Oral Simnotrelvir for Adult Patients with Mild-to-Moderate Covid-19
文献类型：期刊论文
| 作者 | Cao, Bin2,27,29; Wang, Yeming29; Lu, Hongzhou23; Huang, Chaolin22; Yang, Yumei26; Shang, Lianhan29; Chen, Zhu20; Jiang, Rongmeng25; Liu, Yihe19; Lin, Ling18 |
| 刊名 | NEW ENGLAND JOURNAL OF MEDICINE
 |
| 出版日期 | 2024-01-18 |
| 卷号 | 390期号:3页码:230-241 |
| ISSN号 | 0028-4793 |
| DOI | 10.1056/NEJMoa2301425 |
| 通讯作者 | Cao, Bin(caobin_ben@163.com) ; Tang, Renhong(renhong.tang@simceregroup.com) ; Wang, Chen(cyh-birm@263.net) |
| 英文摘要 | BACKGROUND Simnotrelvir is an oral 3-chymotrypsin-like protease inhibitor that has been found to have in vitro activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and potential efficacy in a phase 1B trial. METHODS In this phase 2-3, double-blind, randomized, placebo-controlled trial, we assigned patients who had mild-to-moderate coronavirus disease 2019 (Covid-19) and onset of symptoms within the past 3 days in a 1:1 ratio to receive 750 mg of simnotrelvir plus 100 mg of ritonavir or placebo twice daily for 5 days. The primary efficacy end point was the time to sustained resolution of symptoms, defined as the absence of 11 Covid-19-related symptoms for 2 consecutive days. Safety and changes in viral load were also assessed. RESULTS A total of 1208 patients were enrolled at 35 sites in China; 603 were assigned to receive simnotrelvir and 605 to receive placebo. Among patients in the modified intention-to-treat population who received the first dose of trial drug or placebo within 72 hours after symptom onset, the time to sustained resolution of Covid-19 symptoms was significantly shorter in the simnotrelvir group than in the placebo group (180.1 hours [95% confidence interval {CI}, 162.1 to 201.6] vs. 216.0 hours [95% CI, 203.4 to 228.1]; median difference, -35.8 hours [95% CI, -60.1 to -12.4]; P=0.006 by Peto-Prentice test). On day 5, the decrease in viral load from baseline was greater in the simnotrelvir group than in the placebo group (mean difference [+/- SE], -1.510.14 log(10) copies per milliliter; 95% CI, -1.79 to -1.24). The incidence of adverse events during treatment was higher in the simnotrelvir group than in the placebo group (29.0% vs. 21.6%). Most adverse events were mild or moderate. CONCLUSIONS Early administration of simnotrelvir plus ritonavir shortened the time to the resolution of symptoms among adult patients with Covid-19, without evident safety concerns. |
| 资助项目 | Jiangsu Simcere Pharmaceutical |
| WOS研究方向 | General & Internal Medicine |
| 语种 | 英语 |
| WOS记录号 | WOS:001190252500001 |
| 出版者 | MASSACHUSETTS MEDICAL SOC |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/310568]  |
| 专题 | 新药研究国家重点实验室 |
| 通讯作者 | Cao, Bin; Tang, Renhong; Wang, Chen |
| 作者单位 | 1.Bldg 23,699-18 Xuanwu Ave, Nanjing, Peoples R China 2.Japan Friendship Hosp, 2 E Yinghua Rd, Beijing 100029, Peoples R China 3.Cent Peoples Hosp Zhanjiang, Zhanjiang, Peoples R China 4.Xuzhou Infect Dis Hosp, Xuzhou, Jiangsu, Peoples R China 5.Shandong Publ Hlth Clin Ctr, Second Dept Infect, Jinan, Peoples R China 6.Guizhou Prov Peoples Hosp, Guiyang, Peoples R China 7.First Affiliated Hosp Xiamen Univ, Xiamen, Peoples R China 8.State Key Lab Neurol & Oncol Drug Dev, Nanjing, Peoples R China 9.Jiangsu Simcere Pharmaceut, Nanjing, Jiangsu, Peoples R China 10.Second Hosp Nanjing, Nanjing, Peoples R China |
| 推荐引用方式 GB/T 7714 | Cao, Bin,Wang, Yeming,Lu, Hongzhou,et al. Oral Simnotrelvir for Adult Patients with Mild-to-Moderate Covid-19[J]. NEW ENGLAND JOURNAL OF MEDICINE,2024,390(3):230-241. |
| APA | Cao, Bin.,Wang, Yeming.,Lu, Hongzhou.,Huang, Chaolin.,Yang, Yumei.,...&Wang, Chen.(2024).Oral Simnotrelvir for Adult Patients with Mild-to-Moderate Covid-19.NEW ENGLAND JOURNAL OF MEDICINE,390(3),230-241. |
| MLA | Cao, Bin,et al."Oral Simnotrelvir for Adult Patients with Mild-to-Moderate Covid-19".NEW ENGLAND JOURNAL OF MEDICINE 390.3(2024):230-241. |
入库方式： OAI收割
来源：上海药物研究所
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