COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCTs031200196

Jiro Terada

jirotera@iuhw.ac.jp

2020-11-11

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1) Patients who have given written consent to participate in the study2) age > 20 years old3) SARS-CoV-2 PCR or LAMP test positive or COVID-19 confirmed by the diagnostic test which is approved by the Ministry of Health, Labor and Welfare4) Patients with COVID-19 pneumonia on chest CT scan5) Patients who can admit on the hospital at least 10 days during treatment6) Patients who can use ciclesonide inhaler 7) Pregnancy test-negative

1) Patients who had been already treated with ceratain drug for COVID-192) Patients diagnosed with relapse or 2nd infection of COVID-193) Patiens with obvious other respiratory infection 4) Patients having cardiac dysfunctions such as congestive heart failure5) Patients having severe liver dysfunction such as Child-Pugh C state6) Patients having renal dysfunction requiring dialysis7) Patients having immuno deficiency such as HIV infection8) Patients having disorders of consciousness such as disorientation9) Patients using the drug of immuno suppression10) Patients using steroid inhaler11) Patients who are pregnant or who may be pregnant12) Patients who cannot use contraceptive 13) Male patients having a partner who agree with the usage of contraceptive 14) Patients with hereditary xanthineuria15) Patients with Patients with hypouricemia or xanthine urinary stone 16) Patients with retractable gout or hyperuricemia17) Patents with allergy of favipiravir, camostat mesilate or inhaled ciclesonide18) Patients in severe disease state with artificial ventilation, or ECMO in intensive care unit19) Patients who are considered inappropriate for inclusion in the study by the investigator

2

Tsushima Kenji

20

100

Japan

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

118

Length of hospital stay

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 1509, "treatment_name": "Camostat mesilate+ciclesonide+favipiravir", "treatment_type": "Antivirals+corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]