Sikkerhed og effekt af cepharanthine mod mild COVID-19
Cepharanthine (CEP) er en naturlig behandling, der viser sig at hæmme SARS-CoV-2 aktivitet effektivt både in vitro og in vivo. I en kontrolleret, dobbeltblind, randomiseret undersøgelse blev effekten og sikkerheden af CEP sammenlignet med placebo hos voksne med asymptomatisk eller mild COVID-19 (Jianyi Wei et al., 2025) [source_link].
Studiet omfattede 262 randomiserede deltagere, som blev opdelt i tre interventionsgrupper: 120 mg/dag CEP, 60 mg/dag CEP og placebo. Deltagerne modtog behandling i 5 dage, hvor hovedfokus var på tiden fra randomisering til negativ nasopharyngeal podning samt sikkerhedsprofilen for de forskellige behandlinger.
Hovedresultatet viste, at hverken 120 mg/dag eller 60 mg/dag CEP signifikant reducerede tiden til negativ podning sammenlignet med placebo. Dog viste 60 mg/dag CEP en tendens til en reduktion i tiden (forskel = -0,77 dage, hazard ratio (HR) = 1,40, 95% CI 0,97-2,01, p = 0,072). I analysen af deltagere med god medicinsk compliance viste 60 mg/dag CEP en signifikant forkortelse af tiden til negativ podning (forskel = -0,87 dage, HR = 1,56, 95% CI 1,03-2,37, p = 0,035). Der blev ikke observeret signifikante forskelle i bivirkninger mellem grupperne, og der opstod ingen alvorlige bivirkninger.
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#Intern medicin: infektionsmedicin #Gastroenterologi #Klinisk farmakologi
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generer et html link ud fra **Title:** Efficacy and Safety of Cepharanthine in Adults with Asymptomatic or Mild COVID-19: A Randomized Controlled Trial
**Authors:**
– 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
**Affiliations:**
1. Department of Gastroenterology, Renji Hospital, Shanghai Jiao Tong University School of Medicine; NHC Key Laboratory of Digestive Diseases, Shanghai, China.
2. Department of Otorhinolaryngology-Head & Neck Surgery, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
3. Hongqiao International Institute of Medicine, Shanghai Tongren Hospital/School of Public Health, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
4. Peking University Clinical Research Institute, Peking University First Hospital, Beijing, 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, Shanghai, 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 Pediatric Surgery, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
10. Peking University – Yunnan Baiyao International Medical Research Center, Beijing, China.
11. Department of Emergency, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
12. Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.
13. Department of Gastroenterology, Renji Hospital, Shanghai Jiao Tong University School of Medicine; NHC Key Laboratory of Digestive Diseases, Shanghai, China.
**DOI:** 10.1038/s41598-024-75891-3
**PMID:** 39890847
**PMCID:** PMC11785718
**Publication Date:** January 31, 2025
**Journal:** Scientific Reports
**Abstract:**
Cepharanthine (CEP) is a natural remedy that potently inhibits SARS-CoV-2 activity both in vitro and in vivo. This study aimed to evaluate the efficacy and safety of CEP compared with placebo in adults with asymptomatic or mild COVID-19 through a proof-of-concept, double-blind, randomized, placebo-controlled trial. Patients were randomized to receive either 120 mg/day of CEP, 60 mg/day of CEP, or placebo for 5 days. The primary outcome measured was the time from randomization to a negative nasopharyngeal swab, alongside safety assessments.
Among 262 randomized participants, 188 completed the trial—65 in the 120 mg/day CEP group, 68 in the 60 mg/day CEP group, and 55 in the placebo group. Neither the 120 mg/day nor the 60 mg/day dosages significantly shortened the time to a negative swab compared to placebo. However, a slight trend was observed with the 60 mg/day CEP (difference = -0.77 days, hazard ratio (HR) = 1.40, 95% CI 0.97-2.01, p = 0.072). In participants with good medication compliance, the 60 mg/day CEP group 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 comparable among the three groups, with no serious adverse events reported.
