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This is a randomized, blank-controlled study in adults with household contact exposure to individuals with SARS-CoV-2 infection. All subjects in the study will be household contacts with close exposure to the first household member known to be newly infected with SARS-CoV-2. Subjects in each cohort will be randomly assigned to the Chinese herbal medicine treatment group or blank control group in a 4:1 ratio, followed by 1 week of the treatment period and 2 weeks of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Chinese Herbal Medicine |
|
| Control group | No Intervention | usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chinese herbal medicine is in the form of granules (9 g/sachet), which is comprised of ten medicinal herbs. | Drug | Oral administration, twice per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who have PCR confirmed SARS-CoV-2 infection | 3 weeks | |
| Proportion of subjects with treatment-emergent adverse events (TEAEs) and severity of TEAEs | 3 weeks | |
| Proportion of subjects who subsequently develop COVID-19 symptoms or signs | 3 weeks | |
| Proportion of subjects who subsequently develop moderate to severe COVID-19 infection | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days of symptomatic PCR confirmed SARS-CoV-2 infection | 3 weeks | |
| Number of days of PCR confirmed SARS-CoV-2 infection | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aiping Lyu | School of Chinese Medicine, Hong Kong Baptist University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Chinese Medicine, Hong Kong Baptist University | Hong Kong | Hong Kong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38799438 | Derived | Du P, Lam WC, Leung C, Li H, Lyu Z, Yuen CS, Cheung CH, Lam TF, Bian Z, Zhong L. Efficacy and safety of Chinese herbal medicine to prevent and treat COVID-19 household close contacts in Hong Kong: an open-label, randomized controlled trial. Front Immunol. 2024 May 10;15:1359331. doi: 10.3389/fimmu.2024.1359331. eCollection 2024. |
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All the individual participant data that underlie the results reported in the published article will be shared after de-identification.
Beginning 3 months and ending 5 years following article publication
Researchers who provide a methodologically sound proposal
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