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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
(RACCO trial)

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)

90

The number of patients included in the study was 90 (41 in the ciclesonide group and 49 in the symptomatic treatment group). One patient in the symptomatic treatment group was excluded from the FAS because baseline (Day 1) CT imaging data were not available. The backgrounds of the 41 patients in the ciclesonide group and the 48 patients in the symptomatic treatment group were as follows Gender (female) 51.2%, 50.0 Age 38.7 years, 42.7 years BMI 22.53, 23.74

Case enrollment began on April 3, 2020. Ninety patients who met the inclusion criteria for the clinical study were eligible for randomized grouping, 41 in the ciclesonide group and 49 in the symptomatic treatment group. One patient in the symptomatic treatment group was excluded from the FAS because baseline (Day 1) CT imaging data were not available.

Three cases of illness occurred in the ciclesonide group (1 chest discomfort, 1 developmental disorder, and 1 oropharyngeal pain) and 1 case in the symptomatic treatment group (1 increased creatine phosphokinase in blood). All were mild and the outcome was recovery.

The primary endpoint, the rate of pneumonia exacerbations within 7 days of ciclesonide inhalation, was 39.0% (16/41) in the ciclesonide group and 18.8% (9/48) in the symptomatic treatment group, with a risk difference of 0.20 (90% confidence interval 0.05-0.36). The main secondary endpoint, the change in the log of viral load on nasopharyngeal swabs from day 0 to day 8, was not significantly different between the two groups. Safety did not differ between the two groups, and there were no serious adverse events.

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.

May. 01, 2022

Yes

The data obtained in this study will be registered in the Registry Study on COVID-19 (NCGM Ethics Review Committee Approval Number: NCGM-G-003494-00) after completion of the study report (publication).

https://jrct.niph.go.jp/latest-detail/jRCTs031190269

Sugiyama Haruhito

Center Hospital of the National Center for Global Health and Medicine

1-21-1, Toyama, Shinjuku-ku, Tokyo

hasugiya@hosp.ncgm.go.jp

Junko Terada

Center Hospital of the National Center for Global Health and Medicine

1-21-1, Toyama, Shinjuku-ku, Tokyo

+81-3-3202-7181

jterada@hosp.ncgm.go.jp

Complete

Mar. 27, 2020

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

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

Both

COVID-19

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

COVID-19

D000073640

Pneumonia incidence on day 8 of ciclesonide inhalation

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

+81-3-5841-0818

Mar. 24, 2020

none