Effects of Standard Protocol Therapy With or Without Colchicine in Covid-19 Infection: A Randomized Double Blind Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- PCR Viral Load
研究概览
简要总结
Based on data regarding the effect of colchicine on the modulation of immune system and decreasing cytokine release and inflammation the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect on COVID-19 Polymerase chain reaction(PCR) positive patients .
详细描述
80 Patients with positive nasopharyngeal swab PCR for COVID-19 which were not hypoxic but showed computed tomography involvement compatible with COVID-19 admitted in ward (not in Intensive care unit) included and randomized in to two groups. All patients received standard treatment protocol including essential minerals, vitamins as antioxidants, antibiotics and Kaletra while in one randomly assigned group colchicine would be added.
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
- Double (Participant, Investigator)
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 nasopharyngeal swab confirmed COVID-19 PCR, CT involvement compatible with COVID, Fever and Dyspnea without hypoxemia.
排除标准
- •Patient who is not willing to enter in study
- •Known hypersensitivity to colchicine
- •Hepatic failure
- •Renal failure with eGFR<20 ml/min
研究组 & 干预措施
Intervention
40 RT-PCR positive COVID-19 patients without hypoxemia administered Colchicine plus standard treatment
干预措施: Colchicine Tablets (Drug)
结局指标
主要结局
PCR Viral Load
时间窗: 2 weeks
change in RT-PCR
Clinical deterioration by the WHO definition
时间窗: 2 weeks
including change in fever or O2 Saturation
CRPxN/R ratio change
时间窗: 2 weeks
increasing inflammatory status
CT severity involvement index
时间窗: 2weeks
change in CT involvement
次要结局
- LDH change(2 weeks)
研究者
nooshin dalili
Principal Investigator
Shahid Beheshti University of Medical Sciences