Outcomes of Convalescent Plasma with Defined High versus Lower Neutralizing Antibody Titers against SARS-CoV-2 among Hospitalized Patients: CoronaVirus Inactivating Plasma (CoVIP) Study.
Outcomes of Convalescent Plasma with Defined High versus Lower Neutralizing Antibody Titers against SARS-CoV-2 among Hospitalized Patients: CoronaVirus Inactivating Plasma (CoVIP) Study.
复制标题
DOI：
10.1128/mbio.01751-22
复制
发表时间：
2022-10-26
期刊：
影响因子：
6.4
通讯作者：
Margolis, David M.
中科院分区：
文献类型：
--
作者：
Bartelt, Luther A.;Markmann, Alena J.;Nelson, Bridget;Keys, Jessica;Root, Heather;Henderson, Heather, I;Kuruc, JoAnn;Baker, Caroline;Bhowmik, D. Ryan;Hou, Yixuan J.;Premkumar, Lakshmanane;Cornaby, Caleb;Schmitz, John L.;Weiss, Susan;Park, Yara;Baric, Ralph;de Silva, Aravinda M.;Lachiewicz, Anne;Napravnik, Sonia;van Duin, David;Margolis, David M.
关键词：
COVID-19恢复期血浆（CCP）是一种早期且广泛采用的重症COVID-19公认疗法。随机对照试验和观察性研究的结果未能证明CCP对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染的明确治疗作用。这些不确定的发现背后是不同CCP供体之间中和抗体（nAb）浓度的广泛异质性。我们进行这项研究，以评估nAb滴度定义的CCP在学术转诊医院住院的成人中的有效性和安全性。SARS-CoV-2核酸扩增检测呈阳性且症状持续时间<10天的患者符合条件。除了标准治疗外，参与者还接受了nAb滴度> 1：640（高滴度组）或≥ 1：160至1：640（标准滴度组）的CCP。主要临床结局为出院时间，次要结局为死亡率和呼吸支持。通过CCP滴度对比不良事件。在2020年8月28日至12月4日期间，316名参与者接受了筛查，55名接受了CCP，14名和41名分别接受了高滴度和标准滴度CCP。接受高滴度CCP的受试者的出院时间短于接受标准滴度CCP的受试者，这说明死亡是一种竞争性事件（风险比，1.94; 95%置信区间[CI]，1.05 - 3.58; Gray's P = 0.02）。到第28天，接受高滴度与标准滴度的参与者中分别有4名（29%）和23名（56%）发生严重不良事件（SAE）（≥ 3级）（风险比，0.51; 95%CI，0.21至1.22; Fisher's P = 0.12）。未观察到治疗相关AE。(This该研究已在www.example.com注册，注册号为NCT 04524507）。
COVID-19 convalescent plasma (CCP) was an early and widely adopted putative therapy for severe COVID-19. Results from randomized control trials and observational studies have failed to demonstrate a clear therapeutic role for CCP for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Underlying these inconclusive findings is a broad heterogeneity in the concentrations of neutralizing antibodies (nAbs) between different CCP donors. We conducted this study to evaluate the effectiveness and safety of nAb titer-defined CCP in adults admitted to an academic referral hospital. Patients positive by a SARS-CoV-2 nucleic acid amplification test and with symptoms for <10 days were eligible. Participants received either CCP with nAb titers of >1:640 (high-titer group) or ≥1:160 to 1:640 (standard-titer group) in addition to standard of care treatments. The primary clinical outcome was time to hospital discharge, with mortality and respiratory support evaluated as secondary outcomes. Adverse events were contrasted by CCP titer. Between 28 August and 4 December 2020, 316 participants were screened, and 55 received CCP, with 14 and 41 receiving high- versus standard-titer CCP, respectively. Time to hospital discharge was shorter among participants receiving high- versus standard-titer CCP, accounting for death as a competing event (hazard ratio, 1.94; 95% confidence interval [CI], 1.05 to 3.58; Gray’s P = 0.02). Severe adverse events (SAEs) (≥grade 3) occurred in 4 (29%) and 23 (56%) of participants receiving the high versus standard titer, respectively, by day 28 (risk ratio, 0.51; 95% CI, 0.21 to 1.22; Fisher’s P = 0.12). There were no observed treatment-related AEs. (This study has been registered at ClinicalTrials.gov under registration no. NCT04524507).
登录
查看更多内容
影响因子：
8.8
作者：
通讯作者：
--
影响因子：
64.5
作者：
Hou, Yixuan J.;Okuda, Kenichi;Baric, Ralph S.
通讯作者：
Baric, Ralph S.
影响因子：
64.8
作者：
Barnes CO;Jette CA;Abernathy ME;Dam KA;Esswein SR;Gristick HB;Malyutin AG;Sharaf NG;Huey-Tubman KE;Lee YE;Robbiani DF;Nussenzweig MC;West AP Jr;Bjorkman PJ
通讯作者：
Bjorkman PJ
影响因子：
15.9
作者：
Egloff, Shanna A. Arnold;Junglen, Angela;LeMaistre, Charles F.
通讯作者：
LeMaistre, Charles F.
影响因子：
15.9
作者：
Bar, Katharine J.;Shaw, Pamela A.;Tebas, Pablo
通讯作者：
Tebas, Pablo