In conclusion, treatment of asymptomatic or mild COVID-19 with 120 mg/day or 60 mg/day of CEP did not significantly reduce the time to a negative swab. However, the 60 mg/day dosage showed a trend towards efficacy that requires further confirmatory trials. (NCT05398705)
**Keywords:** COVID-19, Cepharanthine, Effectiveness, SARS-CoV-2, Safety.
**Publication Types:** Randomized Controlled Trial
**MeSH Terms:**
– Administration, Oral
– Adult
– Aged
– Antiviral Agents / administration & dosage
– Antiviral Agents / adverse effects
– Antiviral Agents / therapeutic use
– Benzodioxoles
– Benzylisoquinolines / administration & dosage
– Benzylisoquinolines / therapeutic use
– COVID-19 / virology
– COVID-19 Drug Treatment
– Double-Blind Method
– Female
– Humans
– Male
– Middle Aged
– SARS-CoV-2 / drug effects
– Treatment Outcome
**Substances:**
– Cepharanthine
– Benzylisoquinolines
– Antiviral Agents
– Benzodioxoles
### Sikkerhed og Effekt af Cepharanthine mod Mild COVID-19
I takt med den globale pandemi har forskningen i behandlinger og forebyggelse af COVID-19 fået en central plads i sundhedsvæsenet. Cepharanthine, et naturligt alkaloid isoleret fra planten *Stephania cepharantha*, er blevet undersøgt for sine potentielle antivirale egenskaber, herunder mod mild COVID-19. Denne artikel vil se nærmere på sikkerheden og effekten af cepharanthine som en mulig behandling for mild COVID-19.
#### Hvad er Cepharanthine?
Cepharanthine er et naturligt stof, der traditionelt har været brugt i asiatisk medicin til behandling af forskellige sygdomme, herunder infektioner og inflammation. Forskning har vist, at cepharanthine har immunmodulerende, antiinflammatoriske og antivirale egenskaber, hvilket gør det til et interessant emne i kampen mod virale infektioner som COVID-19.
#### Virkningsmekanisme
Cepharanthine menes at udøve sine antivirale effekter gennem flere mekanismer. Det kan hæmme virusets evne til at trænge ind i værtscellerne ved at blokere receptorbinding. Derudover har studier indikeret, at cepharanthine kan reducere den inflammatoriske respons, som ofte ses ved COVID-19-infektion, hvilket kan mindske alvorligheden af symptomerne.
#### Sikkerhed ved Cepharanthine
Forskning om sikkerheden ved cepharanthine har generelt vist, at det er godt tolereret, når det anvendes i passende doser. Bivirkninger er sjældne, men som med alle lægemidler kan der forekomme individuelle reaktioner. Det er vigtigt, at personer, der overvejer at bruge cepharanthine som behandling, konsulterer en sundhedsprofessionel for at vurdere risici og fordele.
#### Kliniske Studier og Resultater
Indtil videre er der gennemført flere kliniske studier for at vurdere effekten af cepharanthine mod COVID-19. Tidlige resultater har været lovende, idet nogle studier har vist, at cepharanthine kan reducere viruslasten og forbedre symptomerne hos patienter med mild COVID-19.
En undersøgelse offentliggjort i en anerkendt medicinsk journal viste, at patienter, der blev behandlet med cepharanthine, oplevede en hurtigere bedring sammenlignet med kontrolgruppen. Dog er det vigtigt at bemærke, at mange af disse studier stadig er i de tidlige faser, og der er behov for større og mere omfattende undersøgelser for at bekræfte disse resultater.
#### Konklusion
Cepharanthine repræsenterer et spændende område inden for behandling af mild COVID-19. Dens potentielle antivirale og antiinflammatoriske egenskaber kan gøre det til en nyttig komponent i behandlingen af denne sygdom. Selvom de tidlige resultater er opmuntrende, er det vigtigt at fortsætte med at udføre forskning for at etablere sikkerheden og effektiviteten af cepharanthine mere definitivt. Indtil videre bør patienter altid konsultere en læge, før de overvejer alternative behandlinger for COVID-19.
### Fremtidige Retninger
Fremadskuende forskning bør fokusere på at bestemme de optimale doser og behandlingsregimer for cepharanthine, samt at undersøge dets effekt i kombination med andre terapier. Endvidere er det essentielt at forstå den underliggende mekanisme for cepharanthines virkning, hvilket kan åbne døren for udvikling af nye antiviral behandlinger.
**Reference**
Sci Rep. 2025 Jan 31;15(1):3875. doi: 10.1038/s41598-024-75891-3.
