University of Oxford emerges during this pandemic has perhaps the most influential investigational unit worldwide. The recent University of Oxford led STOIC study results reveal that inhaled budesonide, a common asthma treatment, reduces the need for hospitalization for patients tested positive for COVID-19. This 28-day study involved 148 patients: half of them took 800 micrograms of the study drug with trade name Pulmicort (AstraZeneca) twice a day. The study outcomes are promising with the inhaled budesonide actually lowering the probability of urgent care or hospitalization by 90% during the study period. University of Oxford does it again, contributing to the world yet another key piece of medicinal evidence thanks to their ongoing research programs. In the RECOVERY trial, Oxford showed the world that another corticosteroid, dexamethasone, could reduce the COVID-19 death rate for severe to critically ill COVID-19 patients receiving mechanical ventilation versus the standard of care. The prestigious British institution also recently announced the planning of the PRINCIPLE trial as well—the study of ivermectin as yet another promising economical generic to treat COVID-19, at least at early onset.
TrialSite covered the commencement of the STOIC study, which also included Queensland University of Technology (Australia).
The original basis for this study was the observation early on in China during the pandemic that severe cases of COVID-19 for some reason were not as prevalent as expected in patients with chronic lung diseases. Why was this? Could this observation correlate to the use of inhaled corticosteroids? Apparently, some Italian physicians had confirmed this observation. Early microbiological data evidence that corticosteroids are effective at slowing down the rate of COVID-19 replication on lung cells.
Interestingly, early on during the pandemic, TrialSite covered a doctor in West Texas that was administering nebulized budesonide who reported a high percentage of positive outcome among his patients. While the doctors comments were controversial, perhaps he was on to something?
The Study Drug
A corticosteroid, Budesonide is used in the long-term management of asthma and chronic obstructive pulmonary disease (COPD).
As disclosed in clinicaltrials.gov, the 146 participant Phase 2 STOIC study (NCT04416399) sought to test the idea that in participants in the course of COVID-19 illness, a daily high dose of inhaled corticosteroid for 28 days can reduce the chances of severe respiratory illness leading to hospitalization. The investigators at Oxford also sought to investigate the impact of the inhaled therapy on symptoms and viral load. The study, supported by the NIHR Oxford Biomedical Research Center (BRC) and conducted at the Oxford Respiratory Trials Unit, the study was led by Mona Bafadhel, MBBS, PhD.
The study team reports that the inhaled budesonide administered patients diagnosed with COVID-19 within seven days of the onset of symptoms also reduces recovery time. Recently published on the MedRxiv pre-print server, the findings suggest that out of 146 participants, the half that took 800 micrograms of the inhaled budesonide experienced reduction of relative risk of needing urgent care or hospitalization by 90% in the 28—day trial. The patients in this corticosteroid arm of the study also experienced a faster reduction in symptoms after the 28 day study period.
Treatments for Early Onset COVID-19 Urgently Needed
Professor Mona Bafadhel who works in the University of Oxford’s Nuffield Department of Medicine and served as Principal Investigator reports in the University of Oxford press release, “There have been important breakthroughs in hospitalized COVID-19 patients, but equally important is treating early disease to prevent clinical deterioration and the need for urgent care and hospitalization, especially to the billions of people worldwide who have limited access to hospital care.”
Bafadhel continued that although the vaccine programs are not only exciting but necessary, the reality is “…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 inhaled steroid could have an impact on the pressures we are experiencing during the pandemic.”
The study was sponsored by University of Oxford BRC and AstraZeneca.
Professor Mona Bafadhel, MBChB, PhD, FRCP, Chief Investigator
Call to Action: See the study pre-print here. Oxford now contributes another key finding.