Study of Oral High/Low-dose Cepharanthine Compared With Placebo in Non Hospitalized Adults With COVID-19

Summary

The purpose of this study is to evaluate the efficacy and safety of high/low-dose cepharanthine for the Treatment of COVID-19 in asymptomatic and non-pneumonia mild adult participants with COVID-19 who do not need to be in the hospital, but in alternate care site.

Timeline

Start

2022-05-31

Primary completion

2022-08-10

Completion

2022-08-10

Outcome

Missed primary endpoint

paper Neither 120 mg/day or 60 mg/day CEP shortened the time to negative significantly compared with placebo. PMID 39890847 ↗

Publications

• Results Shen Y, Ai J, Lin N, Zhang H, Li Y, Wang H, Wang S, Wang Z, Li T, Sun F, Fan Z, Li L, Lu Y, Meng X, Xiao H, Hu H, Ling Y, Li F, Li H, Xi C, Gu L, Zhang W, Fan X. An open, prospective cohort study of VV116 in Chinese participants infected with SARS-CoV-2 omicron variants. Emerg Microbes Infect. 2022 Dec;11(1):1518-1523. doi: 10.1080/22221751.2022.2078230.
• Results Hammond J, Leister-Tebbe H, Gardner A, Abreu P, Bao W, Wisemandle W, Baniecki M, Hendrick VM, Damle B, Simon-Campos A, Pypstra R, Rusnak JM; EPIC-HR Investigators. Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19. N Engl J Med. 2022 Apr 14;386(15):1397-1408. doi: 10.1056/NEJMoa2118542. Epub 2022 Feb 16.
• 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. 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. Sci Rep. 2025 Jan 31;15(1):3875. doi: 10.1038/s41598-024-75891-3.

Drugs

Indications