How did we rapidly implement a convalescent plasma program?
How did we rapidly implement a convalescent plasma program?
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DOI：
10.1111/trf.15910
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发表时间：
2020-06-11
期刊：
影响因子：
2.9
通讯作者：
Shaz, Beth H.
中科院分区：
文献类型：
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作者：
Budhai, Alexandra;Wu, Annie A.;Shaz, Beth H.
自COVID-19疫情开始以来，已探索使用恢复期血浆作为可能的治疗方法。在这里，我们描述了我们作为第一个创建COVID-19恢复期血浆计划的美国组织的经验，该计划通过单一患者紧急研究新药、国家扩大使用计划和多项随机对照试验来支持其使用。在几周内，我们能够分发超过8000种产品，每周收集超过4000个单位，满足医院需求，并支持随机对照试验，以评估恢复期血浆治疗的疗效。这是通过战略规划;重新部署工作人员;以及医院，社区和公共卫生合作伙伴的积极参与。我们的合作伙伴帮助招募捐赠者，测试，患者宣传和患者可用性。该计划将继续发展，因为我们了解更多关于优化产品。有待解决的问题是抗体滴度、剂量以及在疾病的哪个阶段输血。
Since the beginning of the COVID-19 pandemic, the use of convalescent plasma as a possible treatment has been explored. Here we describe our experience as the first U.S. organization creating a COVID-19 convalescent plasma program to support its use through the single-patient emergency investigational new drug, the National Expanded Access Program, and multiple randomized controlled trials. Within weeks, we were able to distribute more than 8000 products, scale up collections to more than 4000 units per week, meet hospital demand, and support randomized controlled trials to evaluate the efficacy of convalescent plasma treatment. This was through strategic planning; redeployment of staff; and active engagement of hospital, community, and public health partners. Our partners helped with donor recruitment, testing, patient advocacy, and patient availability. The program will continue to evolve as we learn more about optimizing the product. Remaining issues to be resolved are antibody titers, dose, and at what stage of disease to transfuse.