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All Studies   Meta Analysis    Recent:   

Leritrelvir for the treatment of mild or moderate COVID-19 without co-administered ritonavir: a multicentre randomised, double-blind, placebo-controlled phase 3 trial

Zhan et al., eClinicalMedicine, doi:10.1016/j.eclinm.2023.102359, NCT05620160
Jan 2024  
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Sustained clinical recovery 17% Improvement Relative Risk Sustained clinical remission 14% Clinical recovery 21% Clinical remission 22% Viral clearance 16% Leritrelvir  Zhan et al.  EARLY TREATMENT  DB RCT Is early treatment with leritrelvir beneficial for COVID-19? Double-blind RCT 1,359 patients in China (November - December 2022) Improved recovery (p=0.0022) and viral clearance (p=0.014) c19early.org Zhan et al., eClinicalMedicine, January 2024 Favorsleritrelvir Favorscontrol 0 0.5 1 1.5 2+
RCT 1,359 COVID-19 outpatients showing faster recovery with leritrelvir monotherapy (without ritonavir), 251 vs. 271 hours, and improved viral clearance. There were no significant differences in adverse events between groups.
sustained clinical recovery, 16.7% lower, HR 0.83, p = 0.002, treatment 680, control 679, inverted to make HR<1 favor treatment.
sustained clinical remission, 13.8% lower, HR 0.86, p = 0.01, treatment 680, control 679, inverted to make HR<1 favor treatment.
clinical recovery, 21.4% lower, RR 0.79, p = 0.04, treatment 111 of 680 (16.3%), control 141 of 679 (20.8%), NNT 23, day 28.
clinical remission, 22.0% lower, RR 0.78, p = 0.06, treatment 89 of 680 (13.1%), control 114 of 679 (16.8%), NNT 27, day 28.
risk of no viral clearance, 16.1% lower, RR 0.84, p = 0.01, treatment 231 of 680 (34.0%), control 275 of 679 (40.5%), NNT 15, day 15.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Zhan et al., 31 Jan 2024, Double Blind Randomized Controlled Trial, placebo-controlled, China, peer-reviewed, 45 authors, study period 12 November, 2022 - 30 December, 2022, trial NCT05620160 (history). Contact: jeffyah@163.com, nanshan@vip.163.com, jpzhenggy@163.com.
This PaperLeritrelvirAll
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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Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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