Open Label Randomized Clinical Trial BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from baseline in clinical assessment score COVID 19 (CAS COVID 19)
研究概览
简要总结
Patients with mild and severe COVID 19 will be randomized 1:1 into two groups: experimental, which will get bromhexine and spironolactone, and control. Patients will get investigated therapy for ten days. Change in clinical assessment score COVID 19 (CAS COVID 19) between baseline and 12th day will be evaluated as a primary endpoint. Forty-five-day risk of death or mechanical ventilation 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
- Single (Outcomes Assessor)
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 Spironolactone
- •hypersensitivity to Bromhexine
- •Known liver failure
- •Glomerular filtration rate <20 ml/ min
- •physician judgment that the patient will need mechanical ventilation in 24 hours
- •other indications for Spironolactone
- •Active cancer
研究组 & 干预措施
Bromhexine And Spironolactone
干预措施: Bromhexine and Spironolactone (Drug)
Base therapy
干预措施: Base therapy (Drug)
结局指标
主要结局
Change from baseline in clinical assessment score COVID 19 (CAS COVID 19)
时间窗: baseline, day 12
change in CAS COVID 19 between baseline and 12th +/- 2 days CAS COVID 19 measures clinical and laboratory parameters in 7 domains: respiratory rate (\< 18 - 0 point; 18-22 - 1 point; 23-26 - 2 point; \>26 - 3 point) body temperature (35.5 - 37.0 - 0 point; \< 35.5 - 1 point; 37.1 - 38.5 - 1 point; \> 38.5 - 2 point) Sp02 without support oxygen (\> 93% - 0 point; 90-93% - 1 point; \< 90% - 2 point) ventilation (not required - 0 point; low-flow ventilation - 1 point; Non-invasive positive pressure ventilation - 2 point; mechanical ventilation - 3 point) C-reactive protein (\> 10 - 0 point; 10-59 - 1 point; 60-120 - 2 point; \> 120 - 3 point) d - dimer (\< 0.51 - 0 point; 0.51 - 2.0 - 1 point; 2.01 - 5.0 - 2, \> 5.0 - 3 point) 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
- - Combine endpoint -(12 days, 45 days)
- Hospital length of stay(up to 45 days)
- C-reactive protein(12 days, 45 days)
- EuroQol Group. EQ-5D™(12 days, 45 days)
- HADS(14 days, 45 days)
- EuroQol Group. EQ VAS(12 days, 45 days)
- D-dimer(12 days, 45 days)