Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary.
János Szentágothai Research Centre, University of Pécs, Pécs, Hungary.
Trials. 2021 Feb 1;22(1):112. doi: 10.1186/s13063-021-05066-2.
Coronavirus disease 2019 (COVID-19) is an infection with possible serious consequences. The plasma of recovered patients might serve as treatment, which we aim to assess in the form of a prospective meta-analysis focusing on mortality, multi-organ failure, duration of intensive care unit stay, and adverse events.
A systematic search was conducted to find relevant registered randomized controlled trials in five trial registries. A comprehensive search will be done continuously on a monthly basis in MEDLINE (via PubMed), Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science to find the results of previously registered randomized controlled trials. The selection will be done by two independent authors. Data extraction will be carried out by two other independent reviewers. Disagreements will be resolved by a third investigator. An update of the search of the registries and the first search of the databases will be done on the 21st of July. Data synthesis will be performed following the recommendations of the Cochrane Collaboration. In the case of dichotomous outcomes (mortality and organ failure), we will calculate pooled risk ratios with a 95% confidence interval (CI) from two-by-two tables (treatment Y/N, outcome Y/N). Data from models with multivariate adjustment (hazard ratios, odds ratio, risk ratio) will be preferred for the analysis. P less than 0.05 will be considered statistically significant. In the case of ICU stay, weighted mean difference with a 95% confidence interval will be calculated. Heterogeneity will be tested with I, and χ tests. Meta-analysis will be performed if at least 3 studies report on the same outcome and population.
Convalescent plasma therapy is a considerable alternative in COVID-19, which we aim to investigate in a prospective meta-analysis.
2019 年冠状病毒病（COVID-19）是一种可能导致严重后果的感染。康复患者的血浆可能可作为治疗方法，我们旨在通过一项关注死亡率、多器官衰竭、重症监护病房停留时间和不良事件的前瞻性荟萃分析来评估这种方法。
在五个试验注册处进行了系统搜索，以查找相关的已注册随机对照试验。将在每月的基础上在 MEDLINE（通过 PubMed）、Embase、Cochrane 对照试验中心注册库（CENTRAL）和 Web of Science 上进行全面搜索，以查找之前已注册的随机对照试验的结果。选择将由两名独立作者进行。数据提取将由另外两名独立评论员进行。意见分歧将由第三位调查员解决。将在 7 月 21 日对注册处的搜索进行更新，并对数据库进行首次搜索。数据合成将按照 Cochrane 协作组的建议进行。对于二项式结局（死亡率和器官衰竭），我们将根据 2x2 表（治疗 Y/N，结局 Y/N）计算汇总风险比及其 95%置信区间（CI）。对于具有多变量调整的数据（危险比、优势比、风险比），将首选用于分析。P 值小于 0.05 将被认为具有统计学意义。在 ICU 停留时间的情况下，将计算加权均数差及其 95%置信区间。将使用 I 和 χ 检验测试异质性。如果至少有 3 项研究报告了相同的结局和人群，则将进行荟萃分析。
恢复期血浆疗法是 COVID-19 的一种重要替代方法，我们旨在通过前瞻性荟萃分析对此进行研究。
