A multicenter, open-label, randomized controlled phase II study to evaluate the efficacy and safety of inhaled ciclesonide for asymptomatic and mild patients with COVID-19
- Conditions
- D000073640COVID-19
- Registration Number
- JPRN-jRCTs031190269
- Lead Sponsor
- Sugiyama Haruhito
- Brief Summary
We conducted a randomized clinical trial to determine the efficacy and safety of inhaled ciclesonide for COVID-19. In patients with mild COVID-19 disease, pneumonia on CT did not improve but rather worsened in the inhaled ciclesonide group compared to symptomatic treatment group. Safety was not different in the two groups, and there were no serious adverse events.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 90
1) Patient who have given written consent to participate in the study
2) Age is over 20 years old, regardless of gender.
3) SARS-CoV-2 PCR positive
4) Patients who have no apparent pneumonia due to COVID-19 on plain chest radiographs
5) Patients who can be hospitalized during study drug administration (Including accommodation and medical treatment)
6) Patients who can inhale ciclesonide using inhalation assist device
1) Patients with a history of hypersensitivity to Ciclesonide
2) Except for COVID-19, who have infectious disease or deep mycosis without an effective antibacterial agent
3) Patients using inhaled or oral steroids
4) Patients with fever of 37.5 degrees for 7 days
5) Patients co-administering treatments that may have therapeutic effects on COVID-19
6) Patients who are considered inappropriate for inclusion in the study by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method