Graduate Program in Sciences Applied to Women's Health, Maternidade Escola Januário Cicco (MEJC/EBSERH), Federal University of Rio Grande do Norte Health Sciences Center, Natal, Brazil.
Pharmacy, Federal University of Rio Grande do Norte Health Sciences Center, Natal, Brazil.
BMJ Open. 2021 Sep 17;11(9):e050532. doi: 10.1136/bmjopen-2021-050532.
Ivermectin is a drug with antiviral properties and has been proposed as an alternative treatment for patients with COVID-19, in some countries; however, there is limited evidence to support its clinical use. Accordingly, the aim of this review and meta-analysis is to obtain superior evidence on the effectiveness and safety of ivermectin in treatment of COVID-19.
We will search in the medical databases and International Clinical Trials Registry Platform databases for randomised clinical trials and quasi-randomised trials published from December 2019. The criteria for inclusion are that infection needs to be confirmed by a real-time PCR or serology test, and the effect of ivermectin has been compared with placebo, symptomatic treatment or no treatment. We will exclude observational studies and clinical trials that involved patients with symptoms suggestive of COVID-19, but without a laboratorial diagnosis. Outcomes of interest include mortality, time to symptom resolution, time of hospitalisation, frequency of invasive mechanical ventilation and extracorporeal membrane oxygenation, incidence of severe acute respiratory syndrome, admission to intensive care unit, viral load, PCR-negative status, percentage of infection after prophylactic use, and total incidence of adverse and side effects. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Two reviewers will independently select the studies and assess their eligibility. Two other reviewers will independently extract data from each study. Meta-analysis will then be carried out using fixed-effects or random-effects model, using the mean difference for continuous outcomes and the relative risk for dichotomous outcomes. Bias risk will be assessed using the Cochrane risk-of-bias tool. The quality of evidence for each outcome will be assessed using GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology. Review Manager V.5.3.5 will be used for synthesis and subgroup analysis.
Owing to the nature of the review, ethical approval is not required. The results will be disseminated through peer-reviewed publications.
CRD42020197395.
伊维菌素是一种具有抗病毒特性的药物，已在一些国家被提议作为 COVID-19 患者的替代治疗方法；然而，支持其临床应用的证据有限。因此，本综述和荟萃分析的目的是获得关于伊维菌素治疗 COVID-19 的有效性和安全性的更优证据。
我们将在医学数据库和国际临床试验注册平台数据库中搜索 2019 年 12 月以来发表的随机临床试验和准随机试验。纳入标准为感染需要通过实时 PCR 或血清学检测证实，并且伊维菌素的效果已与安慰剂、对症治疗或不治疗进行比较。我们将排除观察性研究和涉及有 COVID-19 症状但无实验室诊断的患者的临床试验。感兴趣的结局包括死亡率、症状缓解时间、住院时间、有创机械通气和体外膜氧合的频率、严重急性呼吸综合征的发生率、入住重症监护病房、病毒载量、PCR 阴性状态、预防性使用后的感染百分比以及总不良反应发生率。研究选择将遵循系统评价和荟萃分析的 Preferred Reporting Items 指南。两名审查员将独立选择研究并评估其合格性。另外两名审查员将独立从每项研究中提取数据。然后将使用固定效应或随机效应模型进行荟萃分析，对于连续结局使用均数差，对于二分类结局使用相对风险。使用 Cochrane 偏倚风险工具评估偏倚风险。使用 GRADE（推荐评估、制定与评价）方法评估每个结局的证据质量。Review Manager V.5.3.5 将用于综合和亚组分析。
由于综述的性质，不需要伦理批准。结果将通过同行评审出版物传播。
PROSPERO 注册号：CRD42020197395。
