Treatment of Non-severe SARS-CoV-2 Outpatients With Herbal Compound Xagrotin, Phase 3
试验速览
- 阶段
- 3 期
- 发起方
- Biomad AS
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
This is an interventional, multi-center, randomized study. Adults with confirmed covid-19 disease not more than 10 days before enrollment date will be recruited (n=1000). Patients in same condition who get treated with standard of care will be randomly assigned to the control group (n=1000), and patients in same condition who get treated with standard of care will be randomly assigned to the placebo group (n=1000). The investigators analyze the effect of Xagrotin, and also investigate impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome.
详细描述
An interventional, multi-center, randomized study that will performe in an outpatient setting (n=1000). Adults with confirmed covid-19 disease not more than 10 days before enrollment date will be recruited. Patients in same condition who had treated with standard of care will randomly assign to the control group (n=1000), and patients in same condition who get treated with standard of care will be randomly assigned to the placebo group (n=1000). The investigators analyze the effect of Xagrotin, and also investigate impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome. Adverse events will be registered.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or higher
- •Newly diagnosed (no longer than 10 days)
- •PCR or clinically confirmed Covid-19
排除标准
- •Coronavirus patients admitted to medical centers for hospitalization and receive medical treatment and necessary care in medical centers
研究组 & 干预措施
Treatment group
Patients in the Treatment arm receive Xagrotin extract 2 grams three times a day in combination to the standard of care for sars-cov-2.
干预措施: Xagrotin (Drug)
Placebo group
Patients in the Treatment arm receive green tea 2 grams three times a day in combination to the standard of care for sars-cov-2.
干预措施: Green tea (Drug)
结局指标
主要结局
Mortality
时间窗: 30 days
Number of Participants who die by day 30 after the enrollment
次要结局
- Duration of Disease From Beginning of Treatment(30 days)
- Hospitalization(30 days)
- Duration of Hospitalization When Occurred(30 days)