseltamivir treatment ordered by clinical team AND patient is able to be enrolled:
‣ Prior to the initial dose of oseltamivir OR
⁃ Within 60 minutes after the initial dose of oseltamivir
• Subject or Legally Authorized Representative able to and willing to provide written informed consent
• Able to commit to 30 days of follow up
• Weight \> 40 kg
• SARS-CoV-2 PCR swab sent within 1 week of enrollment