Efficacy of remdesivir in patients with COVID-19: a protocol for systematic review and meta-analysis of randomised controlled trials

Abstract

BackgroundDespite 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.Method and analysisWe 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.Ethics and disseminationThere 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.PROSPERO registration numberCRD42020177953.

A Systematic Review of Systematic Reviews on the COVID-19 Pandemic

“…Remdesivir significantly shortened recovery time to 11 days versus 15 days of placebo, decreased mortality rate in 14 days to 7.1% compared with 11.9% of placebo administration, and lower adverse events of 21.1% versus 27% [ 50 ]. An ongoing systematic review of randomized controlled trials on efficacy of Remdesivir in COVID-19 patients will provide us with more features of the treatment effect of this drug [ 51 ].…”

“…So far, in secondary prevention, there is no effective anti-SARS-COV-2–specific viral agent. Available antiviral medication like remdesivir which shortened hospital stay and significantly lowered mortality rate [ 51 ] associated with supportive cares for each COVID-19 cases has been used. A systematic review reported the superiority of nucleoside analog with broad-spectrum antiviral activity of Remdesivir associated with interferon beta (IFN-β) to Lopinavir/Ritonavir and IFN-β [ 73 ].…”

Clinical efficacy and safety of remdesivir in patients with COVID-19: a systematic review and network meta-analysis of randomized controlled trials

“…This study included the largest number of patients and recently concluded studies when compared with previous meta-analyses. 23 , 33 , 37 All findings were based on the analysis of RCTs and heterogeneity was low or absent across studies for all outcomes of interest, except for adverse events. However, this study also has a major limitation.…”

HIV Protease Inhibitors and Insulin Sensitivity: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

“…PICOS (participants, interventions, comparison, outcomes, and study design) ( Gebrie et al, 2020 ) was used to formulate the eligibility criteria. - Population: individuals with HIV.…”