Hospital Israelita Albert Einstein, São Paulo, SP, Brazil.
Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brazil.
Einstein (Sao Paulo). 2021 Apr 19;19:eRW6186. doi: 10.31744/einstein_journal/2021RW6186. eCollection 2021.
The objective of this study was to highlight the global scientific effort to fight the SARS-CoV-2, addressing the preliminary results of passive immunization through convalescent plasma. We performed a search at the major databases of interventional clinical trial protocols about the transfusion of convalescent plasma in patients with COVID-19, as well as, published articles (n≥25), using the following search strategy: [(COVID-19 OR SARS-CoV-2 OR nCoV-2019) AND (Convalescent plasma OR Plasma exchange) AND (Treatment OR Therapy)]. A total of 24 interventional clinical trial protocols (advanced in phases II-III, III, and IV) were included in this review, as well as three studies that had enough outcomes to evaluate the efficacy of convalescent plasma therapy for patients with COVID-19. All interventional clinical trial protocols applied approximately 500mL of convalescent plasma (from single or more donations) in hospitalized patients, mainly in patients with severe disease associated with standard therapy for COVID-19, and compared to placebo or standard therapy plus specific drugs. Most of interventional clinical trial protocols are multicenter, and the phase IV studies are recruiting at intercontinental centers of North America, Oceania, Europe, but most are recruiting center inside their own county. The three studies published reported similar approach of convalescent plasma intervention with decrease in length of stay, mortality, with less than 4% of adverse events, mainly for treating critical cases with life-threatening disease. All advanced clinical trials focused on convalescent plasma therapy in patients with COVID-19 hospitalized in severe conditions, and the preliminary results provide strong evidence for therapy for the COVID-19 patients.
本研究旨在强调全球科学界为抗击 SARS-CoV-2 所做的努力，介绍恢复期血浆被动免疫的初步结果。我们在主要的干预性临床试验方案数据库中搜索了 COVID-19 患者输注恢复期血浆的内容，以及已发表的文章（n≥25），使用了以下搜索策略：[(COVID-19 或 SARS-CoV-2 或 nCoV-2019) AND (恢复期血浆或血浆置换) AND (治疗或疗法)]。本综述共纳入 24 项干预性临床试验方案（处于 II-III 期、III 期和 IV 期的先进阶段），以及 3 项有足够结果评估恢复期血浆治疗 COVID-19 患者疗效的研究。所有干预性临床试验方案均在住院患者中应用约 500mL 的恢复期血浆（来自单次或多次捐献），主要在与 COVID-19 标准治疗相关的重症患者中，与安慰剂或标准治疗加特定药物进行比较。大多数干预性临床试验方案为多中心，IV 期研究在北美、大洋洲、欧洲的洲际中心招募，但大多数招募中心在自己的国家内。已发表的三项研究报告了恢复期血浆干预的类似方法，可缩短住院时间、降低死亡率，不良事件发生率低于 4%，主要用于治疗有生命威胁疾病的危重症患者。所有先进的临床试验均聚焦于 COVID-19 住院患者的恢复期血浆治疗，初步结果为 COVID-19 患者的治疗提供了强有力的证据。
