JPRN-jRCTs031210579招募中2 期
Colchicine for preventing respiratory failure in COVID-19 with fever: a randomized controlled trial - COLPREF
Yokogawa Naoto0 个研究点目标入组 240 人开始时间: 2022年1月24日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 84age old（—）
- 性别
- All
入选标准
- •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 18 to 84 years old
- •5) Those who understand the contents of the clinical trial and can obtain written consent to participate in the trial.
排除标准
- •1) Those who require oxygen (room oxygen saturation of 93% or less )
- •2) Those who do not agree to treatment in hospital
- •3) Those who are taking colchicine
- •4) 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 syndrome
- •7) Severe diarrhea
- •8) Use of CYP3A4 inhibitor or P-glycoprotein inhibitor
- •9) Liver dysfunction AST or ALT exceeds 5 times the upper limit of normal value
- •10) Renal dysfunction eGFR less than 30mL / min / 1.73m2
- •11) Patients with a history of hypersensitivity to the ingredients of this drug
- •12) Pregnant women or women who may be pregnant at the interview
研究者
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