Results of the phase 3 PRINCIPLE clinical trial published on a preprint server revealed a 3-day faster recovery of COVID-19 symptoms in people at high risk for severe side effects administered a budesonide inhaler. There was also a 2.1% reduction in hospitalization and death. Many other randomized trials have already demonstrated the benefits of systemic corticosteroids for the treatment of people hospitalized with COVID-19. The multicenter, open-label, multi-arm PRINCIPLE trial enrolled people over the age of 65 or people over the age of 50 with a history of comorbidities from May 17, 2020, across the United Kingdom.
All patients were currently positive for COVID-19 infection within the past 14 days. The interim analysis is based on data collected from the start of the trial to March 25, 2021. A total of 4,663 people were enrolled, with 1,032 patients randomly assigned budesonide. About 85.1% had taken a COVID-19 diagnostic test, where 66% were positive. Researchers found that patients taking inhaled budesonide had a faster COVID-19 recovery time by 3 days than patients who only received usual care. People who did follow up in the 28-day follow-up period reported lower hospitalizations in the budesonide group than the usual care group.
Subjective feelings of well-being were higher with patients taking budesonide than people with usual care. Two patients in the budesonide group were admitted to the hospital for severe health complications, but the researchers determined hospitalization was not connected to COVID-19 infection. Based on the results, the researchers suggest the current PRINCIPLE trial results further confirm prior evidence supporting the use of budesonide in patients with COVID-19 infection.
Ref Link: https://doi.org/10.1101/2021.04.10.21254672