The results of the so called STOIC clinical trial run by Oxford University and testing budesonide have just been published as a pre-print on medrxiv.
The study concludes that “Early administration of inhaled budesonide reduced the likelihood of needing urgent medical care and reduced time to recovery following early COVID-19 infection.”
“We have demonstrated that the inhaled glucocorticoid, budesonide, given for a short duration, may be an effective treatment of early COVID-19 disease in adults. This effect, with a relative reduction of 90% of clinical deterioration is equivalent to the efficacy seen following the use of COVID-19 vaccines and greater than that reported in any treatments used in hospitalised and severe COVID-19 patients.”
This is a particularly important result not only because this effectiveness is achieved with a single agent – budesonide – but also because it is achieved on an outpatient basis.
The rationale of this budesonide study is explained in the study’s description:
“Early data from multiple studies in China, where the virus originated, show that severe cases of CoVID-19 are not as prevalent in patients with chronic lung diseases as expected. This is similar to findings from Italy and the US. We think that the widespread use of inhaled corticosteroids may be reducing the risk of severe CoVID-19 infection in patients with chronic lung disease. Early experimental data also shows that inhaled corticosteroids are effective at slowing down the rate of coronavirus replication on lung cells.”
“Inhaled corticosteroids are widely used to manage common lung conditions, such as asthma and chronic obstructive lung disease. This type of medicine is among the top 3 most common medication prescribed around the world. These medicines are safe, the way inhaled steroids work is well understood, and the potential side effects are mild and reversible.”
“We propose to test the idea that, in participants early in the course of CoVID-19 illness, daily inhaled corticosteroids for a maximum of 28 days, will reduce the chances of severe respiratory illness needing hospitalisation. We will also study the effect of this inhaled therapy on physiology, symptoms and the amount of virus that is shed.”
For this study, the authors:
“conducted a randomised, 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 hospitalisation.”
The study only got 146 (out)patients to undergo randomization, yet
“The trial was stopped early after independent statistical review concluded that study outcome would not change with further participant enrolment.”
Note that budesonide has been used for over half a year, off-label, particularly in the US, as discussed by Dr Richard Bartlett and Dr Mobeen Syed in the video referenced below.
Budesonide is also part of the early treatment algorithm developed by Dr Peter McCullough and collaborators.
Watch also this excellent HighWire program with Dr Bartlett.