tetano
Editor, Senior Moderator
Sci Rep
. 2025 Jan 31;15(1):3875.
doi: 10.1038/s41598-024-75891-3. Safety and efficacy of oral administrated cepharanthine in non-hospitalized, asymptomatic or mild COVID-19 patients: a Double-blind, randomized, placebo-controlled trial : Author detials
Jianyi Wei[SUP] #[/SUP][SUP] 1 [/SUP], Shupeng Liu[SUP] #[/SUP][SUP] 1 [/SUP], Yuexiang Bian[SUP] #[/SUP][SUP] 1 [/SUP], Lei Li[SUP] #[/SUP][SUP] 2 [/SUP], Biyun Qian[SUP] 3 [/SUP], Zixuan Shen[SUP] 1 [/SUP], Yan Zhang[SUP] 1 [/SUP], Adila Abuduaini[SUP] 1 [/SUP], Fuchen Dong[SUP] 1 [/SUP], Xin Zhang[SUP] 1 [/SUP], Jinhui Li[SUP] 1 [/SUP], Yongpei Yu[SUP] 4 [/SUP], Weituo Zhang[SUP] 5 [/SUP], Jun Wang[SUP] 6 [/SUP], Wei Zhai[SUP] 7 [/SUP], Qixiang Song[SUP] 7 [/SUP], Yu Zheng[SUP] 8 [/SUP], Weihua Pan[SUP] 9 [/SUP], Lanlan Yu[SUP] 4 [/SUP], Qimin Zhan[SUP] 10 [/SUP], Ning Zhang[SUP] 10 [/SUP], Junhua Zheng[SUP] 7 [/SUP], Shuming Pan[SUP] 11 [/SUP], Chen Yao[SUP] 12 [/SUP], Hai Li[SUP] 13 [/SUP]
Affiliations
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).
Keywords: COVID-19; Cepharanthine; Effectiveness; SARS-CoV-2; Safety.
. 2025 Jan 31;15(1):3875.
doi: 10.1038/s41598-024-75891-3. Safety and efficacy of oral administrated cepharanthine in non-hospitalized, asymptomatic or mild COVID-19 patients: a Double-blind, randomized, placebo-controlled trial : Author detials
Jianyi Wei[SUP] #[/SUP][SUP] 1 [/SUP], Shupeng Liu[SUP] #[/SUP][SUP] 1 [/SUP], Yuexiang Bian[SUP] #[/SUP][SUP] 1 [/SUP], Lei Li[SUP] #[/SUP][SUP] 2 [/SUP], Biyun Qian[SUP] 3 [/SUP], Zixuan Shen[SUP] 1 [/SUP], Yan Zhang[SUP] 1 [/SUP], Adila Abuduaini[SUP] 1 [/SUP], Fuchen Dong[SUP] 1 [/SUP], Xin Zhang[SUP] 1 [/SUP], Jinhui Li[SUP] 1 [/SUP], Yongpei Yu[SUP] 4 [/SUP], Weituo Zhang[SUP] 5 [/SUP], Jun Wang[SUP] 6 [/SUP], Wei Zhai[SUP] 7 [/SUP], Qixiang Song[SUP] 7 [/SUP], Yu Zheng[SUP] 8 [/SUP], Weihua Pan[SUP] 9 [/SUP], Lanlan Yu[SUP] 4 [/SUP], Qimin Zhan[SUP] 10 [/SUP], Ning Zhang[SUP] 10 [/SUP], Junhua Zheng[SUP] 7 [/SUP], Shuming Pan[SUP] 11 [/SUP], Chen Yao[SUP] 12 [/SUP], Hai Li[SUP] 13 [/SUP]
Affiliations
- PMID: 39890847
- PMCID: PMC11785718
- 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).
Keywords: COVID-19; Cepharanthine; Effectiveness; SARS-CoV-2; Safety.