Queensland University of Technology and University of Oxford researchers are centering investigational energies on inhalers as a possible treatment for COVID-19. A study called the STOIC trial has commenced at Churchill Hospital in Oxford. The investigators are evaluating the effectiveness of inhaled corticosteroid therapy compared to standard of care in participants with early COVID-19 illness in reducing COVID-19 related emergency department presentations and/or hospital admissions.
Any breakthrough starts with empirical observation, followed by meticulous tracking and measurement. Hence, Queensland University of Technology professor Dan Nicolau observed that few asthmatics and people with chronic lung disease (COPD) were among the seriously ill in the early points in the pandemic. But why was that? He certainly found it to be strange as with such comorbidities they most certainly faced more risk than less. As it turns out, Professor Nicolau studied at Oxford and in fact was a protégé of Professor Mona Bafahdel, a respiratory physician and the principal investigator for the STOIC trial.
As professor Nicolau explained in a recent press account ,“One explanation for the low numbers was that something these people were doing regularly was protecting them and that, logically, was that they routinely used inhalers for their chronic lung problems.” Perhaps, he pondered, “it may be that the corticosteroid therapy would be given to anyone with a new, dry cough, and while they are awaiting their COVID-19 results.” Thereafter, the research team analyzed and modeled data to reveal that in fact people that are given the inhaler are less likely to become sick.
Another Corticosteroid Connection: RECOVERY Trial & Dexamethasone
The University of Oxford of course recently disclosed promising preliminary results from the separate RECOVERY trial investigating another corticosteroid called dexamethasone in treating COVID-19 patients. Dexamethasone, taken orally rather than inhaled, is used to treat a range of inflammatory-related conditions. Early data from the RECOVERY trial showcased that the drug reduces deaths by one-third among COVID-19 patients who were on ventilators in intensive care units.
The Study Drug: Budesonide
The study drug, Budesonide (Entocort, Pulmicort), provided by AstraZeneca is a medication of the corticosteroid type. It is an economical and widely available as an inhaler, pill, nasal spray and rectal forms. The inhaled form is used in the long-term management of asthma and COPD. The nasal spray is used for allergic rhinitis and nasal polyps. Pill and rectal forms may be used for inflammatory bowel disease, including Crohn’s disease, ulcerative colitis and microscopic colitis.
The STOIC Clinical Trial
Now the research team has been set up to recruit about 500 people for the prominent clinical trial already underway at the Churchill Hospital in the City of Oxford, England. Called the STOIC (SterOids in COVID-19) trial, the investigators are studying whether asthma inhalers given to people with early emergency department presentations and hospital admissions will reduce infection.
Led by University of Oxford Professor Mona Bafahdel and collaborators, including a former QUT Postdoctoral research fellow Dr. Nabil Fadai (now with University of Nottingham) as well as Professor Nicolau and the QUT team including honor student Alexander Hasson who will coordinate STOIC trial data analysis, modeling of pathological mechanisms and building COVID-19 math models to assess use of the clinical trial data for patient treatment optimization. Some patients will be administered the corticosteroid budesonide while others are given a placebo. For more STOIC trial details, see the link.
Professor Mona Bafahdel, MRCP Group Head / PI, Consultant Physician, Fellow, Member of congregation and Supervisor
Professor Dan Nicolau PhD, Associate Professor Dan Nicolau
Call to Action: Positive results could make this a breakthrough trial in that a low cost, available corticosteroid inhaler could help reduce severity of COVID-19. TrialSite News will monitor ongoing. Sign up for the newsletter for updates. Interested in connecting with this trial? The clinical trials manager is Magda Laskawiec-Szkonter.