SAFETY AND EFFICACY OF INTRAVENOUS IMMUNOGLOBULIN G CONTAINING HIGH ANTI-WEST

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。主要目的：评估和描述Omr-IgG-am TM在确诊或疑似西尼罗河病毒疾病住院患者中的安全性和耐受性。评估静脉注射Omr-IgG-am TM后特异性抗西尼罗抗体的药动学，评估在已知或疑似西尼罗病毒感染的患者接受西尼罗病毒特异性IVIg与接受安慰剂的类似患者中，Omr-IgG-am TM在降低发病率和死亡率方面的功效，进一步表征严重西尼罗病毒感染的自然史

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Primary Objective: To assess and characterized the safety and tolerability of Omr-IgG-am TM in a population of hospitalized patients with confirmed or suspected WNV disease Secondary Objective: To assess pharmacokinectics of specific anti-West Nile antibodies following intravenous administration of Omr-IgG-am TM To estimate efficacy of Omr-IgG-am TM in reducing morbidity and mortality, for patients with known or suspected WNV infection who receive WNV specific IVIg versus similar patients who receive either placebo To further characterize the natural history of sever WNV infection