The inhaled corticosteroid budenoside has been shown to shorten recovery time by around 3 days in patients with COVID-19 who are at higher risk of more severe illness and who are being treated in the community.
Budenoside is a widely available and relatively inexpensive drug used to treat asthma and COPD. It was investigated in a large-scale UK trial to identify effective treatments for COVID-19 that can be used in the early stages of the disease in patients outside hospital settings.
For the interim report, a total of 961 patients were randomly assigned to receive inhaled budesonide at home and were compared with 1819 patients randomly assigned to the usual standard of NHS care alone. Of these, 751 people in the budesonide group and 1028 in the usual care group were SARS-CoV-2 positive and included in the primary interim analysis.
Based on the interim analysis using the latest data from 25 March 2021, the results showed the estimated median time to self-reported recovery for inhaled budesonide was 3.011 days shorter compared with usual care. Approximately one third (32%) of those taking inhaled budesonide, compared with 22% in the usual care group, recovered within the first 14 days and remained well at 28 days. Only 8.5% in the budenoside group were hospitalised, compared with 10.3% in the usual care group.
Joint Chief Investigator, Professor Chris Butler, a GP in South Wales and professor of primary care at the University of Oxford’s Nuffield Department of Primary Care Sciences, said: ‘PRINCIPLE has found evidence that a relatively cheap, widely available drug with very few side effects helps people at higher risk of worse outcomes from COVID-19 recover quicker, stay better once recovered, and improves their well-being.’
Co-investigator Professor Richard Hobbs, head of the Nuffield Department of Primary Care Sciences, said: ‘For the first time, we have high-quality evidence of an effective treatment that can be rolled out across the community for people who are at most risk of developing more severe illness from COVID-19. Unlike other proven treatments, budenoside is effective as a treatment at home and during the early stages of the illness. This is a significant milestone for this pandemic.’
The NHS has confirmed that budenoside can now be prescribed for patients with COVID-19 in general practice on a case-by-case basis.
Budenoside works at the site of the virus in the lungs where it is thought to cause the most damage, and is widely recognised as reducing inflammation. Laboratory studies have also found that it reduces viral replication.
PRINCIPLE Trial Collaborative Group. MedXiv, 12 April 2021. https://www.principletrial.org/results