COLchicine Versus Ruxolitinib and Secukinumab in Open-label Prospective Randomized Trial in Patients With COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- change from baseline in clinical assessment score COVID 19 (CAS COVID 19) Frame: baseline
研究概览
简要总结
Patients with mild and severe coronavirus disease 2019 (COVID 19) will be randomized 3:1:1:3 into four groups: colchicine, ruxolitinib, secukinumab, and control groups. . Patients will be follow-up during 45 days after randomization. Change in clinical assessment score COVID 19 (CAS COVID 19) between baseline and 12th day will be evaluated as the primary endpoint. Risk of death or mechanical ventilation during 45 days after randomization will also be assessed
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
- •Signed inform consent
- •COVID 19 with the mild and severe course. The diagnosis could be made with positive polymerase chain reaction (PCR) (International Statistical Classification (ICD-10) code - U07.1) and/or virus pneumonia in computer tomography (ICD 10 code - U07.2)
- •Lung exposure on CT more than 25%
- •Sp02 without supportive oxygen ≤ 93%
- •C-reactive protein > 60 mg/l or elevation of C reactive protein 3 times in 8-14 days after first symptoms
排除标准
- •pregnancy and breastfeeding
- •hypersensitivity to colchicine
- •hypersensitivity to ruxolitinib
- •hypersensitivity to secukinumab
- •Known liver failure
- •Glomerular filtration rate <20 ml/ min
- •physician judgment that the patient will need mechanical ventilation in 24 hours
- •QTc > 450 ms
- •other indications for to colchicine, ruxolitinib, and secukinumab
- •Chronic therapy with corticosteroids or immunosuppressive therapy
- •Active cancer
研究组 & 干预措施
4.Standard treatment
-30 patients Patients with mild and severe COVID 19 Patients will get investigated therapy for ten days. Patients will be follow-up during 45 days after randomization
干预措施: standard therapy (Other)
1. Colchicine
30 Patients with mild and severe COVID 19 Patients will get investigated therapy for ten days. Patients will be follow-up during 45 days after randomization
干预措施: Colchicine (Drug)
2. Ruxolitinib
10 Patients with mild and severe COVID 19 Patients will get investigated therapy for ten days. Patients will be follow-up during 45 days after randomization
干预措施: Ruxolitinib 5 MG (Drug)
3.Secukinumab
10 Patients with mild and severe COVID 19 Patients will get investigated therapy singly. Patients will be follow-up during 45 days after randomization
干预措施: Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX] (Drug)
结局指标
主要结局
change from baseline in clinical assessment score COVID 19 (CAS COVID 19) Frame: baseline
时间窗: baseline, day 12
CAS COVID 19 measures clinical and laboratory parameters in 7 domains: 1. respiratory rate (\< 18 - 0 point; 18-22 - 1 point; 23-26 - 2 point; \>26 - 3 point) 2. body temperature (35.5 - 37.0 - 0 point; \< 35.5 - 1 point; 37.1 - 38.5 - 1 point; \> 38.5 - 2 point) 3. Sp02 without support oxygen (\> 93% - 0 point; 90-93% - 1 point; \< 90% - 2 point) 4. ventilation (not required - 0 point; low-flow ventilation - 1 point; Non-invasive positive pressure ventilation - 2 point; mechanical ventilation - 3 point) 5. C-reactive protein (\> 10 - 0 point; 10-59 - 1 point; 60-120 - 2 point; \> 120 - 3 point) 6. d - dimer (\< 0.51 - 0 point; 0.51 - 2.0 - 1 point; 2.01 - 5.0 - 2, \> 5.0 - 3 point) 7. exposure area on lung CT (no pneumonia - 0; 1-24% - 1 point; 25-50% - 2; 51-75% - 3, \> 75% - 4). Minimal number of points - 0; max - 20. Lower the score-better health
次要结局
- D-dimer(baseline, day 12, day 45)
- EuroQol Group. EQ-5D™(baseline, day 12, day 45)
- Combine endpoint: Time to death or mechanical ventilation(45 days)
- C-reactive protein(baseline, day 12, day 45)
- exposure area on lung CT(baseline, day 12, day 45)