Healthy Participants
Conditions
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.
Interventions
DRUGChinese herbal medicine is in the form of granules (9 g/sachet), which is comprised of ten medicinal herbs.
Oral administration, twice per day.
Sponsors
Hong Kong Baptist University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Household contact exposure to individuals with SARS-CoV-2 infection 2. Aged ≥18 3. General healthy or have a chronic, stable medical condition 4. Voluntarily signing a written informed consent form 5. Able to follow written and oral instructions in Chinese
Exclusion criteria
1. Moderate to severe symptomatic SARS-CoV-2 infection 2. An allergic history to Chinese herbal drugs or a known allergy to the ingredients of the study drug 3. Pregnancy, breastfeeding or plan to become pregnant within the study timeframe 4. Vulnerable adults (i.e., mentally or physically disabled to take care of himself/herself) 5. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects who have PCR confirmed SARS-CoV-2 infection | 3 weeks |
| Proportion of subjects with treatment-emergent adverse events (TEAEs) and severity of TEAEs | 3 weeks |
| Proportion of subjects who subsequently develop COVID-19 symptoms or signs | 3 weeks |
| Proportion of subjects who subsequently develop moderate to severe COVID-19 infection | 3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of days of symptomatic PCR confirmed SARS-CoV-2 infection | 3 weeks |
| Number of days of PCR confirmed SARS-CoV-2 infection | 3 weeks |
Countries
China
Outcome results
None listed