跳至主要内容
临床试验/NCT05269511
NCT05269511已完成不适用

Efficacy of Chinese Herbal Medicine to Prevent and Treat COVID-19 Close Contacts: A Randomized Controlled Trial

Hong Kong Baptist University1 个研究点 分布在 1 个国家目标入组 2,163 人开始时间: 2022年3月14日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

ZhaoXiang Bian

Professor

Hong Kong Baptist University

研究点 (1)

Loading locations...

相似试验