School of Pharmacy, College of Health Sciences, Mekelle University, Mekelle, Ethiopia
Addis Ababa University, College of Health Sciences, Center for Innovative Drug Development and Therapeutic Trials for Africa, Addis Ababa, Ethiopia.
BMJ Open. 2020 Jun 4;10(6):e039159. doi: 10.1136/bmjopen-2020-039159.
Despite global containment measures to fight the coronavirus disease 2019 (COVID-19), the pandemic continued to rise, rapidly spread across the world, and resulting in 2.6 million confirmed cases and 185 061 deaths worldwide as of 23 April 2020. Yet, there are no approved vaccines or drugs to make the disease less deadly, while efforts are underway. Remdesivir, a nucleotide-analogue antiviral drug developed for Ebola, is determined to prevent and stop infections with COVID-19, while results are yet controversial. Here, we aim to conduct a systematic review and meta-analysis of randomised controlled trials (RCTs) to evaluate the efficacy of remdesivir in patients with COVID-19.
We will search MEDLINE-PubMed, Embase, Cochrane Library, ClinicalTrials.gov and Google scholar databases for articles published as of 30 June 2020 and we will complete the study on 30 August 2020. We will follow the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 guidelines for the design and reporting of the results. We will include RCTs that assessed the efficacy of remdesivir versus placebo or standard of care. The primary endpoint will be time to clinical recovery. The secondary endpoints will be proportion of participants relieved from clinical symptoms defined at the time (in hours) from initiation of the study treatment, all-cause mortality, discharged date, frequency of respiratory progression and treatment-emergent adverse events. RevMan V.5.3 software will be used for statistical analysis. Random effects model will be carried out to calculate mean differences for continuous outcome data and risk ratio for dichotomous outcome data between remdesivir and placebo or standard of care.
There are no ethical considerations associated with this study as we will use publicly available data from previously published studies. We plan to publish results in open-access peer-reviewed journals and present at international and national conferences.
CRD42020177953.
尽管全球采取了遏制 2019 年冠状病毒病（COVID-19）的措施，但大流行仍在继续，迅速在全球蔓延，截至 2020 年 4 月 23 日，全球已确诊病例 260 万例，死亡 185061 例。然而，目前尚无批准的疫苗或药物可降低该病的致命性，尽管正在努力研究。瑞德西韦是一种为埃博拉病毒开发的核苷酸类似物抗病毒药物，被确定可预防和阻止 COVID-19 的感染，但其效果仍存在争议。在这里，我们旨在对随机对照试验（RCT）进行系统评价和荟萃分析，以评估瑞德西韦在 COVID-19 患者中的疗效。
我们将检索 MEDLINE-PubMed、Embase、Cochrane 图书馆、ClinicalTrials.gov 和 Google Scholar 数据库，以获取截至 2020 年 6 月 30 日发表的文章，并于 2020 年 8 月 30 日完成研究。我们将遵循系统评价和荟萃分析报告的首选报告项目（PRISMA-P）2015 指南进行设计和报告结果。我们将纳入评估瑞德西韦与安慰剂或标准治疗比较的疗效的 RCT。主要终点是临床康复时间。次要终点是从研究治疗开始时（以小时为单位）定义的临床症状缓解的参与者比例、全因死亡率、出院日期、呼吸进展频率和治疗出现的不良事件。RevMan V.5.3 软件将用于统计分析。对于连续性结局数据，将采用随机效应模型计算瑞德西韦与安慰剂或标准治疗之间的均数差；对于二分类结局数据，将采用风险比。
由于本研究将使用先前发表的研究中公开提供的数据，因此不存在与该研究相关的伦理问题。我们计划在开放获取的同行评议期刊上发表结果，并在国际和国内会议上进行报告。
PROSPERO 注册号：CRD42020177953。
