Safety and efficacy of convalescent plasma for COVID-19: the preliminary results of a clinical trial
Safety and efficacy of convalescent plasma for COVID-19: the preliminary results of a clinical trial
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DOI：
10.17816/clinpract35168
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发表时间：
2020-01-01
期刊：
影响因子：
--
通讯作者：
Troitsky, Alexander V.
中科院分区：
文献类型：
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作者：
Baklaushev, Vladimir P.;Averyanov, Alexander V.;Troitsky, Alexander V.
背景资料。由于缺乏有效的新冠肺炎治疗方法，世界各地的研究人员都在寻找各种消除SARS-CoV-2病毒的方法，包括使用恢复期血浆。瞄准。本工作的目的是研究至少1：1000滴度的含有SARS-CoV-2 S受体结合区特异性抗体的血浆用于重症新冠肺炎恢复期血浆治疗的安全性和有效性。方法：研究方法。在俄罗斯FRCC FMBA进行了一项单中心、随机、前瞻性的临床研究，86名患者被分成两组。第一组包括20例机械通气的危重患者，第二组包括66例中重度新冠肺炎伴自主呼吸的患者。第二组患者按2：1随机分为两组，第一组(46例)输注病原减毒恢复期血浆(两次，每组320毫升)，第二组(20例)，输注等量的非免疫性新鲜冰冻血浆。结果。重症新冠肺炎机械通气患者使用恢复期血浆并不影响疾病转归。本组病死率为60%，相当于本院机械通气患者的平均病死率。在第二组中，恢复期和非免疫性血浆的临床改善分别为75%和51%。在46名接受恢复期血浆治疗的患者中，有3名患者(6.5%)转为机械通气，其中两人死亡。在接受非免疫血浆的组中，也有3名患者(15%)需要机械通气，其中2人死亡。按年龄和疾病严重程度匹配，恢复期血浆组的住院死亡率为4.3%，显著低于本中心新冠肺炎医院死亡率(6.73%)，比对照组(n=150)的住院死亡率低两倍以上。结论。因此，我们证明了输注恢复期血浆是相对安全的，而且这种治疗对新冠肺炎的有效性，至少在住院的严重呼吸衰竭患者没有机械通气的情况下是有效的。在缺乏生物工程中和抗体和有效的病因治疗的情况下，使用高免恢复期血浆是治疗重症新冠肺炎的最简单、最有效的方法。
Background. The lack of effective etiotropic therapy for COVID-19 has prompted researchers around the globe to seekr various methods of SARS-CoV-2 elimination, including the use of convalescent plasma. Aim. The aim of this work was to study the safety and efficacy of the convalescence plasma treatment of severe COVID-19 using the plasma containing specific antibodies to the receptor binding domain (RBD) of SARS-CoV-2 S protein in a titer of at least 1:1000. Methods. A single-center, randomized, prospective clinical study was performed at the FRCC FMBA of Russia with the participation of 86 patients who were stratified in two groups. The first group included 20 critically ill patients who were on mechanical ventilation the second group included 66 patients with moderate to severe COVID-19 and with spontaneous respiration. The patients in the second group were randomized into two cohorts in a ratio of 2:1. In the first cohort (46 patients), pathogen-reduced convalescent plasma was transfused (twice, 320 ml each), in the second cohort (20 patients) a similar amount of non-immune freshly frozen plasma was transfused to the patients. Results. The use of plasma of convalescents in patients with severe COVID-19 being on mechanical ventilation does not affect the disease outcome in these patients. The mortality rate in this group was 60%, which corresponds to the average mortality of COVID patients on mechanical ventilation in our hospital. In the second group, clinical improvement was detected in 75% and 51%, for convalescent and non-immune plasma, respectively. Of the 46 people who received convalescent plasma, three patients (6.5%) were transferred to mechanical ventilation, two of them died. In the group receiving non-immune plasma, the need for mechanical ventilation also arose in three patients (15%), of which two died. The hospital mortality in the group of convalescent plasma was 4.3%, which is significantly lower than the average COVID-19 hospital mortality at our Center (6.73%) and more than two times lower than the hospital mortality in the control group (n=150), matched by age and by the disease severity. Conclusions. Thus, we demonstrated a relative safety of convalescent plasma transfusion and the effectiveness of such therapy for COVID-19 at least in terms of the survival of hospitalized patients with severe respiratory failure without mechanical ventilation. In the absence of bioengineered neutralizing antibodies and effective etiotropic therapy, the use of hyperimmune convalescent plasma is the simplest and most effective method of specific etiopathogenetic therapy of severe forms of COVID-19.