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

Not Applicable

Completed

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

• Registration Number: NCT05269511
• Lead Sponsor: Hong Kong Baptist University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-07
• Study First Posted: 2022-03-08
• Study Start: 2022-03-14
• Primary Completion: 2022-06-22
• Study Completion: 2022-06-22
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-19
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2163

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Chinese herbal medicine is in the form of granules (9 g/sachet), which is comprised of ten medicinal herbs.	Chinese Herbal Medicine

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who have PCR confirmed SARS-CoV-2 infection	3 weeks
Proportion of subjects who subsequently develop COVID-19 symptoms or signs	3 weeks
Proportion of subjects with treatment-emergent adverse events (TEAEs) and severity of TEAEs	3 weeks
Proportion of subjects who subsequently develop moderate to severe COVID-19 infection	3 weeks

Secondary Outcome Measures

Name	Time	Method
Number of days of PCR confirmed SARS-CoV-2 infection	3 weeks
Number of days of symptomatic PCR confirmed SARS-CoV-2 infection	3 weeks

Trial Locations

Locations (1)

School of Chinese Medicine, Hong Kong Baptist University; 🇨🇳 Hong Kong, Hong Kong, China