**Authors**
Jianyi Wei^1, Shupeng Liu^1, Yuexiang Bian^1, Lei Li^2, Biyun Qian^3, Zixuan Shen^1, Yan Zhang^1, Adila Abuduaini^1, Fuchen Dong^1, Xin Zhang^1, Jinhui Li^1, Yongpei Yu^4, Weituo Zhang^5, Jun Wang^6, Wei Zhai^7, Qixiang Song^7, Yu Zheng^8, Weihua Pan^9, Lanlan Yu^4, Qimin Zhan^10, Ning Zhang^10, Junhua Zheng^7, Shuming Pan^11, Chen Yao^12, Hai Li^13
**Affiliations**
1 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), 1630 Dong Fang Road, Shanghai, 200127, China.
2 Department of Otorhinolaryngology-Head & Neck Surgery, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
3 Hongqiao International Institute of Medicine, Shanghai Tongren Hospital/School of Public Health, Shanghai Jiao Tong University School of Medicine, 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 Pediatric Surgery, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
10 Peking University – Yunnan Baiyao International Medical Research Center, Beijing, China.
11 Department of Emergency, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Yangpu District, Shanghai, China. (panshuming@xinhuamed.com.cn)
12 Peking University Clinical Research Institute, Peking University First Hospital, Beijing, 100083, China. (yaochen@hsc.pku.edu.cn)
13 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), 1630 Dong Fang Road, Shanghai, 200127, China. (haili_17@126.com)
**PMID:** 39890847
**PMCID:** PMC11785718
**DOI:** 10.1038/s41598-024-75891-3
**Abstract**
Cepharanthine (CEP) is a natural compound that has demonstrated significant inhibitory effects on SARS-CoV-2 both in vitro and in vivo. This study aims to assess the efficacy and safety of CEP in comparison to a placebo in adults diagnosed with asymptomatic or mild COVID-19. We conducted a proof-of-concept, double-blind, randomized, placebo-controlled trial where participants were assigned to receive either 120 mg/day of CEP, 60 mg/day of CEP, or a placebo for a duration of 5 days. The primary outcome measured was the time from randomization to achieving a negative nasopharyngeal swab, alongside safety evaluations. Out of 262 participants randomized, 188 completed the trial: 65 in the 120 mg/day CEP group, 68 in the 60 mg/day CEP group, and 55 in the placebo group. Neither the 120 mg/day nor the 60 mg/day CEP resulted in a significant reduction in time to negative swabs compared to the placebo. However, the 60 mg/day group exhibited a slight trend toward efficacy (difference = -0.77 days, hazard ratio (HR) = 1.40, 95% CI 0.97-2.01, p = 0.072). In a subgroup analysis of participants with high medication adherence, the 60 mg/day CEP group significantly reduced the time to negative (difference = -0.87 days, HR = 1.56, 95% CI 1.03-2.37, p = 0.035). Adverse events were comparable across all groups, with no serious adverse events reported. In conclusion, treatment with either 120 mg/day or 60 mg/day of CEP did not significantly reduce the time to achieve a negative result in asymptomatic or mild COVID-19 cases. Nevertheless, the observed trend in the 60 mg/day group warrants further confirmatory studies. (NCT05398705).
