Efficacy and Safety of Escin as add-on Treatment in Covid-19 Infected Patients
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mortality rate
研究概览
简要总结
In December 2019,a new type of pneumonia caused by the coronavirus (COVID-2019) broke out in Wuhan ,China, and spreads quickly to other Chinese cities and 28 countries. More than 70000 people were infected and over 2000 people died all over the world. There is no specific drug treatment for this disease. Considering that lung damage is related to both viral infection and burst of cytokines, our idea is to evaluate the efficacy and safety of escin as add-on treatment to conventional antiviral drugs in COVID-19 infected patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 75 years, extremes included, male or female
- •Positivity to covid-19 screening test in molecular biology
- •In escin group: Low response to standard treatment
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Female subjects who are pregnant or breastfeeding.
- •patients with previous history to allergy
- •patients meet the contraindications of escin
- •Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.
- •patients can't take drugs orally
研究组 & 干预措施
oral escin group
Standard therapy+Escin tablet 40mg*3, os for 12 days
干预措施: Escin (Drug)
oral escin group
Standard therapy+Escin tablet 40mg*3, os for 12 days
干预措施: standard therapy (Drug)
control group
standard therapy
干预措施: standard therapy (Drug)
parenteral escin group
standard treatment + sodium Escinate 20mg iv/day for 12 days
干预措施: Escin (Drug)
parenteral escin group
standard treatment + sodium Escinate 20mg iv/day for 12 days
干预措施: standard therapy (Drug)
结局指标
主要结局
Mortality rate
时间窗: up to 30 days
All cause mortality
Clinical status evaluated in agreement with guidelines
时间窗: up to 30 days
mild type：no No symptoms, Radiological examination: no pneumonia; possible mild increase in C-reactive portein 2, moderate type: fever, cough, or other respiratory symptoms. Radiological examination: pneumonia, SpO2\>93% without oxygen inhalation ; increase in C reactive protein, 3: severe type: a. Rate ≥30bpm；b. Pulse Oxygen Saturation (SpO2)≤93% without oxygen inhalation，c. PaO2/FiO2(fraction of inspired oxygen )≤300mmHg ；4. Critically type：match any of the follow: a. need mechanical ventilation; b. shock; c. (multiple organ dysfunction syndrome) MODS
次要结局
- The differences in oxygen intake methods(up to 30 days)
- Time of hospitalization (days)(up to 30 days)
- Time of hospitalization in intensive care units(up to 30 days)
- Pulmonary function(up to 3 months after discharge)
研究者
Luca Gallelli
Clinical Professor
University of Catanzaro