预约演示
更新于：2025-03-29
Romlusevimab
罗米司韦单抗
更新于：2025-03-29
概要
基本信息
药物类型 单克隆抗体 |
别名 BRII-198、BRII198 |
作用方式 抑制剂 |
作用机制 SARS-CoV-2 S protein抑制剂(冠状病毒刺突糖蛋白抑制剂) |
在研适应症 |
非在研适应症- |
原研机构 |
在研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (2021-12-08), |
最高研发阶段(中国)批准上市 |
特殊审评附条件批准 (中国) |
登录后查看时间轴
结构/序列
Sequence Code 651435872H
来源: *****
Sequence Code 651435873L
来源: *****
关联
7
项与 罗米司韦单抗 相关的临床试验NCT04787211
A Phase 2 Study to Evaluate the Safety and Efficacy of Human Monoclonal Antibodies, BRII-196 and BRII-198, Administered by Intravenous Infusion for the Treatment of COVID-19 Patients
NCT04770467
A Phase 2, Randomized, Single-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of Human Monoclonal Antibodies, BRII-196 and BRII-198, Administered by Intravenous Infusion for the Treatment of COVID-19 Patients
NCT04691180
A Phase 1 Randomized, Single-blind, Placebo-controlled, Single Ascending Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Human Monoclonal Antibodies, Brii-196 and BRII-198, Administered Intravenously to Healthy Adult Volunteers
100 项与 罗米司韦单抗 相关的临床结果
登录后查看更多信息
100 项与 罗米司韦单抗 相关的转化医学
登录后查看更多信息
100 项与 罗米司韦单抗 相关的专利（医药）
登录后查看更多信息
22
项与 罗米司韦单抗 相关的文献（医药）2025-03-01JOURNAL OF INFECTION
The effect of amubarvimab-romlusevimab on clinical outcomes in patients with COVID-19: A meta-analysis
Letter
作者: Luo, Jie ; Chen, Min ; Balzer, Nathan ; Li, Toni ; Ao, Guangyu ; Wang, Yushu
2025-02-01CLINICAL MICROBIOLOGY AND INFECTION
Long-term outcomes of passive immunotherapy for COVID-19: a pooled analysis of a large multinational platform randomized clinical trial
Article
作者: Engen, Nicole ; Mena Lora, Alfredo J ; Self, Wesley H ; Williamson, John C ; Price, D Ashley ; Mathews, Gail ; Lundgren, Jens ; Murray, Thomas A ; Kitonsa, Jonathan ; Knox, Daniel B ; Mylonakis, Eleftherios ; Kim, Kami ; Reilly, Cavan ; Young, Barnaby Edward ; Siegel, Lianne K ; Sandkovsky, Uriel ; Jain, Mamta K ; Paredes, Roger ; Ramachandruni, Srikanth ; Holland, Thomas L ; Eriobu, Nnakelu ; Ginde, Adit ; Grandits, Gregory A ; Jensen, Tomas O ; Barkauskas, Christina ; Mourad, Ahmad ; Malin, Jakob J ; Vock, David ; Rapti, Vasiliki ; Higgs, Elizabeth
OBJECTIVES:
Passive immunotherapy, including monoclonal antibodies and neutralizing proteins, was used for the treatment of patients with COVID-19 during the pandemic. Accelerating COVID-19 Therapeutic Interventions and Vaccines-Therapeutics for Inpatients with COVID-19 (ACTIV-3/TICO) was a multinational, randomized placebo-controlled platform trial that evaluated the effectiveness of multiple passive immunotherapy agents in patients hospitalized with COVID-19. Given the long half-life of some agents studied, participants were followed for an extended period to assess the long-term efficacy and sustained safety of these agents.
METHODS:
We conducted a pooled analysis of individual participant data from four trials of ACTIV-3/TICO: sotrovimab, amubarvimab-romlusevimab, tixagevimab-cilgavimab, and ensovibep. Cox proportional hazards models were conducted to compare time to mortality and time to mortality or rehospitalization between participants receiving active agents vs. placebo through 18 months.
RESULTS:
A total of 2311 participants were enrolled between 16 December 2020 and 15 November 2021. Overall, 56.9% (1315/2311) received an active agent and 77.2% (1784/2311) of participants were unvaccinated for SARS-CoV-2. Median duration between symptom onset and enrolment was 8 days (interquartile range, 6-10), and most participants received remdesivir (92.1% [2129/2311]) and corticosteroids (70.4% [1627/2311]) before enrolment. There was no difference in mortality across all active (11.9% [157/1315]) vs. placebo (14.0% [139/996]) arms (hazard ratio, 0.87; 95% CI, 0.70-1.08). Furthermore, there was no difference in combined mortality or rehospitalization across all active (31.7% [417/1315]) vs. placebo (32.1% [320/996]) arms (hazard ratio, 0.96; 95% CI, 0.84-1.10).
