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

Hong Kong Baptist University2,163 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

2,163

Conditions

Healthy Participants

Interventions

Chinese herbal medicine is in the form of granules (9 g/sachet), which is comprised of ten medicinal herbs.DRUG

Oral administration, twice per day.

Eligibility

Sex: ALLMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

School of Chinese Medicine, Hong Kong Baptist University

Hong Kong, Hong Kong, China

Outcomes

Primary Outcomes

Proportion of subjects who have PCR confirmed SARS-CoV-2 infection

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 COVID-19 symptoms or signs

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 symptomatic PCR confirmed SARS-CoV-2 infection

Time frame: 3 weeks

Number of days of PCR confirmed SARS-CoV-2 infection

Time frame: 3 weeks

Data from ClinicalTrials.gov

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