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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 : Author detials

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机构: [1]Department of Gastroenterology, Renji Hospital, Shanghai Jiao Tong University School of Medicine [2]NHC Key Laboratory of Digestive Diseases (Renji Hospital, Shanghai Jiaotong University School of Medicine), 1630 Dong Fang Road, Shanghai 200127, China. [3]Department of Emergency, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Yangpu District, Shanghai, China. [4]Peking University Clinical Research Institute, Peking University First Hospital, Beijing 100083, China. [5]Clinical Research Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China. [6]Department of Interventional Oncology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Rd, Pudong, Shanghai 200127, China. [7]Department of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. [8]Department of Respiratory Medicine, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. [9]Department of Otorhinolaryngology-Head & Neck Surgery, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. [10]Peking University - Yunnan Baiyao International Medical Research Center, Beijing, China. [11]Hongqiao International Institute of Medicine, Shanghai Tongren Hospital/School of Public Health, Shanghai Jiao Tong University School of Medicine, Shanghai, China. [12]Department of Pediatric Surgery, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
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关键词: Cepharanthine COVID-19 Effectiveness Safety SARS-CoV-2

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).© 2024. The Author(s).

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大类 | 3 区 综合性期刊
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第一作者机构: [1]Department of Gastroenterology, Renji Hospital, Shanghai Jiao Tong University School of Medicine [2]NHC Key Laboratory of Digestive Diseases (Renji Hospital, Shanghai Jiaotong University School of Medicine), 1630 Dong Fang Road, Shanghai 200127, China.
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通讯机构: [1]Department of Gastroenterology, Renji Hospital, Shanghai Jiao Tong University School of Medicine [2]NHC Key Laboratory of Digestive Diseases (Renji Hospital, Shanghai Jiaotong University School of Medicine), 1630 Dong Fang Road, Shanghai 200127, China.
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