JRCTS031190269.

Study name	A multicenter, open‐label, randomised controlled phase II study to evaluate the efficacy and safety of inhaled ciclesonide for asymptomatic and mild patients with COVID‐19 (RACCO trial)
Methods	Trial design: randomised, open‐label Sample size: 90 Setting: outpatient Language: English/Japanese Number of centres: "multicentre" Type of intervention: treatment
Participants	Inclusion criteria: given written consent to participate in the study age > 20 years, regardless of sex SARS‐CoV‐2 PCR positive no apparent pneumonia due to COVID‐19 on plain chest radiographs who can be hospitalised during study drug administration (including accommodation and medical treatment) can inhale ciclesonide using inhalation assist device Exclusion criteria: history of hypersensitivity to ciclesonide except for COVID‐19, who have infectious disease or deep mycosis without an effective antibacterial agent using inhaled or oral steroids with fever of 37.5 °C for 7 days co‐administering treatments that may have therapeutic effects on COVID‐19 considered inappropriate for inclusion in the study by the investigator
Interventions	Intervention group: inhaled ciclesonide 400 µg 3 times per day Control group: not reported Concomitant therapy: not reported
Outcomes	Primary outcome: pneumonia incidence on day 8 of ciclesonide inhalation Secondary outcomes: changes in clinical findings; changes in laboratory findings; SARS‐CoV‐2 virus genome amount; incidence rates of adverse events
Starting date	3 April 2020
Contact information	Sugiyama Haruhito: hasugiya@hosp.ncgm.go.jp
Notes	Recruitment status: "not recruiting" Prospective completion date: not reported Date last update was posted: 24 September 2020 Sponsor/funding: not reported