COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCTs031210579

Naoto Yokogawa

yokogawan@aol.com

2022-01-24

Recruiting

RCT

Randomized

Parallel

Open label

unclear

Treatment

1) Positive SARS-CoV-2 test (confirmed by antigen test or nucleic acid detection test using samples collected within 2 weeks before eligibility evaluation)2) After 4 days from the onset ( If the onset date is unknown, the SARS-CoV-2 test date will be used. )3) High fever (38.0 degrees or higher) within 24 hours before inclusion (body temperature may be confirmed by the patient's fever record or accommodation facility record). 4) The age at the time of obtaining consent is 20 to 74 years old5) Those who understand the contents of the clinical trial and can obtain written consent to participate in the trial.

1) Those who require oxygen (room oxygen saturation of 93% or less )2) Those who do not agree to treatment in hospital3) Those who are taking colchicine4) Those who are taking 10 mg or more of prednisolone daily (or equivalent dose of other glucocorticoids)5) Use of glucocorticoids (orally or intravenously) within the past week.6) Sleep apnea syndrome or suspected sleep apnea syndrome7) Severe diarrhea8) Use of CYP3A4 inhibitor or P-glycoprotein inhibitor9) Liver dysfunction AST or ALT exceeds 5 times the upper limit of normal value10) Renal dysfunction eGFR less than 30mL / min / 1.73m211) Patients with a history of hypersensitivity to the ingredients of this drug12) Pregnant women or women who may be pregnant at the interview

4

Yokogawa Naoto

20

74

Japan

No restriction on type of patients

0: No restriction on type of patients

240

Use of oxygen (for 12 hours or longer) during admission or by Day 28

Phase 2

[{"arm_notes": "<70 years old and eGFR >= 60; 3 tablets a day", "treatment_id": 310, "treatment_name": "Colchicine", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "<70 years old and eGFR >= 60; 2 tablets a day", "treatment_id": 310, "treatment_name": "Colchicine", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": ">=70 years old or eGFR of <60; 2 tablets a day", "treatment_id": 310, "treatment_name": "Colchicine", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": ">=70 years old or eGFR of <60; 1 tablets a day", "treatment_id": 310, "treatment_name": "Colchicine", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}]