COVID Drugs: Oxford Randomized Trial Shows That Inhaled Budenosonide Reduces Risk Of COVID-19 Severity And Hospitalization When Used Early
: A new randomized clinical trial conducted by researchers from Nuffield Department of Clinical Medicine, University of Oxford-UK and also involving medical scientists from the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC)-UK, Eynsham Medical Group-UK, White Horse Medical Practice-UK, Imperial College-UK, University of Nottingham-UK and STATMIND-Sweden has found that the common asthma treatment involving inhaled busenosonide reduces the risk of COVID-19 severity and also the need for hospitalization when used early during SARS-CoV-2 infections.
The study findings were published on a preprint server and are currently being peer reviewed. https://www.medrxiv.org/content/10.1101/2021.02.04.21251134v1
Thailand Medical News had covered about the possibility of using inhaled budesonide since July 2020. https://www.thailandmedical.news/news/covid-19-drugs-queensland-university-of-technology-and-oxford-university-exploring-budesonide-inhaler-therapy-for-early-covid-19-patients-in-new-trial
The new randomized trial show that early treatment with the medication commonly used to treat asthma appears to significantly reduce the need for urgent care and hospitalization in people with COVID-19.
Oxford’s STOIC (Steroids in COVID-19 )study found that inhaled budesonide
given to patients with COVID-19 within seven days of the onset of symptoms also reduced recovery time. Budesonide is a corticosteroid used in the long-term management of asthma and chronic obstructive pulmonary disease (COPD).
The study findings from 146 individuals, of whom half took 800 micrograms of the medication twice a day and half were on usual care suggests that inhaled budesonide reduced the relative risk of requiring urgent care or hospitalization by 90% in the 28-day study period. Participants allocated the budesonide inhaler also had a quicker resolution of fever, symptoms and fewer persistent symptoms after 28 days.
Dr Mona Bafadhel , a professor at the University's Nuffield Department of Medicine, who led the trial, told Thailand Medical News, 'There have been important breakthroughs in hospitalized COVID-19 patients, but equally important is treating early disease to prevent clinica
l deterioration and the need for urgent care and hospitalization, especially to the billions of people worldwide who have limited access to hospital care.”
She added, “The vaccine programs are really exciting, but we know that these will take some time to reach everyone across the world. I am heartened that a relatively safe, widely available and well studied medicine such as an inhaled steroid could have an impact on the pressures we are experiencing during the pandemic.”
It was found that multiple early hospital cohorts of COVID-19 showed that patients with chronic respiratory disease were significantly under-represented. The study team had hypothesized that the widespread use of inhaled glucocorticoids was responsible for this finding and tested if inhaled glucorticoids would be an effective treatment for early COVID-19 illness.
The study team conducted a randomized, open label trial of inhaled budesonide, compared to usual care, in adults within 7 days of the onset of mild COVID-19 symptoms. The primary end point was COVID-19-related urgent care visit, emergency department assessment or hospitalization. The trial was stopped early after independent statistical review concluded that study outcome would not change with further participant enrolment.
A total of 146 patients underwent randomization. For the per protocol population (n=139), the primary outcome occurred in 10 participants and 1 participant in the usual care and budesonide arms respectively (difference in proportion 0.131, p=0.004). The number needed to treat with inhaled budesonide to reduce COVID-19 deterioration was 8. Clinical recovery was 1 day shorter in the budesonide arm compared to the usual care arm (median of 7 days versus 8 days respectively, logrank test p=0.007). Proportion of days with a fever and proportion of participants with at least 1 day of fever was lower in the budesonide arm. Fewer participants randomized to budesonide had persistent symptoms at day 14 and day 28 compared to participants receiving usual care.
The study concluded that
early administration of inhaled budesonide reduced the likelihood of needing urgent medical care and reduced time to recovery following early COVID-19 infection.
The trial findings also demonstrated that there was a reduction in persistent symptoms in those who received budesonide.
Lead researcher Dr Sanjay Ramakrishnan from the Nuffield Department of Clinical Medicine-University of Oxford added, “Although not the primary outcome of study, this is an important finding. I am encouraged to see the reduction in persistent symptoms at 14 and 28 days after treatment with budesonide. Persistent symptoms after the initial COVID-19 illness have emerged as a long-term problem. Any intervention which could address this would be a major step forward.”
Dr Sanjay Ramakrishnan is also a senior researcher as the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC), United Kingdom and a Professor at the School of Medical and Health Sciences, Edith Cowan University, Perth, Australia
The clinical trial was inspired by the fact that, in the early days of the pandemic, patients with chronic respiratory disease, who are often prescribed inhaled steroids, were significantly under-represented among those admitted to hospital with COVID-19.
In conclusion, budesonide, a safe inhaled glucorticoid, appears to be an effective treatment for early COVID-19 infection which could be applicable to global healthcare systems.
Studies are also underway exploring inhaled budesonide as a prophylaxis against the COVID-19 disease.
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