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

Healthy Participants Clinical Trial

— CHM COVID-19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05269511
• Other study ID #: CHM COVID-19
• Status: Completed
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: June 22, 2022

Study information

• Verified date: April 2023
• Source: Hong Kong Baptist University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2163
• Est. completion date: June 22, 2022
• Est. primary completion date: June 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Chinese herbal medicine is in the form of granules (9 g/sachet), which is comprised of ten medicinal herbs.
Oral administration, twice per day.

Locations

Country	Name	City	State
China	School of Chinese Medicine, Hong Kong Baptist University	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Hong Kong Baptist University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who have PCR confirmed SARS-CoV-2 infection		3 weeks
Primary	Proportion of subjects with treatment-emergent adverse events (TEAEs) and severity of TEAEs		3 weeks
Primary	Proportion of subjects who subsequently develop COVID-19 symptoms or signs		3 weeks
Primary	Proportion of subjects who subsequently develop moderate to severe COVID-19 infection		3 weeks
Secondary	Number of days of symptomatic PCR confirmed SARS-CoV-2 infection		3 weeks
Secondary	Number of days of PCR confirmed SARS-CoV-2 infection		3 weeks