Safety and efficacy of oral administrated cepharanthine in non-hospitalized, asymptomatic or mild COVID-19 patients: a Double-blind, randomized, placebo-controlled trial
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-bli...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Nature Portfolio
2025-01-01
|
| Series: | Scientific Reports |
| Subjects: | |
| Online Access: | https://doi.org/10.1038/s41598-024-75891-3 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832571739950809088 |
|---|---|
| author | 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 |
| author_facet | 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 |
| author_sort | Jianyi Wei |
| collection | DOAJ |
| description | 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). |
| format | Article |
| id | doaj-art-8faae893d98d4de1846819f8855c0839 |
| institution | Kabale University |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj-art-8faae893d98d4de1846819f8855c08392025-02-02T12:20:31ZengNature PortfolioScientific Reports2045-23222025-01-0115111010.1038/s41598-024-75891-3Safety and efficacy of oral administrated cepharanthine in non-hospitalized, asymptomatic or mild COVID-19 patients: a Double-blind, randomized, placebo-controlled trialJianyi Wei0Shupeng Liu1Yuexiang Bian2Lei Li3Biyun Qian4Zixuan Shen5Yan Zhang6Adila Abuduaini7Fuchen Dong8Xin Zhang9Jinhui Li10Yongpei Yu11Weituo Zhang12Jun Wang13Wei Zhai14Qixiang Song15Yu Zheng16Weihua Pan17Lanlan Yu18Qimin Zhan19Ning Zhang20Junhua Zheng21Shuming Pan22Chen Yao23Hai Li24Department 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)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)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)Department of Otorhinolaryngology-Head & Neck Surgery, Xinhua Hospital, Shanghai Jiao Tong University School of MedicineHongqiao International Institute of Medicine, Shanghai Tongren Hospital/School of Public Health, Shanghai Jiao Tong University School of MedicineDepartment 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)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)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)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)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)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)Peking University Clinical Research Institute, Peking University First HospitalClinical Research Center, Shanghai Jiao Tong University School of MedicineDepartment of Interventional Oncology, Renji Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Urology, Renji Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Urology, Renji Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Respiratory Medicine, Renji Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Pediatric Surgery, Xinhua Hospital, Shanghai Jiao Tong University School of MedicinePeking University Clinical Research Institute, Peking University First HospitalPeking University - Yunnan Baiyao International Medical Research CenterPeking University - Yunnan Baiyao International Medical Research CenterDepartment of Urology, Renji Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Emergency, Xinhua Hospital, Shanghai Jiao Tong University School of MedicinePeking University Clinical Research Institute, Peking University First HospitalDepartment 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)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).https://doi.org/10.1038/s41598-024-75891-3CepharanthineCOVID-19EffectivenessSafetySARS-CoV-2 |
| spellingShingle | 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 Safety and efficacy of oral administrated cepharanthine in non-hospitalized, asymptomatic or mild COVID-19 patients: a Double-blind, randomized, placebo-controlled trial Scientific Reports Cepharanthine COVID-19 Effectiveness Safety SARS-CoV-2 |
| title | Safety and efficacy of oral administrated cepharanthine in non-hospitalized, asymptomatic or mild COVID-19 patients: a Double-blind, randomized, placebo-controlled trial |
| title_full | Safety and efficacy of oral administrated cepharanthine in non-hospitalized, asymptomatic or mild COVID-19 patients: a Double-blind, randomized, placebo-controlled trial |
| title_fullStr | Safety and efficacy of oral administrated cepharanthine in non-hospitalized, asymptomatic or mild COVID-19 patients: a Double-blind, randomized, placebo-controlled trial |
| title_full_unstemmed | Safety and efficacy of oral administrated cepharanthine in non-hospitalized, asymptomatic or mild COVID-19 patients: a Double-blind, randomized, placebo-controlled trial |
| title_short | Safety and efficacy of oral administrated cepharanthine in non-hospitalized, asymptomatic or mild COVID-19 patients: a Double-blind, randomized, placebo-controlled trial |
| title_sort | safety and efficacy of oral administrated cepharanthine in non hospitalized asymptomatic or mild covid 19 patients a double blind randomized placebo controlled trial |
| topic | Cepharanthine COVID-19 Effectiveness Safety SARS-CoV-2 |
| url | https://doi.org/10.1038/s41598-024-75891-3 |
| work_keys_str_mv | AT jianyiwei safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT shupengliu safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT yuexiangbian safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT leili safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT biyunqian safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT zixuanshen safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT yanzhang safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT adilaabuduaini safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT fuchendong safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT xinzhang safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT jinhuili safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT yongpeiyu safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT weituozhang safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT junwang safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT weizhai safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT qixiangsong safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT yuzheng safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT weihuapan safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT lanlanyu safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT qiminzhan safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT ningzhang safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT junhuazheng safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT shumingpan safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT chenyao safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial AT haili safetyandefficacyoforaladministratedcepharanthineinnonhospitalizedasymptomaticormildcovid19patientsadoubleblindrandomizedplacebocontrolledtrial |