Inhaled budesonide in early symptomatic COVID-19 reduced need for urgent care
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Inhaled budesonide twice daily administered early in the course of COVID-19 reduced the need for urgent medical care, according to results of the STOIC trial presented at the virtual European Respiratory Society International Congress.
“Treatments to prevent deterioration from COVID-19 are urgently needed, especially with the vaccination programs in Western countries,” Sanjay Ramakrishnan, MD, pulmonologist and clinical research fellow in the Nuffield department of clinical medicine at the University of Oxford, U.K., said during a presentation.
The randomized, open-label STOIC trial included 146 adults with chronic respiratory disease and symptoms suggesting COVID-19 infection within the previous 7 days. Participants were randomly assigned to inhaled budesonide 800 µg twice daily in addition to usual care of antibiotic therapy with paracetamol and ibuprofen (n = 70; mean age, 44 years; 44% women) or usual care alone (n = 69; mean age, 46 years; 41% women).
This study was completed at home by the participants. Participants were instructed to continue budesonide use until COVID-19 symptom resolution or hospitalization. Each participant filled out questionnaires and recorded daily temperatures and blood oxygen saturations.
The primary outcome was COVID-19-related urgent care visit, ED visit or hospitalization within 20 days. Secondary outcomes included time to self-reported recovery, viral symptoms, patient physiology and quantitative polymerase chain reaction (PCR) test as a surrogate for nasal pharyngeal SARS-CoV-2 viral load.
In the intention-to-treat analysis, the primary outcome occurred in 11 (15%) participants in the usual care group compared with two (3%) participants in the budesonide group had a COVID-19-related urgent care visit, ED visit or hospitalization within 20 days (P = .009).
Symptoms resolved faster among participants in the budesonide group compared with the usual care group (median, 7 days vs. 8 days; P = .007).
In addition, researchers observed lower symptom scores at 14 days in the budesonide group compared with the usual care group (2% vs. 8%; P = .051). At days 14 and 28, fewer participants in the budesonide group had persistent COVID-19 symptoms compared with the usual care group (P = .003).
There were no significant differences in blood oxygen levels or nasal viral load at days 7 and 14. There were also no serious adverse events among participants who received inhaled budesonide; five (7%) participants in the budesonide group reported throat pain and pharyngitis.
“These findings have now been replicated through our collaboration with the PRINCIPLE phase 3 study run in general practice in the U.K., which again showed a reduction in use of primary care, secondary care and hospitalizations on top of a shorter time to recovery,” Ramakrishnan said. “We think budesonide can and should be used to reduce COVID-19 hospital burden globally.”