EUCTR2020-001455-40-GR进行中（未招募）1 期
The Greek study in the Effects of Colchicine in Covid-19 complications prevention - GRECCO-19
Hellenic Society of Rhythmology0 个研究点目标入组 180 人开始时间: 2020年4月1日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients >18 years old with laboratory confirmed SARS-CoV-2 infection (under RT PCR) and clinical status that involves body temperature >37.5 oC
- •2. at least two out of the:
- •i. sustained coughing,
- •ii. sustained throat pain,
- •iii. anosmia and/or ageusia,
- •iv. fatigue/tiredness,
- •v. PaO2<95 mmHg.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 126
排除标准
- •1. Pregnancy, breastfeeding, or unwillingness to take effective contraceptive methods in men and women of reproductive ability during the clinical trial
- •2. Hypersensitivity in Colchicine or in any of the excipients of the product (lactose, gum arabic, sucrose, magnesium stearate, microcrystalline cellulose, polyvinylpyrrolidone, methylene casein, erythrosine lacquer).
- •3. Serious hepatic failure
- •4. eGFR<20 ml/min/1.73m2
- •5. Clinical estimation that the patient will require mechanical respiratory support in less than 24 hours.
- •6. Any clinical estimation of the attending physician under which the patient shall be excluded
- •7. QTc > 450 msec.
- •8. Participation in a clinical trial with a research product (medication or device) or intervention.
- •9. Being treated with colchicine for other indications.
- •10. A person who, at the discretion of the Researcher, is unable to comply with or participate in the clinical trial may place it at unacceptable health risks.
- •11. A person undergoing haemodialysis
- •12. Severe gastrointestinal failure, severe gastrointestinal disorder, or stomach ulcer
- •13. Hematological disorders, such as blood disease
- •14. Under treatment or 14 days after use of P-glycoprotein inhibitors or CYP3A4 enzyme inhibitors
研究者
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