Inhaled ciclesonide no better than placebo for reducing COVID-19 symptoms: JAMA
USA: Results from a randomized clinical trial showed that Alvesco (ciclesonide, Covis Pharma) did not achieve the primary efficacy endpoint of a reduced time to alleviation of all COVID-19–related symptoms.
Brian M. Clemency and the team in their research, published in JAMA Internal Medicine suggest the need for future studies of inhaled steroids 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.
Systemic corticosteroids are used commonly for the treatment of severe COVID-19. However, the role of inhaled corticosteroids in treating patients with mild to moderate disease is ambiguous. To clarify the same Clemency with the colleagues set out 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.
For this purpose, the researchers conducted a phase 3, multicenter, double-blind, randomized clinical trial at 10 centers throughout the US. They assessed the safety and efficacy of a ciclesonide metered-dose inhaler (MDI) for treating nonhospitalized participants with symptomatic COVID-19 infection who were screened from June 11, 2020, to November 3, 2020.
400 participants were randomly assigned to receive ciclesonide MDI, 160 μg per actuation, for a total of 2 actuations twice a day (total daily dose, 640 μg; n=197) or placebo (n=203) for 30 days.
Following were the study's key findings:
- The median time to alleviation of all COVID-19–related symptoms was 19.0 days in the ciclesonide arm and 19.0 days in the placebo arm.
- There was no difference in resolution of all symptoms by day 30 (odds ratio, 1.28).
- 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).
- No participants died during the study.
"The results of this randomized clinical trial demonstrated that ciclesonide did not achieve the primary efficacy end point of reduced time to alleviation of all COVID-19–related symptoms.
These composite efficacy outcomes were based on resolution of all COVID-19 symptoms.
Clemency BM, Varughese R, Gonzalez-Rojas Y, et al. Efficacy of Inhaled Ciclesonide for Outpatient Treatment of Adolescents and Adults With Symptomatic COVID-19: A Randomized Clinical Trial. JAMA Intern Med. Published online November 22, 2021. doi:10.1001/jamainternmed.2021.6759