6/28/23, 12:26 AM Ciclesonide-COVID Pathway Feedback Search Clinical Topics Home Studies Ciclesonide-COVID Ciclesonide-COVID Disease COVID 19 infection Trial question What is the effect of inhaled ciclesonide in nonhospitalized participants with symptomatic COVID-19 infection? Study design Multi-center Double blinded RCT Population Characteristics of study participants 55.0% female N = 400 45.0% male 400 patients (221 female, 179 male) Inclusion criteria: nonhospitalized participants with symptomatic COVID-19 infection Key exclusion criteria: life-threatening co-morbidity; cystic fibrosis; hypersensitivity to ciclesonide; use of inhaled or intranasal corticosteroid; receipt of oral corticosteroids; receipt of hydroxychloroquine or chloroquine Interventions N=197 ciclesonide metered dose inhaler (160 g per actuation, 2 actuations BID for 30 days) N=203 placebo metered dose inhaler (matching placebo inhaler, 2 actuations BID for 30 days) Primary outcome Time to alleviate all COVID-19 related symptoms by day 30 19.0 days 19 19 14 3 days https://web.pathway.md/studies/recD56IcE1fHDN7OF 1/2 6/28/23, 12:26 AM 14.3 days Ciclesonide-COVID Pathway 9.5 days 4.8 days No significant difference 0.0 days Ciclesonide metered dose inhaler Placebo metered dose inhaler No significant difference in time to alleviate all COVID-19 related symptoms by day 30 (19 days vs. 19 days; HR 1.08, 95% CI 0.84 to 1.38) Secondary outcomes Significant decrease in the rate of COVID-19 related emergency department visits or hospital admissions by day 30 (1% vs. 5.4%; OR 0.18, 95% CI 0.04 to 0.85) No significant difference in the rate of hospital admission or death by day 30 (1.5% vs. 3.4%; OR 0.45, 95% CI 0.11 to 1.84) No significant difference in COVID-19 symptoms reduction by day 30 (70.6% vs. 63.5%; OR 1.28, 95% CI 0.84 to 1.97) Safety outcomes No significant difference in adverse events. Conclusion In nonhospitalized participants with symptomatic COVID-19 infection, ciclesonide metered dose inhaler was not superior to placebo metered dose inhaler with respect to time to alleviate all COVID-19 related symptoms by day 30. Reference Brian M Clemency, Renoj Varughese, Yaneicy Gonzalez-Rojas et al. Efficacy of Inhaled Ciclesonide for Outpatient Treatment of Adolescents and Adults With Symptomatic COVID-19: A Randomized Clinical Trial. JAMA Intern Med. 2022 Jan 1;182(1):42-49. Open reference URL https://web.pathway.md/studies/recD56IcE1fHDN7OF 2/2