Efficacy of Chinese Herbal Medicine to Prevent and Treat COVID-19 Close Contacts: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,163
- 试验地点
- 1
- 主要终点
- Proportion of subjects who have PCR confirmed SARS-CoV-2 infection
研究概览
简要总结
This is a randomized, blank-controlled study in adults with household contact exposure to individuals with SARS-CoV-2 infection. All subjects in the study will be household contacts with close exposure to the first household member known to be newly infected with SARS-CoV-2. Subjects in each cohort will be randomly assigned to the Chinese herbal medicine treatment group or blank control group in a 4:1 ratio, followed by 1 week of the treatment period and 2 weeks of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Household contact exposure to individuals with SARS-CoV-2 infection
- •General healthy or have a chronic, stable medical condition
- •Voluntarily signing a written informed consent form
- •Able to follow written and oral instructions in Chinese
排除标准
- •Moderate to severe symptomatic SARS-CoV-2 infection
- •An allergic history to Chinese herbal drugs or a known allergy to the ingredients of the study drug
- •Pregnancy, breastfeeding or plan to become pregnant within the study timeframe
- •Vulnerable adults (i.e., mentally or physically disabled to take care of himself/herself)
- •Any physical examination findings, and/or history of any illness, or concomitant medications that, in the opinion of the study investigator, might not be suitable to participate in the study
研究组 & 干预措施
Treatment group
Chinese Herbal Medicine
干预措施: Chinese herbal medicine is in the form of granules (9 g/sachet), which is comprised of ten medicinal herbs. (Drug)
结局指标
主要结局
Proportion of subjects who have PCR confirmed SARS-CoV-2 infection
时间窗: 3 weeks
Proportion of subjects who subsequently develop COVID-19 symptoms or signs
时间窗: 3 weeks
Proportion of subjects with treatment-emergent adverse events (TEAEs) and severity of TEAEs
时间窗: 3 weeks
Proportion of subjects who subsequently develop moderate to severe COVID-19 infection
时间窗: 3 weeks
次要结局
- Number of days of PCR confirmed SARS-CoV-2 infection(3 weeks)
- Number of days of symptomatic PCR confirmed SARS-CoV-2 infection(3 weeks)
研究者
ZhaoXiang Bian
Professor
Hong Kong Baptist University