The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Clinical deterioration in the semiquantitative ordinal scale suggested by the WHO R&D committee
研究概览
简要总结
Based on data regarding the effect of colchicine on the inflammasome NLP3 and microtubule formation and associations thereof with the pathogenetic cycle of SARS-COV-2, the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect the patients' clinical course by limiting the myocardial necrosis and pneumonia development in the context of COVID-19. If present, this effect would be attributed to its potential to inhibit inflammasome and (less probably) to the process of SARS-CoV-2 endocytosis in myocardial and endothelial respiratory cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >18 years old with laboratory confirmed SARS-CoV-2 infection (RT PCR) AND body temperature >37.5 degrees centigrade AND at least two of: i. sustained coughing, ii. sustained throat pain, iii. anosmia and/or ageusia, iv. fatigue/tiredness, v. PaO2<95 mmHg.
排除标准
- •pregnancy, lactation;
- •known hypersensitivity to colchicine
- •known hepatic failure
- •eGFR<20 ml/min
- •clinical estimation that the patient will require mechanical respiratory support in less than 24 hours
- •any clinical estimation of the attending physician under which the patient shall be excluded
- •QTc > 450 msec (colchicine is not known to significantly prolong QTc, but may interact with other medications which prolong QTc).
- •participation in another clinical trial
- •under colchicine treatment for other indications
- •patient who is not likely to comply to study procedures
研究组 & 干预措施
Intervention
Colchicine, on top of standard treatment
干预措施: Colchicine (Drug)
Intervention
Colchicine, on top of standard treatment
干预措施: Standard treatment (Drug)
Control
Standard treatment, including all medications recommedned by the National Public Health Organization
干预措施: Standard treatment (Drug)
结局指标
主要结局
Clinical deterioration in the semiquantitative ordinal scale suggested by the WHO R&D committee
时间窗: 3 weeks
Time to clinical deterioration (2 levels in the WHO R\&D Blueprint scale)
Maximal concentration of cardiac troponin
时间窗: 10 days
Maximal concentration of high-sensitivity cardiac troponin
次要结局
未报告次要终点
研究者
Spyridon Deftereos
Professor of Cardiology
National and Kapodistrian University of Athens