DISCUSSION:
In our large study of long half-life passive immunotherapy for hospitalized patients with COVID-19, we did not find evidence of a long-term effect on either mortality or rehospitalization.
TRIAL REGISTRATION:
NCT04501978.
2024-12-01NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY
Sotrovimab in the treatment of coronavirus disease-2019 (COVID-19): a systematic review and meta-analysis of randomized clinical trials
Review
作者: Sobalvarro, Joselin Valeska Martinez ; Dos Reis, Tiago Marques ; Torres, Larissa Helena ; da Silva Amorim, Ana Flávia
This study was carried out to verify the evidence regarding the effectiveness and safety of sotrovimab in patients with COVID-19. This is a systematic review of randomized clinical trials retrieved from the PubMed, Embase, Scopus, Lilacs, and Cochrane Library databases. The risk of bias was measured using the Cochrane Risk and Bias Checklist (RoB 2). For the meta-analysis, RStudio Version 2024.04.2 software was used. The certainty of evidence was assessed using GRADE. The study protocol was registered in PROSPERO (CRD42022355786). A total of 1893 studies were identified and four were included in the study. The total population consisted of 5470 patients with COVID-19, 1921 (35%) in the sotrovimab group and 3549 (65%) in the control group (placebo or BRII-196 + BRII-198 or casirivimab + imdevimab or bamlanivimab + etesevimab, administered in a similar way to sotrovimab, in a single dose with a 60-min intravenous infusion). For the effectiveness outcome, three studies presented low risk and one high risk of bias, while for safety all presented high risk of bias. The meta-analysis showed no significant difference between the sotrovimab and control groups in terms of hospitalization rates (95% confidence interval (CI) - 2.10-0.51; p = 0 > 0.05), use of invasive mechanical ventilation (95% CI - 2.78-0.65; p = 0.35) and mortality (95% CI - 0.92-0.59; p = 0.39). However, sensitivity analysis showed that sotrovimab may be effective in reducing hospitalization rates compared to the control (IV = - 1.57; 95% CI - 2.41-0.73; p = 0.99). The use of sotrovimab in the treatment of patients with COVID-19 had no significant impact on mortality and need for mechanical ventilation and did not appear to be safer compared to controls. However, there was evidence of effectiveness in reducing the rate of hospitalization, although the certainty of the evidence is moderate and the risk of bias is high.
100 项与 罗米司韦单抗 相关的药物交易
登录后查看更多信息
研发状态
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 新型冠状病毒感染 | 中国 | 2021-12-08 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 353 | (BRII-196/BRII-198 Plus SOC) | 製壓簾餘鹽窪窪鏇淵顧 = 淵壓觸築範願願網醖蓋 鏇簾製觸艱顧衊蓋廠鬱 (憲餘壓夢衊獵遞鑰選艱, 艱衊築簾糧壓鏇構襯願 ~ 顧鑰網衊衊積網襯築構) 更多 | - | 2024-02-05 | ||
Placebo+Remdesivir (Placebo Plus SOC) | 製壓簾餘鹽窪窪鏇淵顧 = 選憲觸築膚夢窪積膚餘 鏇簾製觸艱顧衊蓋廠鬱 (憲餘壓夢衊獵遞鑰選艱, 獵構夢廠願網膚窪獵積 ~ 衊願醖鬱壓積製鬱繭蓋) 更多 | ||||||
临床1期 | 44 | 簾構鏇鏇艱窪糧積鑰壓(願繭淵構築鏇壓廠憲壓) = All infusions were well-tolerated without systemic or local infusion reactions, dose-limiting AEs, serious AEs, or deaths. 鏇鬱鏇壓廠廠糧艱範積 (繭糧範繭廠窪淵簾顧憲 ) 更多 | 积极 | 2022-09-06 | |||
临床3期 | 837 | 簾壓糧願廠製遞餘淵鏇(觸齋蓋積範蓋餘齋顧構) = 廠膚壓範顧繭壓襯鹽蓋 齋簾範鏇獵糧築襯憲壓 (簾構網廠繭齋鏇鹽蓋鏇 ) 更多 | 积极 | 2021-08-24 | |||
Placebo | 廠夢淵膚構憲積鑰衊構(窪廠襯鏇夢網積鏇蓋醖) = 鏇淵鹽遞醖憲簾廠衊顧 襯鹽醖遞積築膚鬱顧觸 (艱淵蓋製鏇壓鹽窪餘艱 ) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
来和芽仔聊天吧
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用