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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
652
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.
Proportion of subjects who become SARS-CoV-2 positive
Time frame: 4 weeks
Number of days of confirmed SARS-CoV-2 infection
Time frame: 4 weeks
Duration of COVID-19-related symptoms in confirmed SARS-CoV-2 infection cases
Time frame: 4 weeks
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).
Time frame: 4 weeks
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