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Course: Efficacy of Inhaled Ciclesonide for Outpatient Treatment of Adolescents and Adults With Symptomatic COVID-19: A Randomized Clinical Trial

CME Credits: 1.00

Released: 2021-11-22

Key Points

Question Can the inhaled steroid ciclesonide reduce the time to alleviation of all COVID-19–related symptoms among nonhospitalized participants with symptomatic COVID-19 infection?
Findings In this randomized clinical trial of 400 patients with symptomatic COVID-19, ciclesonide did not reduce the time to alleviation of all COVID-19–related symptoms. However, patients who were treated with ciclesonide had fewer subsequent emergency department visits or hospital admissions for reasons that were related to COVID-19.
Meaning The results of this 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 postacute sequelae of SARS-CoV-2.

Abstract

Importance Systemic corticosteroids are commonly used in treating severe COVID-19. However, the role of inhaled corticosteroids in the treatment of patients with mild to moderate disease is less clear.
Objective 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.
Design, Setting, and Participants This phase 3, multicenter, double-blind, randomized clinical trial was conducted at 10 centers throughout the US and 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.
Interventions Participants were randomly assigned to receive ciclesonide MDI, 160 ?g per actuation, for a total of 2 actuations twice a day (total daily dose, 640 ?g) or placebo for 30 days.
Main Outcomes and Measures The primary end point was time to alleviation of all COVID-19–related symptoms (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 end points included subsequent emergency department visits or hospital admissions for reasons attributable to COVID-19.
Results A total of 413 participants were screened and 400 (96.9%) were enrolled and randomized (197 [49.3%] in the ciclesonide arm and 203 [50.7%] in the placebo arm; mean [SD] age, 43.3 [16.9] years; 221 [55.3%] female; 2 [0.5%] Asian, 47 [11.8%] Black or African American, 3 [0.8%] Native Hawaiian or other Pacific Islander, 345 [86.3%] White, and 1 multiracial individuals [0.3%]; 172 Hispanic or Latino individuals [43.0%]). 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. There was no difference in resolution of all symptoms by day 30 (odds ratio, 1.28; 95% CI, 0.84-1.97). 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.
Conclusions and Relevance 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.
Trial Registration ClinicalTrials.gov Identifier:


Educational Objective
To identify the key insights or developments described in this article


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