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新冠康复者血浆治疗重症或危及生命的新冠肺炎患者的配对队列研究

Matched Cohort Study of Convalescent COVID-19 Plasma Treatment in Severely or Life Threateningly Ill COVID-19 Patients.

作者信息

Klapholz Marc, Pentakota Sri Ram, Zertuche Juan-Pablo, McKenna Marshall, Roque Willy, Forsberg Mark, Packer Johnathan, Lal Devika S, Dever Lisa

机构信息

Rutgers New Jersey Medical School, Department of Medicine, Newark, New Jersey, USA.

出版信息

Open Forum Infect Dis. 2021 Jan 4;8(2):ofab001. doi: 10.1093/ofid/ofab001. eCollection 2021 Feb.

Abstract

BACKGROUND

The utility of convalescent coronavirus disease 2019 (COVID-19) plasma (CCP) in the current pandemic is not well defined. We sought to evaluate the safety and efficacy of CCP in severely or life threateningly ill COVID-19 patients when matched with a contemporaneous cohort.

METHODS

Patients with severe or life-threatening COVID-19 were treated with CCP according to Food and Drug Administration criteria, prioritization by an interdisciplinary team, and based on CCP availability. Individual-level matched controls (1:1) were identified from patients admitted during the prior month when no CCP was available. The safety outcome was freedom from adverse transfusion reaction, and the efficacy outcome was a composite of death or worsening O support. Demographic, clinical, and laboratory data were analyzed by univariate and multivariable regression analyses accounting for matched design.

RESULTS

Study patients (n = 94, 47 matched pairs) were 62% male with a mean age of 58, and 98% (90/94) were minorities (53% Hispanic, 45% Black, non-Hispanic) in our inner-city population. Seven-day composite and mortality outcomes suggested a nonsignificant benefit in CCP-treated patients (adjusted hazard ratio [aHR], 0.70; 95% CI, 0.23-2.12; = .52; aHR, 0.23; 95% CI, 0.04-1.51; = .13, respectively). Stratification by pretransfusion mechanical ventilation status showed no differences between groups. No serious transfusion reactions occurred.

CONCLUSIONS

In this short-term matched cohort study, transfusion with CCP was safe and showed a nonsignificant association with study outcomes. Randomized and larger trials to identify appropriate timing and dosing of CCP in COVID-19 are warranted.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT04420988.

摘要

背景

2019冠状病毒病(COVID-19)康复期血浆(CCP)在当前大流行中的效用尚不明确。我们试图评估CCP在与同期队列匹配的重症或危及生命的COVID-19患者中的安全性和疗效。

方法

根据美国食品药品监督管理局的标准、跨学科团队的优先排序并基于CCP的可获得性,对重症或危及生命的COVID-19患者进行CCP治疗。从上个月无CCP可用时入院的患者中确定个体水平的匹配对照(1:1)。安全结局为无输血不良反应,疗效结局为死亡或氧疗支持恶化的复合情况。对人口统计学、临床和实验室数据进行单变量和多变量回归分析,并考虑匹配设计。

结果

研究患者(n = 94, 47对匹配)中62%为男性,平均年龄58岁,在我们的市中心人群中98%(90/94)为少数族裔(53%西班牙裔,45%非西班牙裔黑人)。7天复合结局和死亡率结局表明CCP治疗的患者有不显著的获益(调整后风险比[aHR],0.70;95%置信区间[CI],0.23 - 2.12;P = 0.52;aHR, 0.23;95% CI, 0.04 - 1.51;P = 0.13,分别)。按输血前机械通气状态分层显示组间无差异。未发生严重输血反应。

结论

在这项短期匹配队列研究中,输注CCP是安全的,且与研究结局存在不显著关联。有必要进行随机且规模更大的试验以确定CCP在COVID-19中的合适时机和剂量。

试验注册

ClinicalTrials.gov标识符:NCT04420988。

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