吸入IBIO123对轻度至中度COVID-19的安全性和有效性:一个随机,双盲,剂量上升,安慰剂控制的1/2期试验
Bruno Maranda1, Sébastien M Labbé1, Magali Lurquin1
1Immune Biosolutions, Sherbrooke, QC, Canada.
The Lancet. Infectious diseases
|August 24, 2023
概括
吸入IBIO123是一种针对COVID-19的新型抗体治疗方法,证明了安全性并改善了呼吸系统症状的解决. 支持进一步研究呼吸道疾病的吸入单克隆抗体.
科学领域:
- 免疫学 免疫学 免疫学
- 病毒学 病毒学
- 肺部病理学 肺部病理学
背景情况:
- COVID-19的严重程度与呼吸系统问题有关.
- 系统中和抗体显示有效性,但吸入输送可能提供直接的呼吸道益处.
- IBIO123是一种由三种完全人类中和单克隆抗体对抗SARS-CoV-2的新型尾酒.
研究的目的:
- 在轻度至中度COVID-19患者中评估吸入IBIO123的安全性和有效性.
- 评估吸入IBIO123对病毒载量和症状缓解的影响.
- 通过不良事件监测来确定吸入IBIO123的安全性.
主要方法:
- 在南非和巴西进行了一项双盲,剂量上升,安慰剂控制,首次在人体上进行的1/2期试验.
- 患有轻度至中度COVID-19的参与者接受了单剂量安慰剂或IBIO123 (1毫克,5毫克或10毫克在第一阶段;10毫克在第二阶段).
- 主要结局包括安全性 (第一阶段) 和SARS-CoV-2病毒载量的变化 (第二阶段);次要结局评估了症状缓解和疾病进展.
主要成果:
- 在第一阶段,没有发现安全问题. 在第二阶段,IBIO123在第五天没有显著降低病毒载量 (p=0.45).
- 在接受IBIO123的参与者中,更高比例的参与者在第6天出现了呼吸道症状的消失 (42%对17%,p=0.017).
- 在IBIO123组中没有发生死亡或住院,而在安慰剂组中发生了一例死亡和一例住院. 不良事件发生率在各组之间相似 (38%).
结论:
- 吸入IBIO123对于治疗轻度至中度的COVID-19是安全的.
- 虽然病毒载量减少并不显著,但吸入IBIO123在解决呼吸道症状方面表现有前途.
- 这项研究支持对COVID-19和其他呼吸系统疾病的吸入单克隆抗体进行进一步的临床调查.
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