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Protocol: Benefits and harms of remdesivir for COVID-19 in adults: A systematic review with meta-analysis

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  • Asger Sand Paludan-Müller
  • Andreas Lundh
  • Matthew J Page
  • Klaus Munkholm

Abstract

Background: Effective drug treatments for Covid-19 are needed to decrease morbidity and mortality for the individual and to alleviate pressure on health care systems. Remdesivir showed promising results in early randomised trials but subsequently a large publicly funded trial has shown less favourable results and the evidence is interpreted differently in clinical guidelines. Systematic reviews of remdesivir have been published, but none have systematically searched for unpublished data, including regulatory documents, and assessed the risk of bias due to missing evidence. Methods: We will conduct a systematic review of randomised trials comparing remdesivir to placebo or standard of care in any setting. We will include trials regardless of the severity of disease and we will include trials examining remdesivir for indications other than Covid-19 for harms analyses. We will search websites of regulatory agencies, trial registries, bibliographic databases, preprint servers and contact trial sponsors to obtain all available data, including unpublished clinical data, for all eligible trials. Our primary outcomes will be all-cause mortality and serious adverse events. Our secondary outcomes will be length of hospital stay, time to death, severe disease, and adverse events. We will assess the risk of bias using the Cochranes Risk of Bias 2 tool and the risk of bias due to missing evidence (e.g. publication bias, selective reporting bias) using the ROB-ME tool. Where appropriate we will synthesise study results by conducting random-effects meta-analysis. We will present our findings in a Summary of Findings table and rate the certainty of the evidence using the GRADE approach. Discussion: By conducting a comprehensive systematic review including unpublished data (where available), we expect to be able to provide valuable information for patients and clinicians about the benefits and harms of remdesivir for the treatment of Covid-19. This will help to ensure optimal treatment for individual patients and optimal utilisation of health care resources. Systematic review registration: CRD42021255915.

Suggested Citation

  • Asger Sand Paludan-Müller & Andreas Lundh & Matthew J Page & Klaus Munkholm, 2021. "Protocol: Benefits and harms of remdesivir for COVID-19 in adults: A systematic review with meta-analysis," PLOS ONE, Public Library of Science, vol. 16(11), pages 1-13, November.
  • Handle: RePEc:plo:pone00:0260544
    DOI: 10.1371/journal.pone.0260544
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    References listed on IDEAS

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    1. Beate Wieseler & Natalia Wolfram & Natalie McGauran & Michaela F Kerekes & Volker Vervölgyi & Petra Kohlepp & Marloes Kamphuis & Ulrich Grouven, 2013. "Completeness of Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data," PLOS Medicine, Public Library of Science, vol. 10(10), pages 1-13, October.
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