Efficacy of Chinese Herbal Medicine to Prevent and Treat COVID-19 Close Contacts

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Chinese herbal medicine is in the form of granules (9 g/sachet), which is comprised of ten medicinal herbs.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Household contact exposure to individuals with SARS-CoV-2 infection Aged ≥18 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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Chinese Herbal Medicine | Drug: Chinese herbal medicine is in the form of granules (9 g/sachet), which is comprised of ten medicinal herbs.<br>* Oral administration, twice per day.<br>* Other names: Chinese herbal medicine;|
| No Intervention: Control group<br>usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |