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

JRCT ID: jRCTs031190269

Registered date:27/03/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 03/04/2020
• Target sample size: 90
• Study type: Interventional
• Intervention(s): Ciclesonide is inhaled three times a day at a dose of 400 microgram once a day for seven consecutive days.

Outcome(s)

• Primary Outcome: Pneumonia incidence on day 8 of ciclesonide inhalation

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Sugiyama Haruhito
• Source(s) of Monetary Support: Health Labour Sciences Research Grant