Treatment of Early-Stage Covid-19 With a Herbal Compound, Xagrotin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biomad AS
- 入组人数
- 661
- 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 were recruited (n=361). Patients in same condition who had treated with standard of care were randomly assigned to the control group (n=178). The investigators analyzed the effect of a herbal compound, Xagrotin, and also investigated impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome.
详细描述
This is an interventional, multi-center, randomized study that has been performed in an outpatient setting (n=361). Adults with confirmed covid-19 disease not more than 10 days before enrollment date were recruited. Patients in same condition who had treated with standard of care were randomly assigned to the control group (n=178). The investigators analyzed the effect of a herbal compound, Xagrotin, and also investigated impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome. Adverse events were 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 —（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
- •Severe pulmonary disease
- •Severe cardiovascular disease
- •Severe hepatic disease
- •Severe renal disease
- •Diabetes mellitus type one
- •Metabolic acidosis
- •Oxygen saturation <70%
- •Pregnancy
- •Breast feeding
- •Concomitant treatment with anticoagulation drugs
- •Concomitant treatment with CYP3A4 medicines with narrow therapeutic window
研究组 & 干预措施
Control arm
Patients in the Control arm received the standard of care for Covid19.
Treatment arm
Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19.
干预措施: Xagrotin (Combination Product)
结局指标
主要结局
Mortality
时间窗: 30 days
Number of Participants who died by day 30 after the enrollment
次要结局
- Duration of Disease From Beginning of Treatment(30 days)
- Duration of Hospitalization When Occurred(30 days)
- Hospitalization(30 days)