Alvesco no better than placebo for alleviating COVID-19 symptoms

Nonhospitalized patients with COVID-19 who received the inhaled glucocorticoid Alvesco had the same recovery time as those who received placebo, data from a phase 3 trial showed.

Alvesco (ciclesonide, Covis Pharma) is approved by the FDA as prophylactic therapy for patients aged 12 years and older with asthma, according to the agency. Systemic corticosteroids are often used in patients with severe COVID-19, but the role of inhaled corticosteroids in patients with mild to moderate COVID-19 “is less clear,” researchers wrote in JAMA Internal Medicine.

“In vitro, ciclesonide has been shown to have antiviral properties against COVID-19 and blocks COVID-19 viral replication,” Brian M. Clemency, DO, a professor in the department of emergency medicine at the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo, and colleagues wrote. “A case series described three elderly patients with hypoxia due to COVID-19 who recovered following treatment with ciclesonide. Clinical trials are needed to determine the effects of ciclesonide on COVID-19 in the clinical setting.”

Clemency and colleagues randomly assigned 400 nonhospitalized patients with COVID-19 (mean age, 43.3 years; 55.3% women; 86.3% white) to a metered dose inhaler that administered 320 g ciclesonide (n = 197) or placebo (n = 203) twice daily.

According to the researchers, the median time until COVID-19-related symptoms were alleviated — which was the trial’s primary efficacy endpoint — was 19 days (95% CI, 14-21) in the ciclesonide cohort and 19 days (95% CI, 16-23) in the placebo cohort. In addition, there was no significant difference in resolution of all COVID-19 symptoms by day 30 (OR = 1.28; 95% CI, 0.84-1.97).

Regarding the trial’s secondary outcomes, there were significantly fewer ED visits and hospital admissions for COVID-19-related reasons in the ciclesonide cohort vs. the placebo cohort (OR = 0.18; 95% CI, 0.04-0.85). All other secondary outcomes — declines in the incidence of other hospital admissions or death, all-cause mortality and COVID-19-related mortality; increases in the percentage of participants with alleviation of COVID-19-related symptoms and time to hospital admission or death compared with placebo in addition to standard supportive care; and alleviation of all COVID-19-related symptoms on the 7th, 14th and 30th days following treatment — were statistically insignificant.

In addition, 11.2% of patients in the ciclesonide cohort and 14.3% of patients in the placebo cohort experienced at least one adverse event during trial. The most common adverse event among both cohorts was dry mouth, followed by headache and oral candidiasis. No patients died during the study.

“Future studies of inhaled steroids are needed to explore their efficacy in patients with a high risk for disease progression and in reducing the incidence of long-term COVID-19 symptoms or post-acute sequelae of SARS-CoV-2,” Clemency and colleagues wrote.

References:

• Clemency BM, et al. JAMA Intern Med. 2021;doi:10.1001/jamainternmed.2021.6759.
• Drug approval package. Omnaris (Ciclesonide) Nasal Spray. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022004s000TOC.cfm#:~:text=Approval%20Date%3A%2010%2F20%2F2006. Accessed Nov. 19, 2021.
• Drug approval package. Alvesco (Ciclesonide) Inhalation Aerosol. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021658s000TOC.cfm. Accessed Nov. 19, 2021.