A retrospective study assessing the characteristics of COVID-19 convalescent plasma donors and donations
A retrospective study assessing the characteristics of COVID-19 convalescent plasma donors and donations
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DOI：
10.1111/trf.16208
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发表时间：
2020-12-14
期刊：
影响因子：
2.9
通讯作者：
Liumbruno, Giancarlo Maria
中科院分区：
文献类型：
--
作者：
Del Fante, Claudia;Franchini, Massimo;Liumbruno, Giancarlo Maria
背景 尽管目前许多试验正在研究恢复期血浆（CP）对重症 COVID-19 患者的安全性和有效性，但评估 CP 供体方面的正在进行和已发表的研究很少。这项回顾性研究报告了意大利在 CP 捐献者选择和捐献方面的首次经验。方法 2020 年 3 月 18 日至 6 月 30 日期间，在意大利帕维亚和曼托瓦医院的一项研究方案中招募了至少两周前从 COVID-19 中康复的 18-68 岁患者。结果 在研究期间，招募的 512 名捐献者中有 494 名被判定符合资格，并接受了 504 次血浆置换程序。百分之八十五 (437/512) 的 CP 捐献者是男性。症状恢复和 CP 捐赠之间的平均时间为 36.6 (+/- 20.0) 天。完成 488 例血浆置换程序（96.8%），每个单元分为两个亚单元（总共 976 个），平均体积为 316.2（+/- 22.7）mL。 93% (460/494) 的 CP 捐献者在捐献血浆时具有中和 IgG 滴度 >= 1:80。 2.6% (13/504) 的病例发生与血浆置换相关的不良反应；所有反应都很轻微，不需要治疗干预。捐赠者的年龄和 COVID-19 严重程度与更强的抗体反应呈正相关。 结论 这项研究证明了在意大利进行的 CP 试点计划的可行性和安全性。识别与捐献时较高中和抗体滴度呈正相关的因素（即年龄和 COVID-19 的严重程度）可能有助于优化 CP 捐献者的选择。
Background Although many trials are currently investigating the safety and efficacy of convalescent plasma (CP) in critically ill COVID-19 patients, there is a paucity of ongoing and published studies evaluating the CP donors' side. This retrospective study reports the first Italian experience on CP donors' selection and donations.Methods Patients aged 18-68 years who had recovered from COVID-19 at least 2 weeks previously were recruited between March 18 and June 30, 2020 in a study protocol at the Italian hospitals of Pavia and Mantova.Results During the study period, 494 of 512 donors recruited were judged eligible and underwent 504 plasmapheresis procedures. Eighty-five percent (437/512) of the CP donors were males. The average time between symptom recovery and CP donation was 36.6 (+/- 20.0) days. Four hundred and eighty-eight plasmapheresis procedures (96.8%) were concluded and each unit was divided into two subunits (total 976) with an average volume of 316.2 (+/- 22.7) mL. Ninety-three percent (460/494) of CP donors at the time of plasma donation had a neutralizing IgG titer >= 1:80. Plasmapheresis-related adverse reactions occurred in 2.6% (13/504) of cases; all the reactions were mild and none required therapeutic intervention. Donors' age and COVID-19 severity were positively associated with greater antibody responses.Conclusion This study demonstrates the feasibility and safety of a pilot CP program conducted in Italy. The identification of factors (ie, age and severity of COVID-19) positively associated with higher neutralizing antibody titers at the time of donation may help to optimize the selection of CP donors.