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

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

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 Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Chinese herbal medicine is in the form of granules (9 g/sachet), which is comprised of ten medicinal herbs.

• Study Type: Interventional
• Enrollment (Actual): 2163
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhaoxiang BIAN, MD, PhD; Phone Number: +852 3411 6521; Email: bzxiang@hkbu.edu.hk
• Study Contact Backup: Name: Linda Zhong; Phone Number: +852 3411 6523; Email: ldzhong@hkbu.edu.hk

Study Locations

• China
  • Hong Kong
    • Hong Kong, Hong Kong, China
      • School of Chinese Medicine, Hong Kong Baptist University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Chinese Herbal Medicine	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.; Other Names: Chinese herbal medicine
No Intervention: Control group; usual care

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Hong Kong Baptist University
• Investigators: Study Director: Aiping Lyu, School of Chinese Medicine, Hong Kong Baptist University

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Actual): June 22, 2022
• Study Completion (Actual): June 22, 2022

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CHM COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All the individual participant data that underlie the results reported in the published article will be shared after de-identification.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No