Immunohematology and Transfusion Service, IRCCS Policlinico San Matteo, Pavia, Italy.
Department of Hematology and Transfusion Medicine, Carlo Poma Hospital, Mantova, Italy.
Transfusion. 2021 Mar;61(3):830-838. doi: 10.1111/trf.16208. Epub 2020 Dec 14.
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.
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.
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.
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.
尽管目前有许多试验正在研究恢复期血浆(CP)在危重症 COVID-19 患者中的安全性和有效性,但关于 CP 供体方面的研究却很少。本回顾性研究报告了意大利首例 CP 供体选择和捐赠经验。
2020 年 3 月 18 日至 6 月 30 日,在意大利帕维亚和曼托瓦医院的一项研究方案中,招募了年龄在 18-68 岁之间、至少在 COVID-19 康复 2 周以上的患者。
在研究期间,招募的 512 名供体中有 494 名被判定符合条件,并进行了 504 次血浆置换。85%(437/512)的 CP 供体为男性。从症状恢复到 CP 捐献的平均时间为 36.6(±20.0)天。488 次血浆置换(96.8%)完成,每个单位分为两个亚单位(共 976 个),平均体积为 316.2(±22.7)mL。93%(460/494)的 CP 供体在捐献时的中和 IgG 滴度≥1:80。504 次血浆置换中有 2.6%(13/504)发生了与血浆置换相关的不良反应;所有反应均为轻度,无需治疗干预。供体年龄和 COVID-19 严重程度与更高的抗体反应呈正相关。
本研究证明了在意大利进行的一项 CP 方案试点的可行性和安全性。确定与捐赠时更高中和抗体滴度相关的因素(即年龄和 COVID-19 严重程度)可能有助于优化 CP 供体的选择。