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<p>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&#xa0;mg/day of CEP, 60&#xa0;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&#xa0;mg/day CEP (<i>n</i> = 65), 60&#xa0;mg/day CEP (<i>n</i> = 68) and placebo (<i>n</i> = 55). Neither 120&#xa0;mg/day or 60&#xa0;mg/day CEP shortened the time to negative significantly compared with placebo. However, 60&#xa0;mg/day CEP showed a slight trend (difference=-0.77 days, hazard ratio (HR) = 1.40, 95% CI 0.97–2.01, <i>p</i> = 0.072). In analysis of participants with good medication compliance, 60&#xa0;mg/day CEP significantly shortened the time to negative (difference=-0.87 days, HR = 1.56, 95% CI 1.03–2.37, <i>p</i> = 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&#xa0;mg/day or 60&#xa0;mg/day did not shorten the time to negative significantly. However, 60&#xa0;mg/day CEP showed a slight trend which needs future confirmatory trials to validate. (NCT05398705).</p>

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Safety and efficacy of oral administrated cepharanthine in non-hospitalized, asymptomatic or mild COVID-19 patients: a Double-blind, randomized, placebo-controlled trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年1月31日

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  • Jianyi Wei,
  • Shupeng Liu,
  • Yuexiang Bian,
  • Lei Li,
  • Biyun Qian,
  • Zixuan Shen,
  • Yan Zhang,
  • Adila Abuduaini,
  • Fuchen Dong,
  • Xin Zhang,
  • Jinhui Li,
  • Yongpei Yu,
  • Weituo Zhang,
  • Jun Wang,
  • Wei Zhai,
  • Qixiang Song,
  • Yu Zheng,
  • Weihua Pan,
  • Lanlan Yu,
  • Qimin Zhan,
  • Ning Zhang,
  • Junhua Zheng,
  • Shuming Pan,
  • Chen Yao,
  • Hai Li

摘要

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).