The aim of the study is to assess the efficacy and safety of administering dexamethasone in combination with oseltamivir compared with oseltamivir monotherapy in patients hospitalized with severe influenza (NEWS2 score > 2). To this end, a randomized, double‑blind, multicenter study has been designed. Efficacy will be measured by the speed of clinical recovery (hospital discharge or clinical recovery according to the Clinical Status Scale, Hospital Recovery Scale on day 7), as well as progression of respiratory support requirements or death. The impact of treatment on viral kinetics will be evaluated using a new viral quantification technique based on qPCR normalized to the number of human cells. Adverse events will be monitored, with particular attention to hyperglycemia (assessed through continuous glucose monitoring) and infectious episodes.
A stratified analysis will be performed according to sex and age over 65 years. A sample size of 486 patients has been estimated, who will be recruited across 4 hospitals (with the possibility of expansion).
It is estimated that the annual influenza epidemic causes between 30,000 and 35,000 hospitalizations in our country, with an estimated mortality of 15–20% among hospitalized patients. This results in a substantial direct and indirect healthcare burden, including labor costs due to lost work hours.
During annual influenza epidemics, the surge in hospital admissions represents a major healthcare challenge that pushes the response capacity of many hospitals to its limits. At the same time, the population at risk of developing severe disease (individuals over 65 years of age and those with comorbidities) continues to grow steadily. For all these reasons, the availability of a treatment for hospitalized patients that is more effective than current options—leading to faster clinical recovery, shorter hospital stays, and/or reduced mortality—would have a substantial impact on health outcomes, both at the individual level and for the healthcare system as a whole.
