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

Sponsor
Hong Kong Baptist University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05269511
Collaborator
(none)
5,000
Enrollment
1
Location
2
Arms
3.7
Anticipated Duration (Months)
1346.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Chinese herbal medicine is in the form of granules (9 g/sachet), which is comprised of ten medicinal herbs.
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
5000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Efficacy of Chinese Herbal Medicine to Prevent and Treat COVID-19 Close Contacts: A Randomized Controlled Trial
Anticipated Study Start Date :
Mar 10, 2022
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of subjects who have PCR confirmed SARS-CoV-2 infection [3 weeks]

    2. Proportion of subjects with treatment-emergent adverse events (TEAEs) and severity of TEAEs [3 weeks]

    3. Proportion of subjects who subsequently develop COVID-19 symptoms or signs [3 weeks]

    4. Proportion of subjects who subsequently develop moderate to severe COVID-19 infection [3 weeks]

    Secondary Outcome Measures

    1. Number of days of symptomatic PCR confirmed SARS-CoV-2 infection [3 weeks]

    2. Number of days of PCR confirmed SARS-CoV-2 infection [3 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 School of Chinese Medicine, Hong Kong Baptist University Hong Kong Hong Kong China

    Sponsors and Collaborators

    • Hong Kong Baptist University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ZhaoXiang Bian, Professor, Hong Kong Baptist University
    ClinicalTrials.gov Identifier:
    NCT05269511
    Other Study ID Numbers:
    • CHM COVID-19
    First Posted:
    Mar 8, 2022
    Last Update Posted:
    Mar 21, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 21, 2022