Inhaled Budesonide Speeds Recovery of Non-hospitalized COVID-19 Patients

STOIC (Steroids in COVID-19) was an open-label, parallel-group, phase 2, randomised controlled study of 146 participants with mild COVID-19 symptoms were included in the study. The researchers randomly assigned the patients to receive budesonide (n=73) or usual care (n=73). They administered budesonide dry powder was delivered using a turbohaler at a dose of 800 μg per actuation and advised participants to take two inhalations twice a day until symptom resolution. The major outcome assessed was COVID-19-related urgent care visit, including emergency department assessment or hospitalisation, analysed for both the per-protocol and intention-to-treat (ITT) populations. The researchers also evaluated the self-reported clinical recovery (symptom resolution), viral symptoms measured using the Common Cold Questionnaire (CCQ) and the InFLUenza Patient-Reported Outcome Questionnaire (FLUPro), body temperature, blood oxygen saturations, and SARS-CoV-2 viral load.

Key findings of the study were:

• Upon evaluation, the researchers found that the primary outcome occurred in ten (14%) of 70 participants in the budesonide group and one (1%) of 69 participants in the usual care group (difference in proportions 0·131).
• Among the ITT population, they noted that the primary outcome occurred in 11 (15%) participants in the usual care group and two (3%) participants in the budesonide group (difference in proportions 0·123).
• They further noted that the clinical recovery was 1day shorter in the budesonide group compared with the usual care group (median 7days in the budesonide group vs 8days in the usual care group).
• They also noted that the proportion of days with a fever in the first 14 days was lower in the budesonide group (2%, SD 6) than the usual care group (8%, SD 18) and the proportion of participants with at least 1 day of fever was lower in the budesonide group when compared with the usual care group.
• Therefore, the requirement of antipyretic medications was fewer in the proportion of days among budesonide group when compared with the usual care group (27% vs 50%).
• They observed fewer participants in the budesonide group had persistent symptoms at days 14 and 28 compared with participants receiving usual care.
• They noted that the mean total score change in the CCQ and FLUPro over 14 days was significantly better in the budesonide group compared with the usual care group.
• They reported that budesonide was safe with five (7%) self-limiting adverse events.

The authors concluded, " Budesonide, an inhaled glucocorticoid, appears to be an effective treatment for early COVID-19 infection, which could be applicable to global healthcare systems."

For further information:

https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00160-0/fulltext