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Recent:   

Efficacy and safety of GST-HG171 in adult patients with mild to moderate COVID-19: a randomised, double-blind, placebo-controlled phase 2/3 trial

Lu et al., eClinicalMedicine, doi:10.1016/j.eclinm.2024.102582, NCT05656443
May 2024  
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0 0.5 1 1.5 2+ Time to sustained recovery 13% Improvement Relative Risk Time to negative conversion 25% GST-HG171  Lu et al.  EARLY TREATMENT  DB RCT Is early treatment with GST-HG171 beneficial for COVID-19? Double-blind RCT 1,217 patients in China (December 2022 - May 2023) Faster recovery (p=0.033) and viral clearance (p<0.0001) c19early.org Lu et al., eClinicalMedicine, May 2024 Favors GST-HG171 Favors control
RCT 1,213 outpatients with mild-to-moderate COVID-19 in China showing a shorter time to sustained recovery and faster viral clearance with GST-HG171 plus ritonavir.
time to sustained recovery, 12.8% lower, HR 0.87, p = 0.03, treatment 610, control 603, inverted to make HR<1 favor treatment.
time to negative conversion, 24.7% lower, HR 0.75, p < 0.001, treatment 610, control 607, inverted to make HR<1 favor treatment.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Lu et al., 31 May 2024, Double Blind Randomized Controlled Trial, placebo-controlled, China, peer-reviewed, mean age 34.5, 37 authors, study period 19 December, 2022 - 4 May, 2023, trial NCT05656443 (history). Contact: nanshan@vip.163.com, luhongzhou@fudan.edu.cn, george.zhang@akeylink.cn, chenxc998@fjmu.edu.cn, zhan071119@163.com, linl6@163.com, tangyanan@cosunter.com, lin_fenghn@126.com, hnldzfy@126.com, 553039465@qq.com, yi_ming@126.com, kaiyu@jlu.edu.cn, 413699442@qq.com, 490458234@qq.com, hly0311@sina.com, hp_cq@163.com, yhlin_xm@163.com, zxbqz@163.com, connie.chen@tigermedgrp.com, yanwenhao@akeylink.cn, yanxiuping@akeylink.cn, mu@tigermedgrp.com, ella.lin@tigermedgrp.com, tuxinyu1997@gmail.com, tanhongshan@akeylink.cn, huzhiqiang@cosunter.com, lihongming@cosunter.com, lgp@cosunter.com, jeffyah@163.com, chen_xinwen@gzlab.ac.cn, fswang302@163.com.
This PaperMiscellaneousAll
Efficacy and safety of GST-HG171 in adult patients with mild to moderate COVID-19: a randomised, double-blind, placebo-controlled phase 2/3 trial
Hongzhou Lu, George Zhang, John Mao, Xiaochun Chen, Yangqing Zhan, Ling Lin, Tianxiang Zhang, Yanan Tang, Feng Lin, Feiyue Zhu, Yuanlong Lin, Yiming Zeng, Kaiyu Zhang, Wenfang Yuan, Zhenyu Liang, Ruilin Sun, Liya Huo, Peng Hu, Yihua Lin, Xibin Zhuang, Zhaohui Wei, Xia Chen, Wenhao Yan, Xiuping Yan, Lisa Mu, Zhuhua Lin, Xinyu Tu, Hongshan Tan, Fuhu Huang, Zhiqiang Hu, Hongming Li, Guoping Li, Haijun Fu, Zifeng Yang, Xinwen Chen, Fu-Sheng Wang, Nanshan Zhong
eClinicalMedicine, doi:10.1016/j.eclinm.2024.102582
Background GST-HG171 is a potent, broad-spectrum, orally bioavailable small-molecule 3C like protease inhibitor that has demonstrated greater potency and efficacy compared to Nirmatrelvir in pre-clinical studies. We aimed to evaluate the efficacy and safety of orally administered GST-HG171 plus Ritonavir in patients with coronavirus disease 2019 (COVID-19) infected with emerging XBB and non-XBB variants. Methods This randomised, double-blind, placebo-controlled phase 2/3 trial was conducted in 47 sites in China among adult patients with mild-to-moderate COVID-19 with symptoms onset ≤72 h. Eligible patients were randomised 1:1 to receive GST-HG171 (150 mg) plus Ritonavir (100 mg) or corresponding placebo tablets twice daily for 5 days, with stratification factors including the risk level of disease progression and vaccination status. The primary efficacy endpoint was time to sustained recovery of clinical symptoms within 28 days, defined as a score of 0 for 11
Contributors NZ, HongzL, GZ, JM, YZ, XiaC, ZY, XinC, GW, and XiaoC conceived and designed the study. NZ and HongzL are co-principal investigators, and FL, LL, FZ, YL, YZ, KZ, WenfY, RS, LH, PH, YL, XZ, and FW are investigators. YT, TZ, WenhY, XY, HT, LM, FH, ZH, and ZY executed the study, with supervision from GZ, JM, YZ, ZY, ZheL, HongmL, and GL. ZW, ZhuL, and HF contributed to statistical analysis. GZ, XiaC, and XT drafted the manuscript, with critical revision by NZ, HongzL, JM, YZ, TZ, XY, ZhuL, GW, XiaoC, XinC, and FW. NZ, HongzL, and GZ have directly accessed and verified the underlying data reported in the manuscript. All authors had full access to all the data in the study, and approved of this manuscript to be submitted for publication. Data sharing statement After approval from the Human Genetic Resources Administration of China, this trial data can be shared with qualifying researchers who submit a proposal with a valuable research question. A contract should be signed. Declaration of interests
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