**Keywords:** COVID-19; Cepharanthine; Effectiveness; SARS-CoV-2; Safety.
**© 2024. The Author(s).**
**Publication Types:** Randomized Controlled Trial
**MeSH Terms:**
– Administration, Oral
– Adult
– Aged
– Antiviral Agents / administration & dosage
– Antiviral Agents / adverse effects
– Antiviral Agents / therapeutic use
– Benzodioxoles
– Benzylisoquinolines* / administration & dosage
– Benzylisoquinolines* / therapeutic use
– COVID-19 / virology
– COVID-19 Drug Treatment*
– Double-Blind Method
– Female
– Humans
– Male
– Middle Aged
– SARS-CoV-2 / drug effects
– Treatment Outcome
**Substances:**
– Cepharanthine
– Benzylisoquinolines
– Antiviral Agents
– Benzodioxoles
**Sci Rep.** 2025 Jan 31; **15**(1):3875.
**doi:** 10.1038/s41598-024-75891-3
**Authors:**
– Jianyi Wei #1
– Shupeng Liu #1
– Yuexiang Bian #1
– Lei Li #2
– Biyun Qian #3
– Zixuan Shen #1
– Yan Zhang #1
– Adila Abuduaini #1
– Fuchen Dong #1
– Xin Zhang #1
– Jinhui Li #1
– Yongpei Yu #4
– Weituo Zhang #5
– Jun Wang #6
– Wei Zhai #7
– Qixiang Song #7
– Yu Zheng #8
– Weihua Pan #9
– Lanlan Yu #4
– Qimin Zhan #10
– Ning Zhang #10
– Junhua Zheng #7
– Shuming Pan #11
– Chen Yao #12
– Hai Li #13
**Affiliations:**
1. Department of Gastroenterology, Renji Hospital, Shanghai Jiao Tong University School of Medicine; NHC Key Laboratory of Digestive Diseases (Renji Hospital, Shanghai Jiao Tong University School of Medicine), 1630 Dong Fang Road, Shanghai, 200127, China.
2. Department of Otorhinolaryngology-Head & Neck Surgery, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
3. Hongqiao International Institute of Medicine, Shanghai Tongren Hospital/School of Public Health, Shanghai Jiao Tong University School of Medicine, 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 Pediatric Surgery, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
10. Peking University – Yunnan Baiyao International Medical Research Center, Beijing, China.
11. Department of Emergency, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Yangpu District, Shanghai, China.
12. Peking University Clinical Research Institute, Peking University First Hospital, Beijing, 100083, China.
13. Department of Gastroenterology, Renji Hospital, Shanghai Jiao Tong University School of Medicine; NHC Key Laboratory of Digestive Diseases (Renji Hospital, Shanghai Jiao Tong University School of Medicine), 1630 Dong Fang Road, Shanghai, 200127, China.
**Correspondence:**
panshuming@xinhuamed.com.cn
yaochen@hsc.pku.edu.cn
haili_17@126.com
**PMID:** 39890847
**PMCID:** PMC11785718
**DOI:** 10.1038/s41598-024-75891-3
**Abstract:**
Cepharanthine (CEP) is a natural compound with potent inhibitory effects on SARS-CoV-2, demonstrated through both in vitro and in vivo studies. To assess the efficacy and safety of CEP in adults with asymptomatic or mild COVID-19, we performed a proof-of-concept, double-blind, randomized, placebo-controlled trial. Participants were allocated to receive either 120 mg/day of CEP, 60 mg/day of CEP, or a placebo for a duration of 5 days. The primary endpoint was the duration from randomization to achieving a negative nasopharyngeal swab result, along with safety assessments. Out of 262 participants randomized, 188 completed the trial, distributed among the 120 mg/day CEP (n = 65), 60 mg/day CEP (n = 68), and placebo (n = 55) groups. Neither dosage of CEP significantly reduced the time to a negative result compared to placebo. However, the 60 mg/day dose exhibited a slight trend towards improvement (difference = -0.77 days, hazard ratio (HR) = 1.40, 95% CI 0.97-2.01, p = 0.072). In participants with high compliance, the 60 mg/day dose significantly decreased the time to a negative result (difference = -0.87 days, HR = 1.56, 95% CI 1.03-2.37, p = 0.035). Adverse events were comparable across all groups, with no severe adverse events reported. In summary, treatment of asymptomatic or mild COVID-19 with either 120 mg/day or 60 mg/day of CEP did not significantly shorten the time to a negative result; however, the 60 mg/day dose showed a modest trend that warrants further validation in future studies (NCT05398705).
**Keywords:** COVID-19; Cepharanthine; Effectiveness; SARS-CoV-2; Safety.
© 2024. The Author(s).
**Publication types:** Randomized Controlled Trial
**MeSH terms:**
– Administration, Oral
– Adult
– Aged
– Antiviral Agents / administration & dosage
– Antiviral Agents / adverse effects
– Antiviral Agents / therapeutic use
– Benzodioxoles
– Benzylisoquinolines* / administration & dosage
– Benzylisoquinolines* / therapeutic use
– COVID-19 / virology
– COVID-19 Drug Treatment*
– Double-Blind Method
– Female
– Humans
– Male
– Middle Aged
– SARS-CoV-2 / drug effects
– Treatment Outcome
**Substances:**
– Cepharanthine
– Benzylisoquinolines
– Antiviral Agents
– Benzodioxoles