COVID-19
Conditions
Keywords
Chinese herbal medicine, Prevention, Health Care Worker
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.
Interventions
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.
Sponsors
Hong Kong Baptist University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomized, open-labelled, controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects who become SARS-CoV-2 positive | 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Outcome results
None listed