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Efficacy and safety of SIM0417 (SSD8432) plus ritonavir for COVID-19 treatment: a randomised, double-blind, placebo- controlled, phase 1b trial

文献类型：期刊论文

作者Wang, Fuxiang1; Xiao, Wen1; Tang, Yimin1; Cao, Mengli1; Shu, Dan1; Asakawa, Tetsuya2; Xu, Yechun3; Jiang, Xiangrui3; Zhang, Leike4; Wang, Wei5
刊名LANCET REGIONAL HEALTH-WESTERN PACIFIC
出版日期2023-09-01
卷号38页码:13
关键词Covid-19 3CL protease inhibitor SARS-CoV-2 viral load Alleviation of COVID-19 symptoms
DOI10.1016/j.lanwpc.2023.100835
通讯作者Tang, Renhong(renhong.tang@simceregroup.com) ; Shen, Jingshan(shenjingshan@simm.ac.cn) ; Lu, Hongzhou(luhongzhou@fudan.edu.cn)
英文摘要Background SIM0417 (SSD8432) is an orally administered coronavirus main proteinase (3CLpro) inhibitor with po-tential anti-SARS-CoV-2 activity. This study aimed to evaluate the efficacy , safety of SIM0417 plus ritonavir (a pharmacokinetic enhancer) in adults with COVID-19.Methods This was a randomised, double-blind, placebo-controlled, phase 1b study in China. Adults with asymptomatic infection, mild or moderate COVID-19 were randomly assigned (3:3:2) to receive either 750 mg SIM0417 plus 100 mg ritonavir, 300 mg SIM0417 plus 100 mg ritonavir or placebo every 12 h for 10 doses. The main efficacy endpoints included SARS-CoV-2 viral load, proportion of participants with positive SARS-CoV-2 nucleic acid test and time to alleviation of COVID-19 symptoms. This trial is registered with ClinicalTrials.gov, NCT05369676.Findings Between May 12 and August 29, 2022, 32 participants were enrolled and randomised to high dose group (n = 12), low dose group (n = 12) or placebo (n = 8). The viral load change from baseline in high dose group was statistically lower compared with placebo, with a maximum mean difference of -2.16 & PLUSMN; 0.761 log10 copies/mL (p = 0.0124) on Day 4. The proportion of positive SARS-CoV-2 in both active groups were lower than the placebo. The median time to sustained alleviation of COVID-19 symptoms was 2.0 days in high dose group versus 6.0 days in the placebo group (HR = 3.08, 95% CI 0.968-9.818). SIM0417 plus ritonavir were well tolerated with all adverse events in grade 1.Interpretation SIM0417 plus ritonavir was generally well tolerated. The efficacy of SIM0417 showed a monotonic dose-response relationship , the 750 mg SIM0417 plus 100 mg ritonavir was selected as the recommended clinical dose.
资助项目Jiangsu Simcere Pharmaceutical Co., Ltd.
WOS研究方向Health Care Sciences & Services ; Public, Environmental & Occupational Health
语种英语
出版者ELSEVIER
WOS记录号WOS:001058103800001
源URL[http://119.78.100.183/handle/2S10ELR8/307055]  
专题新药研究国家重点实验室
通讯作者Tang, Renhong; Shen, Jingshan; Lu, Hongzhou
作者单位1.Third Peoples Hosp Shenzhen, Natl Clin Res Ctr Infect Dis, Dept Infect Dis, Shenzhen, Peoples R China
2.Third Peoples Hosp Shenzhen, Inst Neurol, Natl Clin Res Ctr Infect Dis, Shenzhen, Peoples R China
3.Chinese Acad Sci, State Key Lab Drug Res, Shanghai Inst Mat Med, Shanghai, Peoples R China
4.Chinese Acad Sci, Wuhan Inst Virol, Wuhan, Peoples R China
5.Jiangsu Simcere Pharmaceut Co Ltd, Nanjing, Peoples R China
6.State Key Lab Neurol & Oncol Drug Dev, Nanjing, Peoples R China
推荐引用方式
GB/T 7714		 Wang, Fuxiang,Xiao, Wen,Tang, Yimin,et al. Efficacy and safety of SIM0417 (SSD8432) plus ritonavir for COVID-19 treatment: a randomised, double-blind, placebo- controlled, phase 1b trial[J]. LANCET REGIONAL HEALTH-WESTERN PACIFIC,2023,38:13.
APA Wang, Fuxiang.,Xiao, Wen.,Tang, Yimin.,Cao, Mengli.,Shu, Dan.,...&Lu, Hongzhou.(2023).Efficacy and safety of SIM0417 (SSD8432) plus ritonavir for COVID-19 treatment: a randomised, double-blind, placebo- controlled, phase 1b trial.LANCET REGIONAL HEALTH-WESTERN PACIFIC,38,13.
MLA Wang, Fuxiang,et al."Efficacy and safety of SIM0417 (SSD8432) plus ritonavir for COVID-19 treatment: a randomised, double-blind, placebo- controlled, phase 1b trial".LANCET REGIONAL HEALTH-WESTERN PACIFIC 38(2023):13.

入库方式： OAI收割

来源：上海药物研究所

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