The Use of Chinese Herbal Medicine and Vitamin C by Hospital Care Workers in HK to Prevent COVID-19

Phase 2

• Conditions: COVID-19
• Interventions: Drug: Chinese herbal medicine

• Registration Number: NCT05360004
• Lead Sponsor: Hong Kong Baptist University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-27
• Status Verified: 2022-05
• Study Start: 2022-05
• Primary Completion: 2022-05
• Study First Submitted QC: 2022-05-03
• Last Update Submitted: 2022-05-03
• Study First Posted: 2022-05-04
• Last Update Posted: 2022-05-04
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 652

Inclusion Criteria

1. Health care workers in Hong Kong Mobile Cabin Hospital;
2. Asymptomatic and test negative for SARS-CoV-2;
3. Aged ≥18;
4. Voluntarily signing a written informed consent form;

Exclusion Criteria

1. With major medical illness or renal insufficiency;
2. With hypersensitivity to Chinese herbal medicine;
3. Pregnancy or lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vc	Chinese herbal medicine	Participants will receive vitamin C 1000mg/day for 14 days
CHM+Vc	Chinese herbal medicine	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) .

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who become SARS-CoV-2 positive	4 weeks

Secondary Outcome Measures

Name	Time	Method
Number of days of confirmed SARS-CoV-2 infection	4 weeks
Duration of COVID-19-related symptoms in confirmed SARS-CoV-2 infection cases	4 weeks
Safety endpoint	4 weeks	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).