Efficacy of Chinese Herbal Medicine to Prevent and Treat COVID-19 Close Contacts: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hong Kong Baptist University
- Enrollment
- 2,163
- Locations
- 1
- Primary Endpoint
- Proportion of subjects who have PCR confirmed SARS-CoV-2 infection
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Treatment group
Chinese Herbal Medicine
Intervention: Chinese herbal medicine is in the form of granules (9 g/sachet), which is comprised of ten medicinal herbs. (Drug)
Outcomes
Primary Outcomes
Proportion of subjects who have PCR confirmed SARS-CoV-2 infection
Time Frame: 3 weeks
Proportion of subjects who subsequently develop COVID-19 symptoms or signs
Time Frame: 3 weeks
Proportion of subjects with treatment-emergent adverse events (TEAEs) and severity of TEAEs
Time Frame: 3 weeks
Proportion of subjects who subsequently develop moderate to severe COVID-19 infection
Time Frame: 3 weeks
Secondary Outcomes
- 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)
Investigators
ZhaoXiang Bian
Professor
Hong Kong Baptist University