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Cited by 6COVID-19 Clinical Research StudiesSARS-CoV-2 and COVID-19 ResearchTraditional Chinese Medicine Clinical Research

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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

Open access
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·2025·Scientific Reports
DOI 10.1038/s41598-024-75891-3PMC PMC11785718

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Abstract

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).

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Metadata

Authors
Wei, J., Liu, S., Bian, Y., Li, L., Qian, B., Shen, Z., Zhang, Y., Abuduaini, A., Dong, F., Zhang, X., Li, J., Yu, Y., Zhang, W., Wang, J., Zhai, W., Song, Q., Zheng, Y., Pan, W., Yu, L., Zhan, Q., Zhang, N., Zheng, J., Pan, S., Yao, C., & Li, H.
Affiliations
  • Shanghai Jiao Tong University (CN)
  • Peking University (CN)
Corresponding author
  • Pan, Shuming
  • Yao, Chen
  • Li, Hai
ORCID
Venue
Scientific Reports
Publisher
Springer Science and Business Media LLC
Published
2025-01-31
Volume
15
Issue
1
Pages
3875-3875
ISSN
2045-2322 (ISSN-L)
DOI
10.1038/s41598-024-75891-3
PMC
PMC11785718
OpenAlex
W4407005494
Cited by
6
References
2
Citations by year
2026: 2 · 2025: 3
FWCI
3.81
Type
journal article
Language
en
Open access
Licence
Locations
  • Scientific Reports (publishedVersion, cc-by)
  • medRxiv (acceptedVersion)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
Shanghai Municipal Education Commission-Gaofeng Clinical Medicine Grant Support (20152213)
Topics
  • Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
  • Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
  • Health Sciences › Medicine › Complementary and alternative medicine › Traditional Chinese Medicine Clinical Research
Keywords
cepharanthine, COVID-19 pandemic, SARS-CoV-2, asymptomatic infection, mild COVID-19, oral antiviral therapy, nasopharyngeal swab, adverse events, medication adherence, natural remedies
MeSH terms
COVID-19, SARS-CoV-2, COVID-19 Drug Treatment, Administration, Oral, Adult, Aged, Antiviral Agents, Double-Blind Method, Female, Humans, Male, Middle Aged, Treatment Outcome, Benzylisoquinolines, Benzodioxoles

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