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Archive > Volume 17 Issue 3 > 2025,17(3):601-608. DOI:https://doi.org/10.1016/j.chmed.2025.04.005 Prev Next

疏風(fēng)解毒顆粒治療輕型新冠感染：隨機(jī)、雙盲、安慰劑對(duì)照、多中心Ⅲ期臨床研究方案

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Shufeng Jiedu Granule against mild COVID-19: Protocol of the randomized, double-blind, placebo-controlled, multi-center heal-COVID phase III study

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    摘要:
    目的：鑒于奧密克戎毒株的持續(xù)存在，本試驗(yàn)旨在評(píng)估疏風(fēng)解毒顆粒（SFJDG）治療輕型新冠感染患者的安全性與療效，以期為居家治療患者探尋新型治療方案。 方法：本研究為一項(xiàng)隨機(jī)、雙盲、安慰劑對(duì)照的多中心Ⅲ期臨床試驗(yàn)，共納入844例患者，隨機(jī)分為治療組（422例）與對(duì)照組（422例）。受試者接受SFJDG或安慰劑治療，療程7天，用藥劑量為1.2克/袋，每次2袋，每日3次。于第1天和第8天進(jìn)行在院評(píng)估，第3天和第5天實(shí)施電話(huà)評(píng)估，隨訪延續(xù)至第10天和第14天。通過(guò)日記卡記錄患者癥狀評(píng)分及安全性數(shù)據(jù)。主要研究結(jié)局為新冠癥狀達(dá)到持續(xù)臨床康復(fù)所需時(shí)間。當(dāng)70%的患者完成隨訪后，將依據(jù)O’Brien-Flemin-type 累積誤差消耗函數(shù)進(jìn)行中期分析，并進(jìn)行Ⅰ類(lèi)錯(cuò)誤校正（α1=0.015）。 結(jié)果：本Ⅲ期試驗(yàn)聚焦于評(píng)估SFJDG治療輕型COVID-19的有效與安全性，著重考量其在居家管理患者中的實(shí)際應(yīng)用價(jià)值。研究采用隨機(jī)、雙盲、安慰劑對(duì)照設(shè)計(jì)，確保了方法學(xué)的嚴(yán)謹(jǐn)性，且全面的結(jié)局指標(biāo)兼顧了癥狀緩解及治療安全性。通過(guò)關(guān)注癥狀緩解及康復(fù)時(shí)間，本試驗(yàn)契合輕型COVID-19病例管理的臨床要點(diǎn)。研究結(jié)果有望為SFJDG在改善患者癥狀、填補(bǔ)現(xiàn)有抗病毒療法在癥狀管理等方面的空白。 結(jié)論：由于SARS-CoV-2奧密克戎亞譜系持續(xù)存，全球風(fēng)險(xiǎn)評(píng)估仍維持在較高水平。本Ⅲ期研究運(yùn)用科學(xué)嚴(yán)謹(jǐn)?shù)姆椒?，探究SFJDG作為輕型COVID-19治療藥物的有效性與安全性，致力于為居家治療患者提供新的獲批上市藥物。若研究成功，SFJDG有望成為輕型感染治療方案的重要補(bǔ)充，助力公共衛(wèi)生策略應(yīng)對(duì)SARS-CoV-2的持續(xù)影響。

    Abstract:
    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.

    關(guān)鍵詞:
    臨床康復(fù);臨床試驗(yàn);新冠感染;輕型患者;疏風(fēng)解毒顆粒;癥狀緩解;Ⅲ 期臨床研究

    Keywords:


    Project Supported:
    This research was supported by Plans for Major Provincial Science & Technology Projects of Anhui Province (No. 202303a07020007) and Anhui Jiren Pharmaceutical Co., Ltd.

    Clc Number:

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