AUTHOR=Du Peipei , Lam Wai Ching , Leung Choryin , Li Huijuan , Lyu Zipan , Yuen Chun Sum , Cheung Chun Hoi , Lam Tsz Fung , Bian Zhaoxiang , Zhong Linda 

TITLE=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

JOURNAL=Frontiers in Immunology

VOLUME=15

YEAR=2024

URL=https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2024.1359331

DOI=10.3389/fimmu.2024.1359331

ISSN=1664-3224

ABSTRACT=<sec><title>Objectives</title><p>To evaluate the efficacy and safety of CHM in the prevention of COVID-19 infection and treatment for COVID-19 related symptoms.</p></sec><sec><title>Design</title><p>Prospective open-label randomized controlled trial.</p></sec><sec><title>Setting</title><p>Participants’ home in Hong Kong.</p></sec><sec><title>Participants</title><p>Participants who had household close contact with COVID-19-infected family members.</p></sec><sec><title>Interventions</title><p>Close contacts were stratified into 4 groups (cohort A, B, C, D) based on symptoms and infection status and were randomized in 4:1 ratio to receive CHM granules (9g/sachet, two times daily) or blank control for 7 days with 2 weeks of follow-up.</p></sec><sec><title>Main outcome measures</title><p>The primary outcome measure was the rate of positive nucleic acid tests. Secondary outcomes were the proportion of developed COVID-19 related symptoms and adverse events during the whole 3-week study period. Subgroup analysis was used to evaluate demographic factors associated with positive infection rates.</p></sec><sec><title>Results</title><p>A total of 2163 contacts were enrolled and randomly assigned to the CHM group (1720 contacts) and blank control (443 contacts) group. During the 21 days, the rate of PCR-positive cases in cohort A was markedly lower in the CHM group (3.6%) compared to the control group (7.0%) (<italic>P</italic>=0.036). Overall, the rate of infection in the CHM group was significantly lower than that in the control group (10.69% <italic>vs</italic>. 6.03%; RR 0.56, 95% CI 0.39-0.82) after 7-day treatment. No serious adverse events were reported during the medication period.</p></sec><sec><title>Conclusion</title><p>The preliminary findings indicate that CHM may be effective and safe in preventing COVID-19. Future double-blind, randomized controlled trials and long-term follow-up are needed to fully evaluate the efficacy of CHM in a larger contact population.</p></sec><sec><title>Clinical trial registration</title><p>ClinicalTrials.gov, identifier NCT05269511</p></sec>