Objective: Since Omicron will likely persist, this trial evaluates the safety and efficacy of Shufeng Jiedu Granule (SFJDG) for mild Omicron infection, aims at finding new therapies especially for home-treated patients. Methods: This randomized, double-blind, placebo-controlled, multi-center phase III trial involves 844 patients, divided into a treatment group (422) and control group (422). Participants will receive SFJDG or placebo for 7 d (1.2 g/bag, 2 bags, 3 times/d). Hospital evaluations will be done on days 1 and 8, with telephone assessments on days 3 and 5. Follow-up continues on days 10 and 14. Diary cards will track symptom scores and safety data. The primary outcome is the time to sustained clinical recovery from corona virus disease 2019 (COVID-19) symptoms. An interim analysis will occur after 70 % of patients complete follow-up, with Type I error correction (a1 = 0.015) at interim analysis based on O’Brien-Flemingtype cumulative error spending function. Results: This phase III trial evaluates the efficacy and safety of SFJDG for mild COVID-19, focusing on realworld applicability for home-managed patients. The study’s randomized, double-blind, placebocontrolled design ensures methodological rigor, while its comprehensive outcome measures address both symptom recovery and treatment safety. By emphasizing symptom resolution and recovery time, the trial aligns with the clinical priorities for managing mild cases of COVID-19. The findings could offer valuable insights into SFJDG’s role in improving patient outcomes and addressing gaps left by existing antiviral therapies, particularly in symptom management. Conclusion: The global risk assessment remains high due to the ongoing virulence of SARS-CoV-2 Omicron sub-lineages. This Phase III study adopts a robust methodology to investigate SFJDG as a treatment for mild COVID-19 as well as it’s effectiveness and safety. Furthermore, this study aim to provide sufficient scientific evidence for the market registration of SFJDG especially for home-treated patients. If successful, SFJDG could be a meaningful addition to therapeutic options for mild infections, supporting public health strategies in managing the ongoing impact of SARS-CoV-2.
关键词:
临床康复;临床试验;新冠感染;轻型患者;疏风解毒颗粒;症状缓解;Ⅲ 期临床研究
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This research was supported by Plans for Major Provincial Science & Technology Projects of Anhui Province (No. 202303a07020007) and Anhui Jiren Pharmaceutical Co., Ltd.
Li Yang a,, Thomas Friedemann c,, Jun Pan a, Xiangyu Li a, Fuxiang Wang b, Yuanlong Lin b, Qiang Zhu a, Sven Schr?der c, Qingsong Liu d,?, Hongzhou Lu b,?. Shufeng Jiedu Granule against mild COVID-19: Protocol of the randomized, double-blind, placebo-controlled, multi-center heal-COVID phase III study[J]. Chinese Herbal Medicines (CHM),2025,17(3):601-608
