Severe Acute Respiratory Syndrome Coronavirus 2 Convalescent Plasma Versus Standard Plasma in Coronavirus Disease 2019 Infected Hospitalized Patients in New York: A Double-Blind Randomized Trial.
Severe Acute Respiratory Syndrome Coronavirus 2 Convalescent Plasma Versus Standard Plasma in Coronavirus Disease 2019 Infected Hospitalized Patients in New York: A Double-Blind Randomized Trial.
复制标题
DOI：
10.1097/ccm.0000000000005066
复制
发表时间：
2021-07-01
影响因子：
8.8
通讯作者：
中科院分区：
文献类型：
--
作者：
四份同行评审的出版物报告了2019年冠状病毒病感染恢复期血浆的随机对照试验结果；没有在美国进行，也没有使用标准血浆作为比较物。目的：确定2019冠状病毒病患者的恢复期血浆是否会增加对严重急性呼吸综合征冠状病毒2的抗体并改善预后。双盲随机对照试验。在纽约的医院聚合酶链反应患者记录了2019冠状病毒感染。患者随机（4:1）接受2u恢复期血浆和标准血浆。在血浆单位和试验接受者中检测了严重急性呼吸综合征冠状病毒2型抗体。在给予恢复期血浆紧急使用授权后，受试者终止登记。74名患者被随机分组。在基线时，急性生理和慢性健康评估II的平均（sd）评分（23.4[5.6]和22.5[6.6]），插管患者的百分比（19%和20%），以及从症状发作到随机化的中位（四分位数范围）天数分别为9（6-18）和9(6-15)，恢复期血浆组与标准血浆组相似。恢复期血浆具有较高的中和活性（滴度中位数[四分位数范围]1:526[1:359-1:786]），给药后严重急性呼吸综合征冠状病毒2型抗体增加14.4%，而标准血浆给药后抗体减少8.6% （p = 0.005）。无呼吸机至28天（主要研究终点）无差异：恢复期血浆组和标准血浆组的中位数（四分位数范围）分别为28（2-28）和28 （0-28;p = 0.86）。两组中有20%的受试者在世界卫生组织量表中获得大于或等于2点的改善（p = 0.99）。恢复期血浆组90天的全因死亡率低于标准血浆组（27% vs 33%; p = 0.63），但没有统计学意义。基线插管患者死亡时间的关键预先指定亚组分析具有统计学意义；然而，样本量很小。2019冠状病毒病感染住院患者给予恢复期血浆可增加对严重急性呼吸综合征冠状病毒病2的抗体，但与改善预后无关。
Four peer-reviewed publications have reported results from randomized controlled trials of convalescent plasma for coronavirus disease 2019 infection; none were conducted in the United States nor used standard plasma as a comparator. To determine if administration of convalescent plasma to patients with coronavirus disease 2019 increases antibodies to severe acute respiratory syndrome coronavirus 2 and improves outcome. Double-blind randomized controlled trial. Hospital in New York. Patients with polymerase chain reaction documented coronavirus disease 2019 infection. Patients were randomized (4:1) to receive 2 U of convalescent plasma versus standard plasma. Antibodies to severe acute respiratory syndrome coronavirus 2 were measured in plasma units and in trial recipients. Enrollment was terminated after emergency use authorization was granted for convalescent plasma. Seventy-four patients were randomized. At baseline, mean (sd) Acute Physiology and Chronic Health Evaluation II score (23.4 [5.6] and 22.5 [6.6]), percent of patients intubated (19% and 20%), and median (interquartile range) days from symptom onset to randomization of 9 (6–18) and 9 (6–15), were similar in the convalescent plasma versus standard plasma arms, respectively. Convalescent plasma had high neutralizing activity (median [interquartile range] titer 1:526 [1:359–1:786]) and its administration increased antibodies to severe acute respiratory syndrome coronavirus 2 by 14.4%, whereas standard plasma administration led to an 8.6% decrease (p = 0.005). No difference was observed for ventilator-free days through 28 days (primary study endpoint): median (interquartile range) of 28 (2–28) versus 28 (0–28; p = 0.86) for the convalescent plasma and standard plasma groups, respectively. A greater than or equal to 2 point improvement in the World Health Organization scale was achieved by 20% of subjects in both arms (p = 0.99). All-cause mortality through 90 days was numerically lower in the convalescent plasma versus standard plasma groups (27% vs 33%; p = 0.63) but did not achieve statistical significance. A key prespecified subgroup analysis of time to death in patients who were intubated at baseline was statistically significant; however, sample size numbers were small. Administration of convalescent plasma to hospitalized patients with coronavirus disease 2019 infection increased antibodies to severe acute respiratory syndrome coronavirus disease 2 but was not associated with improved outcome.