一期研究评估在中度至重度COVID-19患者中的单克隆Fc-静止SARS-CoV-2抗体
Maddalena Marconato1, Christopher Hackenbruch2, Simon Jäger3
1Clinical Collaboration Unit Translational Immunology, Department of Internal Medicine, University Hospital Tübingen, Tübingen, Germany; Department of Medical Oncology and Hematology, University Hospital Zurich, Zurich, Switzerland; Cluster of Excellence iFIT (EXC2180) "Image-Guided and Functionally Instructed Tumor Therapies," University of Tübingen, Tübingen, Germany; Department of Peptide-based Immunotherapy, Institute of Immunology, University and University Hospital Tübingen, Tübingen, Germany.
这项研究发现,COR-101,一种新型单克隆抗体 (mAb),对住院COVID-19患者是安全的. 然而,它的有效性在对抗Omicron变异方面是有限的,这强调了对抗不断演变的病毒需要适应性治疗的需要.
科学领域:
- * 病毒学和免疫学
- * 传染病 传染病
- * 药理学 药理学 药理学
背景情况:
- * 严重急性呼吸系统综合征 冠状病毒2 (SARS-CoV-2) 演变对现有的疫苗和疗法构成挑战.
- *单克隆抗体 (mAbs) 面临抗药性,导致停止治疗.
- *对于中度至重度的COVID-19需要新的治疗策略.
研究的目的:
- * 评估COR-101的安全性,这是一个新的Fc-silenced mAb.
- * 探索COR-101在住院患者中的初步疗效.
- * 评估COR-101降低抗体依赖增强的潜力.
主要方法:
- *Ib/II期随机,双盲,安慰剂对照试验.
- *33名参与者在德国和乌克兰注册.
- *单剂COR-101或安慰剂作为附加治疗.
主要成果:
- *COR-101显示出良好的安全性,没有与治疗相关的严重不良事件.
- * 探索性分析显示,在剂量组和安慰剂之间,病毒清除率可变.
- * 减少对Omicron变种的体外中和,与观察到的疗效限制相关.
结论:
- *像COR-101这样的Fc静音mAbs在COVID-19患者中是可以容忍的.
- *对像Omicron这样的新兴变种的有效性有限.
- *适应性治疗策略对于对抗快速演变的病毒病原体至关重要.
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