Wei Jianyi, Liu Shupeng, Bian Yuexiang, Li Lei, Qian Biyun, Shen Zixuan, Zhang Yan, Abuduaini Adila, Dong Fuchen, Zhang Xin, Li Jinhui, Yu Yongpei, Zhang Weituo, Wang Jun, Zhai Wei, Song Qixiang, Zheng Yu, Pan Weihua, Yu Lanlan, Zhan Qimin, Zhang Ning, Zheng Junhua, Pan Shuming, Yao Chen, Li Hai
Department of Gastroenterology, Renji Hospital, Shanghai Jiao Tong University School of Medicine; NHC Key Laboratory of Digestive Diseases (Renji Hospital, Shanghai Jiaotong University School of Medicine), 1630 Dong Fang Road, Shanghai, 200127, China.
Department of Otorhinolaryngology-Head & Neck Surgery, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Sci Rep. 2025 Jan 31;15(1):3875. doi: 10.1038/s41598-024-75891-3.
Cepharanthine (CEP) is a natural remedy that potently inhibits SARS-CoV-2 activity both in vitro and in vivo. To evaluate the efficacy and safety of CEP compared with placebo in adults with asymptomatic or mild coronavirus disease 2019 (COVID-19), we conducted a proof-of-concept, double-blind, randomized, placebo-controlled trial. Patients were randomized to receive 120 mg/day of CEP, 60 mg/day CEP or placebo for 5 days. Main outcome was the time from randomization to negative nasopharyngeal swab and safety. Among 262 randomized participants, 188 completed the trial among group of 120 mg/day CEP (n = 65), 60 mg/day CEP (n = 68) and placebo (n = 55). Neither 120 mg/day or 60 mg/day CEP shortened the time to negative significantly compared with placebo. However, 60 mg/day CEP showed a slight trend (difference=-0.77 days, hazard ratio (HR) = 1.40, 95% CI 0.97-2.01, p = 0.072). In analysis of participants with good medication compliance, 60 mg/day CEP significantly shortened the time to negative (difference=-0.87 days, HR = 1.56, 95% CI 1.03-2.37, p = 0.035). Adverse events were not different among the three groups, and no serious adverse events occurred. In conclusion, treatment of asymptomatic or mild Covid-19 with 120 mg/day or 60 mg/day did not shorten the time to negative significantly. However, 60 mg/day CEP showed a slight trend which needs future confirmatory trials to validate. (NCT05398705).
千金藤素（CEP）是一种天然药物，在体外和体内均能有效抑制严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）的活性。为了评估与安慰剂相比，CEP对无症状或轻度2019冠状病毒病（COVID-19）成人患者的疗效和安全性，我们进行了一项概念验证、双盲、随机、安慰剂对照试验。患者被随机分为接受120毫克/天的CEP、60毫克/天的CEP或安慰剂，为期5天。主要结局是从随机分组到鼻咽拭子检测呈阴性的时间以及安全性。在262名随机参与者中，188人完成了试验，其中120毫克/天CEP组（n = 65）、60毫克/天CEP组（n = 68）和安慰剂组（n = 55）。与安慰剂相比，120毫克/天或60毫克/天的CEP均未显著缩短转阴时间。然而，60毫克/天的CEP呈现出轻微趋势（差异=-0.77天，风险比（HR）= 1.40，95%置信区间0.97 - 2.01，p = 0.072）。在对药物依从性良好的参与者进行分析时，60毫克/天的CEP显著缩短了转阴时间（差异=-0.87天，HR = 1.56，95%置信区间1.03 - 2.37，p = 0.035）。三组之间的不良事件无差异，且未发生严重不良事件。总之，120毫克/天或60毫克/天治疗无症状或轻度新冠患者并未显著缩短转阴时间。然而，60毫克/天的CEP呈现出轻微趋势，这需要未来的验证性试验来证实。（NCT05398705）
