Inhaled Steroid Studied as Potential COVID-19 Treatment

The results of the double-blinded, randomized, controlled study were published last November in JAMA Internal Medicine. Participants were enrolled from June through November 2020.

A total of 400 patients participated from 10 centers throughout the U.S., with about half receiving treatment and half receiving placebo. Forty-seven patients were from the Buffalo area.

Participants treated with ciclesonide did not see faster mitigation of their symptoms — the primary endpoint of the study — than those who received placebo, with both groups seeing resolution of all symptoms on average within 19 days.

For this study, COVID-19 symptoms were defined as cough, dyspnea (shortness of breath), chills, feeling feverish, repeated shaking with chills, muscle pain, headache, sore throat and new loss of taste or smell.

However, patients treated with ciclesonide were less likely to require emergency department care or hospitalization for reasons attributable to COVID-19.

In this study, only 1 percent of patients who received ciclesonide required emergency department care or hospitalization due to COVID-19 compared to 5.4 percent of the patients who received placebo.

This effect on emergency department care and hospitalizations was an important secondary endpoint of the study.

“Our study did not show that ciclesonide relieved symptoms faster,” says Brian Clemency, DO, first author on the paper and professor of emergency medicine, “but the treated group was less likely than those treated with placebo to go to the emergency department or be hospitalized, and that’s significant.”

“Any COVID-19 treatment that can reduce emergency room visits or hospital admissions provides a benefit not just to the patient, but also to the health care system and the community at large,” says Clemency, a physician with UBMD Emergency Medicine, based at Erie County Medical Center.

“This important clinical research is another example of the Jacobs School’s effort in leading the fight against COVID-19 in the Western New York community,” says Allison Brashear, MD, UB’s vice president for health sciences and dean of the Jacobs School. “Any promising treatment options that may benefit patients, and thereby relieve the stress put on our hospitals and health care systems during this pandemic, must be thoroughly investigated.”

While much COVID-19 research has appropriately focused on patients with severe disease, Clemency and his colleagues were interested in studying mild to moderate cases.

He explains that mild to moderate cases of COVID-19 constitute the majority of cases and may be responsible for a significant amount of community spread.

While the study didn’t address which patients, in particular, would benefit from ciclesonide, Clemency notes that the findings suggest that for some patients with mild to moderate COVID-19, this drug may provide a benefit.

“For patients who are at high risk for developing severe COVID-19, ciclesonide may be a low-cost, low-risk treatment that can be taken at home,” he says.

Inhaled corticosteroids have been seen as potentially beneficial in treating COVID-19 because they reduce inflation and target key proteins involved in virus replication.

Ciclesonide is approved for the long-term treatment of asthma as maintenance therapy in patients 12 years of age and older in the U.S. and over 6 years of age in Canada. In vitro studies have shown ciclesonide to block COVID-19 viral replication and to have antiviral properties against COVID-19.

Renoj Varughese, MD, a clinical assistant professor of emergency medicine, is a co-author on the study from the Jacobs School.

Other co-authors are from the following institutions:

• Boston Children’s Hospital, Harvard Medical School
  
• Instat Clinical Research
  
• Medical College of Georgia at Augusta University
  
• Verus Clinical Research Corporation
  
• Wake Forest School of Medicine
  

Funding was provided by Covis Pharma, which manufactures ciclesonide, and UB’s Clinical and Translational Science Institute, through the National Center for Advancing Translational Science and the National Heart, Lung, and Blood Institute of the National Institutes of Health.