Effectiveness and safety of ivermectin in the treatment of COVID-19: protocol for a systematic review and meta-analysis

IntroductionIvermectin 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 evid...

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Published in:	BMJ open Vol. 11; no. 9; p. e050532
Main Authors:	Machado, Maria Letícia de Lima, Souza, Amaxsell Thiago Barros, Linhares, Paula Vívian Andrade, Martins Ferreira, Caio Fernando, Oliveira Silva, David Franciole, Martins, Rand Randall, Cobucci, Ricardo Ney
Format:	Journal Article
Language:	English
Published:	England British Medical Journal Publishing Group 17-09-2021 BMJ Publishing Group LTD BMJ Publishing Group
Series:	Protocol
Subjects:	Antiviral drugs clinical pharmacology Clinical trials Coronaviruses COVID-19 COVID-19 vaccines Dengue fever Disease prevention Global Health Humans Immune system Infections infectious diseases Intervention Ivermectin - adverse effects Meta-analysis Meta-Analysis as Topic Mortality Pandemics public health Review Literature as Topic SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2 Systematic review Systematic Reviews as Topic Treatment Outcome Ventilators Viruses clinical pharmacology public health infectious diseases
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Summary:	IntroductionIvermectin 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.Methods and analysisWe 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.Ethics and disseminationOwing to the nature of the review, ethical approval is not required. The results will be disseminated through peer-reviewed publications.PROSPERO registration numberCRD42020197395.
Bibliography:	Protocol ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23
ISSN:	2044-6055 2044-6055
DOI:	10.1136/bmjopen-2021-050532