Drug Discov Ther. 2022;16(5):225-232. (DOI: 10.5582/ddt.2022.01068)

Impact of inhaled ciclesonide on asymptomatic or mild COVID-19: A randomized trial

Terada-Hirashima J, Suzuki M, Tsujimoto Y, Hamamoto Y, Uemura Y, Tsushima K, Inoue H, Komatsu S, Saito Z, Tsuzuki R, Okamoto M, To Y, Moriya K, Yoshizawa S, Tanaka M, Muto T, Mikami A, Takasaki J, Izumi S, Ohmagari N, Hojo M, Sugiura W, Sugiyama H

The aim of this study was to determine the efficacy and safety of ciclesonide in the treatment of novel coronavirus disease 2019 (COVID-19) as gauged by pneumonia progression. This multi-center, open-label randomized trial was conducted with patients recruited from 22 hospitals across Japan. Participants were patients admitted with mild or asymptomatic COVID-19 without signs of pneumonia on chest X-rays. Asymptomatic participants were diagnosed after identification through contact tracing. Trial participants were randomized to either the ciclesonide or control arm. Participants in the treatment arm were administered 400 μg of ciclesonide three times a day over seven consecutive days. The primary endpoint was exacerbated pneumonia within seven days. Secondary outcomes were changes in clinical findings, laboratory findings, and changes over time in the amount of the viral genome. In the treatment group, 16 patients (39.0%) were classified as having exacerbated pneumonia compared to 9 (18.8%) in the control group. The risk ratio (RR) was 2.08 (95% confidence interval (CI): 1.15-3.75), indicating a worsening of pneumonia in the ciclesonide group. Significant differences were noted in participants with a fever on admission (RR: 2.62, 90% CI: 1.17-5.85, 95% CI: 1.00-6.82) and individuals 60 years of age or older (RR: 8.80, 90% CI: 1.76-44.06, 95% CI: 1.29-59.99). The current results indicated that ciclesonide exacerbates signs of pneumonia on images in individuals with mild or asymptomatic symptoms of COVID-19 without worsening clinical symptoms.

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