NCT05151614已完成1 期
Adjuvant Use Of Colchicine With The Standard Therapy In Moderate And Severe Corona Virus Disease-19 Infection: Randomized Controlled Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- - To assess the percentage of cure of the patients
研究概览
简要总结
The study included 2 arms Colchicine group: Colchicine + standard therapy of COVID-19 Control group: Standard therapy of COVID-19
详细描述
This study will be a randomized controlled trial with 2 arms study trial 1:1 allocation. The sample size was calculated and we need a total of 160 patients (80 Colchicine add on group and 80 controls)
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 with age above 18 years and of any gender
- •Definite diagnosis of COVID-19 according to the WHO classification criteria
- •Patients symptomatic for no more than three days for mild-moderate cases, no more than two days after being severe cases
- •Understands and agrees to comply with planned study procedures.
排除标准
- •Patients refuse to enrol in the study
- •Patients with hypersensitivity to colchicine
- •Patients with chronic diseases: Renal failure with eGFR<30 ml/min; chronic liver disease with hepatic failure (AST/ALT > 3x normal).; decompensated heart failure, long QT syndrome (QTc >450 msec.), and uncontrolled arrhythmia; inflammatory bowel disease, chronic diarrhea or malabsorption; pre-existent progressive neuromuscular disease, and Metastatic cancer
- •Pregnancy and breast feeding
- •Medications: immunosuppressive chemotherapy; regular use of digoxin, amiodarone, verapamil or protease inhibitors.
研究组 & 干预措施
Colchicine group
Experimental
Colchicine 0.5 mg tab 1x2 for 1 week then o.5mg tab. 1x1 for another week + the standard therapy
干预措施: Colchicine 0.5 MG (Drug)
结局指标
主要结局
- To assess the percentage of cure of the patients
时间窗: up to 14 days
evauated by normalization of clinical evaluation, laboratory investigations, and imaging
- Study the time to recovery
时间窗: up to 14 days
Evaluated by stay days in hospital
次要结局
- - to assess side effects seen during the trial(up to 14 days)
研究者
Faiq Gorial
Professor
University of Baghdad
研究点 (1)
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