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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

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 - RACCO trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031190269
Enrollment
90
Registered
2020-03-27
Start date
2020-04-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 COVID-19

Interventions

Ciclesonide is inhaled three times a day at a dose of 400 microgram once a day for seven consecutive days.

Sponsors

Sugiyama Haruhito
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Pneumonia incidence on day 8 of ciclesonide inhalation

Secondary

MeasureTime frame
1) Changes in clinical findings 2) Changes in laboratory findings 3) SARS CoV 2 virus genome amount 4) Incidence rates of adverse events

Contacts

Public ContactTerada Junko

Center Hospital of the National Center for Global Health and Medicine

jterada@hosp.ncgm.go.jp+81-3-3202-7181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026