In 2020, we learned that for patients on ventilators, Dexamethasone was shown to reduce mortality by about one third, and for patients requiring only oxygen, mortality was cut by about one fifth.
Dexamethasone is a corticosteroid used in a wide range of conditions for its anti-inflammatory and immunosuppressant effects.
Now another corticosteroid, inhaled budesonide often used for Crohn’s disease, was tied to a shorter recovery time in COVID-19 patients who were at a higher risk of severe infection, according to a study published in The Lancet.
The researchers used UK residents 65 or older or who were 50 and older with comorbidities who were enrolled in the larger PRINCIPLE trial. Patients were unwell with suspected COVID-19 for up to 14 days (median, 6 days), and were randomized to budesonide from Nov 27, 2020, to Mar 31, 2021.
In the primary analysis group, 787 received budesonide and usual care, 1,069 received usual care, and 974 were part of other treatment groups. None were hospitalized prior to the assignment.
The budesonide group self-reported a shorter time to recovery (median, 2.94 days; 11.8 vs 14.7 days). And, although hospital admission and death data were too small for the prespecified superiority threshold, the researchers had enough data to model that budesonide may lead to less hospitalization and death (6.8% vs 8.8% model estimate; odds ratio, 0.75).
According to the authors of the study, early on in the COVID-19 pandemic, the low prevalence of asthma and chronic obstructive pulmonary disease among people admitted to hospital with COVID-19 led to speculation that the inhaled corticosteroids used to treat these conditions might be protective.
A related commentary also published in The Lancet by McMaster University’s Dee Mangin, DPH, MBChB, and Michelle Howard, PhD, MSc noted that this link to improved symptom recovery was not seen in the large RECOVERY trial, which enrolled adults with severe COVID-19. They also cautioned that because no placebos were involved, self-reported recovery could be biased.
However, they write, “Various subgroup analyses in PRINCIPLE do not provide any pointers to which particular patient or illness characteristics in the included population might be more likely to predict benefit. These trial data do not support use in younger populations who are at lower risk of complications (<65 years with no comorbidities or anyone <50 years).”*
Dr. Melvin Sanicas (@Vaccinologist) is a physician-scientist specializing in vaccines, infectious diseases, and global health.