COMbination therapy with Baloxavir and Oseltamivir 1 for hospitalized patients with influenza – the pragmatic COMBO 1 Trial
The primary objective is to confirm the hypothesis that combination therapy with oseltamivir and single dose baloxavir will result in shorter Time to Clearance of Viral Shedding (TCVS) by virus titer using qCulture from nasal swabs in hospitalized patients with influenza in comparison with standard oseltamivir monotherapy in a pragmatic clinically relevant trial population. The secondary objective is to obtain further efficacy and safety data to optimize protocol development and sample size calculations for an additional trial that includes addition of corticosteroids (COMBO AC). The overall objective, with further optimization of combination therapy, is to improve clinical outcome and decrease nosocomial and household transmission.C