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新墨西哥州恢复期血浆和接受者中严重急性呼吸综合征冠状病毒 2 中和抗体滴度:2019 年冠状病毒病患者的开放性治疗研究。

Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Antibody Titers in Convalescent Plasma and Recipients in New Mexico: An Open Treatment Study in Patients With Coronavirus Disease 2019.

机构信息

Center for Global Health, Department of Internal Medicine, University of New Mexico, Albuquerque, New Mexico, USA.

Division of Infectious Diseases, Department of Internal Medicine, University of New Mexico, Albuquerque, New Mexico, USA.

出版信息

J Infect Dis. 2020 Oct 13;222(10):1620-1628. doi: 10.1093/infdis/jiaa505.

Abstract

BACKGROUND

Convalescent plasma (CP) is a potentially important therapy for coronavirus disease 2019 (COVID-19). However, knowledge regarding neutralizing antibody (NAb) titers in donor plasma and their impact in patients with acute COVID-19 remains largely undetermined. We measured NAb titers in CP and in patients with acute COVID-19 before and after transfusion through the traditional Food and Drug Administration investigational new drug pathway.

METHODS

We performed a single-arm interventional trial measuring NAb and total antibody titers before and after CP transfusion over a 14-day period in hospitalized patients with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 infection.

RESULTS

NAb titers in the donor CP units were low (<1:40 to 1:160) and had no effect on recipient neutralizing activity 1 day after transfusion. NAb titers were detected in 6 of 12 patients on enrollment and in 11 of 12 at ≥2 time points. Average titers peaked on day 7 and declined toward day 14 (P = .004). Nab titers and immunoglobulin G levels were correlated in donor plasma units (ρ = 0.938; P < .001) and in the cumulative patient measures (ρ = 0.781; P < .001).

CONCLUSIONS

CP infusion did not alter recipient NAb titers. Prescreening of CP may be necessary for selecting donors with high titers of neutralizing activity for infusion into patients with COVID-19.

CLINICAL TRIALS REGISTRATION

NCT04434131.

摘要

背景

恢复期血浆(CP)是治疗 2019 年冠状病毒病(COVID-19)的一种潜在重要疗法。然而,关于供体血浆中的中和抗体(NAb)滴度及其在急性 COVID-19 患者中的影响的知识在很大程度上仍未确定。我们通过传统的食品和药物管理局调查性新药途径测量了 CP 中和抗体和总抗体滴度,并在 CP 输注前后对急性 COVID-19 患者进行了测量。

方法

我们进行了一项单臂干预性试验,在住院的严重急性呼吸综合征冠状病毒 2 感染患者中,在 14 天内通过 CP 输注前后测量 NAb 和总抗体滴度。

结果

供体 CP 单位中的 NAb 滴度较低(<1:40 至 1:160),并且在输注后 1 天对受体的中和活性没有影响。在入组时,有 6 名患者中有 6 名,在 12 名患者中有 11 名在≥2 个时间点检测到 NAb 滴度。平均滴度在第 7 天达到峰值,并在第 14 天下降(P=0.004)。在供体血浆单位中,Nab 滴度和免疫球蛋白 G 水平呈正相关(ρ=0.938;P<0.001),在累积患者测量中也呈正相关(ρ=0.781;P<0.001)。

结论

CP 输注未改变受体 NAb 滴度。对于输注 COVID-19 患者的高中和活性的 CP,可能需要对 CP 进行预筛选。

临床试验注册

NCT04434131。

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Convalescent plasma - Is it useful for treating SARS Co-V2 infection?恢复期血浆——对治疗新冠病毒感染有用吗?
Indian J Med Microbiol. 2020 Jul-Dec;38(3 & 4):252-260. doi: 10.4103/ijmm.IJMM_20_358.

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