A Randomized, Double-blinded, Placebo-controlled, Parallel-treatment Group, Adaptive Design, Multi-center, Phase 2b/3 Trial to Evaluate Efficacy and Safety of NuSepin® Intravenous Infusion in COVID-19 Pneumonia Patients

开始日期2022-09-05

申办/合作机构

Shaperon, Inc.

NCT05352347 / Recruiting临床2/3期

开始日期2022-04-12

申办/合作机构

Shaperon, Inc.

NCT04565379 / Completed临床2期

A Randomized, Double Blind, Placebo-controlled, Phase 2 Clinical Trial to Investigate the Efficacy and Safety of 2 Doses of NuSepin® Intravenous Infusion in COVID-19 Pneumonia Patients

A randomized, double blind, placebo-controlled, phase 2 clinical trial to investigate the efficacy and safety of 2 doses of NuSepin® intravenous infusion in COVID-19 pneumonia patients

开始日期2020-09-24

申办/合作机构

Shaperon, Inc.

100 项与 NuSepin 相关的临床结果

登录后查看更多信息

100 项与 NuSepin 相关的转化医学

登录后查看更多信息

100 项与 NuSepin 相关的专利（医药）

登录后查看更多信息

项与 NuSepin 相关的文献（医药）

Scientific Reports

Effects of intravenous inflammasome inhibitor (NuSepin) on suppression of proinflammatory cytokines release induced by cardiopulmonary bypass in swine model: a pilot study

Article

作者: Yoon, Seung Zhoo ; Lee, Jeonghoon ; Jung, Jae Seung ; Lee, Seung Hyong ; Kim, Eung Hwi ; Kim, Ji Eon ; Park, Jeong Jun

AbstractThe systemic inflammatory response syndrome can occur due to an inflammatory reaction to the release of cytokines, and it has been linked to the circulation of pro- and anti-inflammatory cytokines. The cardiopulmonary bypass (CPB) system is known to activate numerous inflammatory pathways. Applying CPB in large animals for an extended period may be useful as a controlled experimental model for systemic inflammatory responses. The authors hypothesized that 0.2 mg/kg NuSepin® would inhibit CBP-induced proinflammatory cytokine release, and attenuate CPB-induced vasoplegia. CPB was maintained for 2 h in 8 male Yorkshire pigs. Ten ml of saline was administered intravenously to the control group, while the study group received 10 ml of NuSepin® (0.2 mg/kg), before start of CPB. Blood samples were collected at four different time points to evaluating the level of cytokine (TNF-α, IL-1β, IL-6, IL-8) release during and after CBP. All vital signals were recorded as continuous waveforms using the vital recorder®. Our study demonstrated that IL-6 increased in both groups during CPB remained unchanged. However, in the Nusepin group, IL-6 levels rapidly decreased when CPB was stopped and the proinflammatory reaction subsided. Furthermore, the dose of norepinephrine required to maintain a mean pressure of 60 mmHg was also lower in the Nusepin group.

100 项与 NuSepin 相关的药物交易

登录后查看更多信息