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

COVID-19 Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05360004
• Other study ID #: REC/21-22/0458
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 2022
• Est. completion date: June 2022

Study information

• Verified date: May 2022
• Source: Hong Kong Baptist University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 652
• Est. completion date: June 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Chinese herbal medicine
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hong Kong Baptist University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who become SARS-CoV-2 positive		4 weeks
Secondary	Number of days of confirmed SARS-CoV-2 infection		4 weeks
Secondary	Duration of COVID-19-related symptoms in confirmed SARS-CoV-2 infection cases		4 weeks
Secondary	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).	4 weeks