The Use of Chinese Herbal Medicine and Vitamin C by Hospital Care Workers in HK to Prevent COVID-19 (CHM-Cov-19-RCT)
Primary Purpose
COVID-19
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Chinese herbal medicine
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring Chinese herbal medicine, Prevention, Health Care Worker
Eligibility Criteria
Inclusion Criteria:
- Health care workers in Hong Kong Mobile Cabin Hospital;
- Asymptomatic and test negative for SARS-CoV-2;
- Aged ≥18;
- Voluntarily signing a written informed consent form;
Exclusion Criteria:
- With major medical illness or renal insufficiency;
- With hypersensitivity to Chinese herbal medicine;
- Pregnancy or lactation.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CHM+Vc
Vc
Arm Description
Participants in CHM+VC group are required to consume vitamin C 1000mg/day and 1 sachet (9 g) of granules daily (1 hour after meal by dissolving 1 sachet of 9g granules in 150 ml of hot water and drink it orally) .
Participants will receive vitamin C 1000mg/day for 14 days
Outcomes
Primary Outcome Measures
Proportion of subjects who become SARS-CoV-2 positive
Secondary Outcome Measures
Number of days of confirmed SARS-CoV-2 infection
Duration of COVID-19-related symptoms in confirmed SARS-CoV-2 infection cases
Safety endpoint
Proportion of subjects with treatment-emergent adverse events (TEAEs) and severity of TEAEs (TEAEs are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition).
Full Information
NCT ID
NCT05360004
First Posted
April 27, 2022
Last Updated
May 3, 2022
Sponsor
Hong Kong Baptist University
1. Study Identification
Unique Protocol Identification Number
NCT05360004
Brief Title
The Use of Chinese Herbal Medicine and Vitamin C by Hospital Care Workers in HK to Prevent COVID-19
Acronym
CHM-Cov-19-RCT
Official Title
The Use of Chinese Herbal Medicine and Vitamin C by Hospital Care Workers in Hong Kong Mobile Cabin Hospital to Prevent COVID-19 Transmission: A Prospective, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hong Kong Baptist University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective randomized controlled trial study to explore whether the combination of Chinese herbal medicine and Vitamin C is effective and safe to prevent COVID-19 transmission among health care workers in Hong Kong Mobile Cabin Hospital governed by the Hong Kong Hospital Authority who have been caring for patients with COVID-19. A total of 652 adults will be enrolled. Eligible subjects who provide written informed consent will be assessed for inclusion/exclusion criteria.
All participants are asymptomatic and test negative for SARS-CoV-2 at the study's commencement. Subjects with major medical illness, renal insufficiency and hypersensitivity to Chinese herbal medicine will be excluded. All participants will receive Vitamin C (VC) supplementation and 28 packets of the herbal medicine free of charge and are advised to consume daily for 14 days. After written informed consent, the subjects will be included and randomly allocated to either CHM+VC group or VC treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Chinese herbal medicine, Prevention, Health Care Worker
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized, open-labelled, controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
652 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CHM+Vc
Arm Type
Experimental
Arm Description
Participants in CHM+VC group are required to consume vitamin C 1000mg/day and 1 sachet (9 g) of granules daily (1 hour after meal by dissolving 1 sachet of 9g granules in 150 ml of hot water and drink it orally) .
Arm Title
Vc
Arm Type
Placebo Comparator
Arm Description
Participants will receive vitamin C 1000mg/day for 14 days
Intervention Type
Drug
Intervention Name(s)
Chinese herbal medicine
Intervention Description
CHM is in the form of granules (9 g/sachet), which is comprised of 10 commonly used medicinal herbs: Codonopsis Radix, Astragali Radix, Lonicerae Japonicae Flos, Saposhnikovia Radix, Schizonepetae Herba, Mori Folium, Poria, Atractylodis Rhizoma, Atractylodis Macrocephala Rhizoma, Glycyrrhizae Radix et Rhizoma.
Primary Outcome Measure Information:
Title
Proportion of subjects who become SARS-CoV-2 positive
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Number of days of confirmed SARS-CoV-2 infection
Time Frame
4 weeks
Title
Duration of COVID-19-related symptoms in confirmed SARS-CoV-2 infection cases
Time Frame
4 weeks
Title
Safety endpoint
Description
Proportion of subjects with treatment-emergent adverse events (TEAEs) and severity of TEAEs (TEAEs are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition).
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Health care workers in Hong Kong Mobile Cabin Hospital;
Asymptomatic and test negative for SARS-CoV-2;
Aged ≥18;
Voluntarily signing a written informed consent form;
Exclusion Criteria:
With major medical illness or renal insufficiency;
With hypersensitivity to Chinese herbal medicine;
Pregnancy or lactation.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
All participant data will be de-identified.
Learn more about this trial
The Use of Chinese Herbal Medicine and Vitamin C by Hospital Care Workers in HK to Prevent COVID-19
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