Evaluation of a COVID-19 convalescent plasma program at a U.S. academic medical center.
Evaluation of a COVID-19 convalescent plasma program at a U.S. academic medical center.
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DOI：
10.1371/journal.pone.0277707
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发表时间：
2022
期刊：
影响因子：
3.7
通讯作者：
中科院分区：
文献类型：
--
作者：
在COVID-19大流行开始时的治疗空白中，围绕COVID-19恢复期血浆（CCP）的科学和临床兴趣达到了临界水平。迄今为止，CCP文献主要关注安全性和有效性结果，但很少关注实施结果或经验。专家意见认为，如果CCP在COVID-19治疗中发挥作用，那么它必须处于病程的早期，并且必须提供足够高滴度的中和抗体（nAb）。文献中缺少对地方CCP项目如何作为流行病准备和应对的一部分实施的全面评估，包括考虑核心组成部分和人员，以及时和持续的方式满足足够合格CCP的需求。为了解决这一差距，我们对美国大型学术医疗中心北卡罗来纳大学医学中心（UNCMC）的当地CCP项目进行了评估，并围绕Reach、有效性、采用、实施和维护（RE-AIM）框架的维度进行了评估，以系统地描述与实施相关的关键指标。我们将评估与项目目标保持一致，即覆盖患有严重或危重COVID-19的目标人群，融入医院范围内的大流行应对结构，适应不断变化的环境，并在同情使用扩大准入计划（EAP）时代和随机对照试验（RCT）时代长期维持项目。在EAP时代，与同期没有当地计划的附属医院相比，UNCMC CCP计划与入院后更快的CCP输注相关：UNCMC CCP计划的中位时间为29.6小时（四分位数范围，IQR: 21.2-48.1），而附属医院的中位时间为47.6小时（IQR: 32.6-71.6）；(P < 0.0001)。在EAP的87例CCP接受者中，68例（78.2%）接受了含有FDA推荐的最低nAb滴度≥1:160的CCP。无论通过随机对照试验或同情使用机制接受治疗，向住院患者提供CCP的效率相同。研究发现，在资源丰富的学术医疗中心，通过重新部署训练有素的实验室和临床人员，可以实现当地CCP收集、治疗和临床试验计划的快速实施。这些数据为考虑将CCP作为大流行综合应对的一部分使用的卫生系统提供了重要的务实考虑。
Amidst the therapeutic void at the onset of the COVID-19 pandemic, a critical mass of scientific and clinical interest coalesced around COVID-19 convalescent plasma (CCP). To date, the CCP literature has focused largely on safety and efficacy outcomes, but little on implementation outcomes or experience. Expert opinion suggests that if CCP has a role in COVID-19 treatment, it is early in the disease course, and it must deliver a sufficiently high titer of neutralizing antibodies (nAb). Missing in the literature are comprehensive evaluations of how local CCP programs were implemented as part of pandemic preparedness and response, including considerations of the core components and personnel required to meet demand with adequately qualified CCP in a timely and sustained manner. To address this gap, we conducted an evaluation of a local CCP program at a large U.S. academic medical center, the University of North Carolina Medical Center (UNCMC), and patterned our evaluation around the dimensions of the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to systematically describe key implementation-relevant metrics. We aligned our evaluation with program goals of reaching the target population with severe or critical COVID-19, integrating into the structure of the hospital-wide pandemic response, adapting to shifting landscapes, and sustaining the program over time during a compassionate use expanded access program (EAP) era and a randomized controlled trial (RCT) era. During the EAP era, the UNCMC CCP program was associated with faster CCP infusion after admission compared with contemporaneous affiliate hospitals without a local program: median 29.6 hours (interquartile range, IQR: 21.2–48.1) for the UNCMC CCP program versus 47.6 hours (IQR 32.6–71.6) for affiliate hospitals; (P<0.0001). Sixty-eight of 87 CCP recipients in the EAP (78.2%) received CCP containing the FDA recommended minimum nAb titer of ≥1:160. CCP delivery to hospitalized patients operated with equal efficiency regardless of receiving treatment via a RCT or a compassionate-use mechanism. It was found that in a highly resourced academic medical center, rapid implementation of a local CCP collection, treatment, and clinical trial program could be achieved through re-deployment of highly trained laboratory and clinical personnel. These data provide important pragmatic considerations critical for health systems considering the use of CCP as part of an integrated pandemic response.
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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：
12.7
作者：
Glasgow, RE;Vogt, TM;Boles, SM
通讯作者：
Boles, SM
影响因子：
6.4
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.
通讯作者：
Margolis, David M.
DOI：
10.1093/infdis/jiaa803
发表时间：
2021-03-03
期刊：
The Journal of infectious diseases
影响因子：
--
作者：
Girardin RC;Dupuis AP;Payne AF;Sullivan TJ;Strauss D;Parker MM;McDonough KA
通讯作者：
McDonough KA
影响因子：
2.9
作者：
Budhai, Alexandra;Wu, Annie A.;Shaz, Beth H.
通讯作者：
Shaz, Beth H.