Leritrelvir for the treatment of mild or moderate COVID-19 without co-administered ritonavir: a multicentre randomised, double-blind, placebo-controlled phase 3 trial
Yangqing Zhan, Zhengshi Lin, Jingyi Liang, Ruilin Sun, Yueping Li, Bingliang Lin, Fangqi Ge, Ling Lin, Hongzhou Lu, Liang Su, Tianxin Xiang, Hongqiu Pan, Chaolin Huang, Ying Deng, Furong Wang, Ruhong Xu, Dexiong Chen, Ping Zhang, Jianlin Tong, Xifu Wang, Qingwei Meng, Zhigang Zheng, Shuqiang Ou, Xiaoyun Guo, Herui Yao, Tao Yu, Weiyang Li, Yu Zhang, Mei Jiang, Zhonghao Fang, Yudi Song, Ruifeng Chen, Jincan Luo, Changyuan Kang, Shiwei Liang, Haijun Li, Jingping Zheng, Nanshan Zhong, Zifeng Yang, Huang Yanming, Dong Haiping, Jinlin Hou, Shao Lei, Li Xiaoguang, Gao Yan
eClinicalMedicine, doi:10.1016/j.eclinm.2023.102359
Background Leritrelvir is a novel α-ketoamide based peptidomimetic inhibitor of SARS-CoV-2 main protease. A preclinical study has demonstrated leritrelvir poses similar antiviral activities towards different SARS-CoV-2 variants compared with nirmatrelvir. A phase 2 clinical trial has shown a comparable antiviral efficacy and safety between leritrelvir with and without ritonavir co-administration. This trial aims to test efficacy and safety of leritrelvir monotherapy in adults with mild-to-moderate COVID-19.
Contributors Conceived study: Nanshan Zhong, Jingping Zheng, Zifeng Yang, Designed study and experiments: Yangqing Zhan, Zifeng Yang, Nanshan Zhong. Performed experiments: Yangqing Zhan, Nanshan Zhong, Jingping Zheng, Yueping Li, Hongzhou Lu, Ling Lin, Liang Su, Tianxin Xiang, Hongqiu Pan, Chaolin Huang, Ying Deng, Furong Wang, Ruhong Xu, Bingliang Lin, Ruilin Sun, Fangqi Ge, Dexiong Chen, Ping Zhang, Jianlin Tong, Xifu Wang, Qingwei Meng, Zhigang Zheng, Shuqiang Ou, Xiaoyun Guo, Herui Yao, Tao Yu, Weiyang Li, Yu Zhang. Interpreted data: Zhengshi Lin, Nanshan Zhong, Yangqing Zhan, Jingyi Liang, Zhonghao Fang, Shiwei Liang, Haijun Li. Manuscript preparation: Zhengshi Lin, Chuanmeizi Tu, Qianying Li, Zifeng Yang, Nanshan Zhong, Ruifeng Chen, Jingyi Liang, Zhonghao Fang, Jincan Luo, Yudi Song, Changyuan Kang, Mei Jiang. Jingyi Liang, Zhonghao Fang, Shiwiei Liang, Zhengshi Lin have accessed and verified the data, and Zifeng Yang, Jingping Zheng, Nanshan Zhong were responsible for the decision to submit the manuscript.
Data sharing statement After approval from Human Genetic Resource Adminstration of China and Guangdong Raynovent Biotech Co., Ltd., this trial data can be shared with qualifying researchers who submit a valuable research question.
Declaration of interests No potential conflicts of interest were reported by the authors.
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