阿斯利康AZD7442 PROVENT III期暴露前预防临床试验取得积极结果,显著降低了有症状新冠肺炎(COVID-19)的发病率
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PROVENT主要有效性终点为接受注射后183天内出现首例SARS-CoV-2 RT-PCR阳性。所有受试者将被持续随访15个月。
所有受试者为18周岁及以上成年人,且为有望受益于该长效抗体组合药物预防机制的高危人群:免疫应答不足(对疫苗应答较弱或疫苗不耐受)或更容易感染SARS-CoV-2病毒,或有可能暴露在SARS-CoV-2病毒感染的高危环境。受试者在入组筛选时均未接种任何疫苗,且即时SARS-CoV-2血清检查为阴性。
约43%受试者为60岁及以上人群,75%以上伴有基础疾病和其他病症(包括免疫抑制性疾病或服用免疫抑制类药物,糖尿病、重度肥胖或心脏疾病,慢性阻塞性肺病,慢性肾脏和肝脏疾病),一旦感染新冠病毒发展成重症的风险较高。
一项9000余人参与的综合性临床试验正在进行中,评估AZD7442在预防和治疗新冠病毒方面的作用,包括TACKLE COVID-1913,在门诊开展的一项III期临床,以及门诊治疗和住院治疗结合的研究。此外,对于AZD7442肌肉注射和静脉注射不同给药方式的评估也在进行中。
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资料参考:阿斯利康公众号
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