Salazar Eric, Christensen Paul A, Graviss Edward A, Nguyen Duc T, Castillo Brian, Chen Jian, Lopez Bevin V, Eagar Todd N, Yi Xin, Zhao Picheng, Rogers John, Shehabeldin Ahmed, Joseph David, Masud Faisal, Leveque Christopher, Olsen Randall J, Bernard David W, Gollihar Jimmy, Musser James M
Department of Pathology and Genomic Medicine, Houston Methodist Hospital, Houston, Texas; Department of Pathology and Laboratory Medicine, Weill Cornell Medical College, New York, New York.
Department of Pathology and Genomic Medicine, Houston Methodist Hospital, Houston, Texas.
Am J Pathol. 2021 Jan;191(1):90-107. doi: 10.1016/j.ajpath.2020.10.008. Epub 2020 Nov 4.
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.
2019冠状病毒病（COVID-19）康复期血浆已成为一种有前景的治疗方法，并已获得美国食品药品监督管理局的紧急使用授权，用于住院的COVID-19患者。我们最近报告了一项倾向评分匹配研究的中期分析结果，表明用含有高滴度抗刺突蛋白受体结合域（RBD）IgG的康复期血浆对COVID-19患者进行早期治疗可显著降低死亡率。我们在此展示了对351名接受输血的住院患者队列进行60天随访的结果。通过酶联免疫吸附测定法前瞻性测定抗RBD IgG滴度有助于选择和输注可得的最高滴度单位。采用奥森VITROS IgG测定法进行的回顾性分析显示，输注单位的中位信号/截断比为24.0，该值远超过美国食品药品监督管理局最近规定的用于指定高滴度康复期血浆的截断值12.0。关于改变死亡率，我们的分析确定了住院后44小时这一最佳窗口期，在此期间用高滴度康复期血浆输注COVID-19患者。总体而言，该分析证实并扩展了我们之前的初步发现，即住院后不久用康复期血浆中存在的高滴度抗刺突蛋白RBD IgG输注COVID-19患者可显著降低死亡率。
