The inhaled steroid ciclesonide did not reduce the time to alleviation of all symptoms among nonhospitalized participants with symptomatic COVID-19 infection, but researchers still consider the results promising.

The report in JAMA Internal Medicine says that in the randomized clinical trial of 400 patients with symptomatic COVID-19, ciclesonide did not reduce the time to alleviation of all COVID-19-related symptoms, and patients treated with the drug had fewer subsequent emergency department visits or hospital admissions for reasons that were related to COVID-19.

Researchers from the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo write that results of their randomized clinical trial "suggest that 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."

The article notes that systemic corticosteroids are commonly used in treating severe COVID-19; however, whether inhaled corticosteroids have a role generally remains unknown.

That is why the study team sought to determine the efficacy of the inhaled steroid ciclesonide in reducing the time to alleviation of all COVID-19–related symptoms among nonhospitalized participants with symptomatic COVID-19 infection.

The phase lll, multicenter, double-blind, randomized trial was conducted at 10 centers throughout the United States. Researchers assessed the safety and efficacy of a ciclesonide metered-dose inhaler (MDI) for treating nonhospitalized participants–screened from June 11, 2020, to November 3, 2020–with symptomatic COVID-19 infection.

Study participants were randomly assigned to receive ciclesonide MDI, 160 mcg per actuation, for a total of two actuations twice a day (total daily dose, 640 mcg) or a placebo for 30 days.

The primary endpoint was time to alleviation of all COVID-19-related symptoms, including cough, dyspnea, chills, feeling feverish, repeated shaking with chills, muscle pain, headache, sore throat, and new loss of taste or smell by Day 30. Secondary endpoints were subsequent emergency department visits or hospital admissions for reasons attributable to COVID-19.

With 413 participants screened, 400 (96.9%) were enrolled and randomized (197 [49.3%] in the ciclesonide arm and 203 [50.7%] in the placebo arm). The patients had a mean [SD] age of 43.3 years and were 55.3% female. Participants were 0.5% Asian, 11.8% Black or African American, 0.8% Native Hawaiian or other Pacific Islander, 43.0% Hispanic or Latino, and 86.3% White, with one multiracial patient (0.3%).

The authors report that the median time to alleviation of all COVID-19-related symptoms was 19.0 days (95% CI, 14.0-21.0) in the ciclesonide arm and 19.0 days (95% CI, 16.0-23.0) in the placebo arm. No difference was detected in the resolution of all symptoms by day 30 (odds ratio, 1.28; 95% CI, 0.84-1.97). On the other hand, participants who were treated with ciclesonide had fewer subsequent emergency department visits or hospital admissions for reasons related to COVID-19 (odds ratio, 0.18; 95% CI, 0.04-0.85). No participants died during the study.

The article notes that, in the RECOVERY trial, dexamethasone resulted in a lower 28-day mortality among patients with severe COVID-19, adding, "Inhaled corticosteroids may also be beneficial in COVID-19 treatment, as they reduce the expression of key proteins that are involved in the entry of the virus into host cells. "Inhaled corticosteroids have also been shown to cause downregulation of COVID-19 genes."

Researchers point out that among the available inhaled corticosteroids, ciclesonide has been considered as a potential treatment option for COVID-19. In vitro, the drug has been shown to have antiviral properties against COVID-19 and blocks COVID-19 viral replication. In addition, a case series described three elderly patients with COVID-19 hypoxia who recovered following treatment with ciclesonide.

"Clinical trials are needed to determine the effects of ciclesonide on COVID-19 in the clinical setting. This study examined the effects of ciclesonide vs placebo in non-hospitalized participants with symptomatic COVID-19 infection," the authors write.

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