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Clinical trial

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

ID
Name
CHM COVID-19
Description
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.
Trial arms
Trial start
2022-03-14
Estimated PCD
2022-06-22
Trial end
2022-06-22
Status
Completed
Treatment
Chinese herbal medicine is in the form of granules (9 g/sachet), which is comprised of ten medicinal herbs.
Oral administration, twice per day.
Arms:
Treatment group
Other names:
Chinese herbal medicine
Size
2163
Primary endpoint
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
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 2163, 'type': 'ACTUAL'}}
Updated at
2023-04-20

1 organization

1 product

1 indication

Organization
Hong Kong Baptist University
Product
Chinese herbal medicine
Indication
Healthy Participants