Significantly Decreased Mortality in a Large Cohort of Coronavirus Disease 2019 (COVID-19) Patients Transfused Early with Convalescent Plasma Containing High-Titer Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Spike Protein IgG.

Significantly Decreased Mortality in a Large Cohort of Coronavirus Disease 2019 (COVID-19) Patients Transfused Early with Convalescent Plasma Containing High-Titer Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Spike Protein IgG.
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大量冠状病毒病毒疾病(COVID-19)患者的死亡率显着降低,早期含有康复性血浆,其中含有高滴度的抗疾病抗毒剂急性呼吸综合症冠状病毒2(SARS-COV-2)SPIKE蛋白IgG。

DOI:
10.1016/j.ajpath.2020.10.008
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发表时间:
2021-01
期刊:
The American journal of pathology
影响因子:
--
通讯作者:
Musser JM
Musser JM
中科院分区:
其他
文献类型:
--
作者:
Salazar E;Christensen PA;Graviss EA;Nguyen DT;Castillo B;Chen J;Lopez BV;Eagar TN;Yi X;Zhao P;Rogers J;Shehabeldin A;Joseph D;Masud F;Leveque C;Olsen RJ;Bernard DW;Gollihar J;Musser JM

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2019 冠状病毒病 (COVID-19) 恢复期血浆已成为一种有前途的疗法,并已获得美国食品和药物管理局针对住院 COVID-19 患者的紧急使用授权。我们最近报告了一项倾向评分匹配研究的中期分析结果,表明使用含有高滴度抗尖峰蛋白受体结合域 (RBD) IgG 的恢复期血浆对 COVID-19 患者进行早期治疗可显着降低死亡率。我们在此介绍对 351 名输血住院患者进行 60 天随访的结果。酶联免疫吸附测定抗 RBD IgG 滴度的前瞻性测定有助于选择和输注可用的最高滴度单位。 Ortho VITROS IgG 检测的回顾性分析显示,输血单位的中位信号/截止比为 24.0,该值远远超过美国食品和药物管理局最近要求的指定高滴度恢复期血浆的截止值 12.0。关于改变死亡率,我们的分析确定了住院后 44 小时为 COVID-19 患者输注高滴度恢复期血浆的最佳窗口。总的来说,该分析证实并扩展了我们之前的初步发现,即在住院后不久为 COVID-19 患者输注恢复期血浆中存在的高滴度抗尖峰蛋白 RBD IgG 可显着降低死亡率。
Coronavirus disease 2019 (COVID-19) convalescent plasma has emerged as a promising therapy and has been granted Emergency Use Authorization by the US Food and Drug Administration for hospitalized COVID-19 patients. We recently reported results from interim analysis of a propensity score–matched study suggesting that early treatment of COVID-19 patients with convalescent plasma containing high-titer anti-spike protein receptor binding domain (RBD) IgG significantly decreases mortality. We herein present results from a 60-day follow-up of a cohort of 351 transfused hospitalized patients. Prospective determination of enzyme-linked immunosorbent assay anti-RBD IgG titer facilitated selection and transfusion of the highest titer units available. Retrospective analysis by the Ortho VITROS IgG assay revealed a median signal/cutoff ratio of 24.0 for transfused units, a value far exceeding the recent US Food and Drug Administration–required cutoff of 12.0 for designation of high-titer convalescent plasma. With respect to altering mortality, our analysis identified an optimal window of 44 hours after hospitalization for transfusing COVID-19 patients with high-titer convalescent plasma. In the aggregate, the analysis confirms and extends our previous preliminary finding that transfusion of COVID-19 patients soon after hospitalization with high-titer anti-spike protein RBD IgG present in convalescent plasma significantly reduces mortality.
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