National Institute of Blood Diseases & Bone Marrow Transplantation, Karachi, Pakistan.
Hayatabad Medical Complex, Peshawar, Pakistan.
BMC Infect Dis. 2021 Sep 27;21(1):1014. doi: 10.1186/s12879-021-06451-7.
Convalescent plasma(CP) was utilized as potential therapy during COVID-19 pandemic in Pakistan. The study aimed at appraisal of CP transfusion safety and usefulness in COVID pneumonia.
Single arm, MEURI study design of non-randomized open label trial was conducted in five centers. Patients werecategorized as moderately severe, severe, and critical. The primary endpoint was a) improvement in clinical status and change in category of disease severity; secondary endpoint was b) CP ability to halt disease progression to invasive ventilation. CP transfused to hospitalized patients. Statistical tests including median (interquartile ranges), Mann-Whitney U test, Fisher's exact test using SPSS ver. 23, ANOVA and Chi-square test were applied for the analysis of results parameters before and after CP treatment. SOFA score was applied for multiorgan failure in severe and critical cases.
A total of 50 adult patients; median age 58.5 years (range: 29-92 years) received CP with infusion titers; median 1:320 U/mL (Interquartile range 1:80-1:320) between April 4 to May 5, 2020. The median time from onset of symptoms to enrollment in trial was 3 to 7 days with shortness of breath and lung infiltration as severity criterion. In 35 (70%) recipients, oxygen saturation improved from 80 to 95% within 72h, with resolution of lung infiltrates. Primary endpoint was achieved in 44 (88%) recipients whereas secondary endpoint was achieved in 42 (84%). No patient experienced severe adverse events. A high SOFA score (> 7) correlated with deaths in severe and critical patients. Eight (16%) patients expired due to comorbidities; cardiac arrest in 2 (4%), multiorgan failure secondary to cytokine storm in 5 (10%) and ventilator associated complications in 1 (2%).
CP transfusion can be used as a safe and useful treatment in moderately severe and severe patients.
The trial registration number is NCT04352751 ( https://www.irct.ir/search/result?query=IRCT20200414047072N1 ). Trial Registration date is 28th April 2020.
在巴基斯坦 COVID-19 大流行期间，恢复期血浆（CP）被用作潜在的治疗方法。本研究旨在评估 CP 输血在 COVID 肺炎中的安全性和有效性。
采用非随机开放标签试验的单臂 MEURI 研究设计，在五个中心进行。患者分为中度严重、严重和危急。主要终点是 a）临床状况改善和疾病严重程度分类变化；次要终点是 b）CP 阻止疾病进展为侵袭性通气的能力。CP 输注给住院患者。使用 SPSS 版本 23 进行统计检验，包括中位数（四分位间距）、Mann-Whitney U 检验、Fisher 确切检验、方差分析和卡方检验，用于分析 CP 治疗前后的结果参数。SOFA 评分用于严重和危急病例的多器官衰竭。
共有 50 名成年患者；中位年龄 58.5 岁（范围：29-92 岁），于 2020 年 4 月 4 日至 5 月 5 日输注 CP，输注滴度中位数为 1:320 U/mL（四分位间距 1:80-1:320）。从症状发作到入组试验的中位时间为 3 至 7 天，以呼吸急促和肺部浸润为严重标准。在 35 名（70%）接受者中，氧饱和度在 72 小时内从 80%提高到 95%，肺部浸润消退。主要终点在 44 名（88%）接受者中实现，次要终点在 42 名（84%）接受者中实现。无患者发生严重不良事件。严重和危急患者中，高 SOFA 评分（>7）与死亡相关。8 名（16%）患者因合并症死亡；2 名（4%）患者因心脏骤停，5 名（10%）患者因细胞因子风暴引起多器官衰竭，1 名（2%）患者因呼吸机相关并发症死亡。
CP 输血可作为中度严重和严重患者的安全有效治疗方法。
试验注册号为 NCT04352751（https://www.irct.ir/search/result?query=IRCT20200414047072N1）。试验注册日期为 2020 年 4 月 28 日。
