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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