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Mortality Benefit of Remdesivir in COVID-19: A Systematic Review and Meta-Analysis.

ABSTRACT: Importance/Background: During current public health emergency of COVID-19 pandemic, repurposing of existing antiviral drugs may be an efficient strategy since there is no proven effective treatment. Published literature shows Remdesivir has broad-spectrum antiviral activity against numerous RNA viruses and has been recently recognized as a promising therapy against SARS-CoV-2. Methods: A systematic search was conducted for full length manuscripts published between inception and July 19th, 2020 focussing on efficacy and safety of Remdesivir in COVID-19. The primary outcomes were defined as mortality rate and median days to recovery based on the available pooled data. The secondary outcome was adverse events rate and drug discontinuation rate. Statistical Analysis: All outcomes were performed using Comprehensive Meta-Analysis software package (Bio stat, Englewood, NJ, USA). Results: A total of 1,895 patients from 9 studies were included in this qualitative synthesis. In patients treated with Remdesivir, the mean recovery time was 15.84 days (95% CI 11.68-20, SE 2.12; I ² = 97.24) and the pooled mortality rate was 11.3% (95% CI 7.9-16%; I ² = 74.85). However, treatment with Remdesivir was associated with adverse effects (55.3%, 95% CI 31.5-76.9%; I ² = 97.66) eventually warranting the discontinuation of the drug (17.8%, 95% CI 8.6-33.1%; I ² = 95.64). The meta-analysis of three clinical trials indicated that administration of Remdesivir significantly reduces the mortality compared to the placebo (OR 0.70, 95% CI 0.58-0.84, p ? 0.001; I ² = 16.6). Conclusions and Relevance: The result of contemporary meta-analysis suggests mortality benefit with Remdesivir in COVID-19 and median recovery time was over 2 weeks. The pooled mortality with Remdesivir was found to be very low, and this analysis can shed light on this potential treatment for COVID-19 patients.

SUBMITTER: Bansal V

PROVIDER: S-EPMC7873594 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Mortality Benefit of Remdesivir in COVID-19: A Systematic Review and Meta-Analysis.

Bansal Vikas V Mahapure Kiran S KS Bhurwal Abhishek A Gupta Ishita I Hassanain Sahar S Makadia Janaki J Madas Nimisha N Armaly Paige P Singh Romil R Mehra Ishita I O'Horo John C JC Kashyap Rahul R

Frontiers in medicine 20210127

<b>Importance/Background:</b> During current public health emergency of COVID-19 pandemic, repurposing of existing antiviral drugs may be an efficient strategy since there is no proven effective treatment. Published literature shows Remdesivir has broad-spectrum antiviral activity against numerous RNA viruses and has been recently recognized as a promising therapy against SARS-CoV-2. <b>Methods:</b> A systematic search was conducted for full length manuscripts published between inception and Jul ...[more]

PMID: 33585508

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Project description:BackgroundEffective 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.MethodsWe 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.DiscussionBy 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 registrationCRD42021255915.

Project description:BackgroundEfficacy and safety of treatments for hospitalized COVID-19 are uncertain. We systematically reviewed efficacy and safety of remdesivir for the treatment of COVID-19.MethodsStudies evaluating remdesivir in adults with hospitalized COVID-19 were searched in several engines until August 21, 2020. Primary outcomes included all-cause mortality, clinical improvement or recovery, need for invasive ventilation, and serious adverse events (SAEs). Inverse variance random effects meta-analyses were performed.ResultsWe included four randomized controlled trials (RCTs) (n = 2296) [two vs. placebo (n = 1299) and two comparing 5-day vs. 10-day regimens (n = 997)], and two case series (n = 88). Studies used intravenous remdesivir 200mg the first day and 100mg for four or nine more days. One RCT (n = 236) was stopped early due to AEs; the other three RCTs reported outcomes between 11 and 15 days. Time to recovery was decreased by 4 days with remdesivir vs. placebo in one RCT (n = 1063), and by 0.8 days with 5-days vs. 10-days of therapy in another RCT (n = 397). Clinical improvement was better for 5-days regimen vs. standard of care in one RCT (n = 600). Remdesivir did not decrease all-cause mortality (RR 0.71, 95%CI 0.39 to 1.28, I2 = 43%) and need for invasive ventilation (RR 0.57, 95%CI 0.23 to 1.42, I2 = 60%) vs. placebo at 14 days but had fewer SAEs; 5-day decreased need for invasive ventilation and SAEs vs. 10-day in one RCT (n = 397). No differences in all-cause mortality or SAEs were seen among 5-day, 10-day and standard of care. There were some concerns of bias to high risk of bias in RCTs. Heterogeneity between studies could be due to different severities of disease, days of therapy before outcome determination, and how ordinal data was analyzed.ConclusionsThere is paucity of adequately powered and fully reported RCTs evaluating effects of remdesivir in hospitalized COVID-19 patients. Until stronger evidence emerges, we cannot conclude that remdesivir is efficacious for treating COVID-19.

Project description:ObjectivesEvaluation of remdesivir, an RNA polymerase inhibitor, for effectiveness in adults with COVID-19.Data sourcesElectronic search for eligible articles of PubMed, Cochrane Central and clinicaltrials.gov was performed on 20 September 2020.Participants and study eligibility criteriaOnly randomised controlled trials (RCTs) evaluating efficacy of remdesivir in COVID-19 were included for meta-analysis.InterventionsRemdesivir was compared with standard of care.Primary and secondary outcomesPrimary outcome was mortality and secondary outcomes were time to clinical improvement and safety outcomes like serious adverse events, respiratory failure.Study appraisal and synthesis methodsData synthesis was done with Cochrane review manager 5 (RevMan) V.5.3. Cochrane risk of bias V.2.0 tool was used for methodological quality assessment. The GRADE pro GDT was applied for overall quality of evidence.Results52 RCTs were screened and 4 studies were included in analysis, with total of 7324 patients. No mortality benefit was observed with remdesivir versus control group (OR=0.92 (95% CI 0.79 to 1.07), p=0.30, moderate quality evidence). Significantly higher rates of clinical improvement (OR=1.52 (95% CI 1.24 to 1.87), p<0.0001, low quality) and faster time to clinical improvement (HR=1.28 (95% CI 1.12 to 1.46), p=0.0002, very low quality) was observed with remdesivir versus control group. Significant decrease was found in the risk of serious adverse events (RR=0.75 (95% CI 0.62 to 0.90), p=0.0003, low quality); however, no difference was found in the risk of respiratory failure (RR=0.85 (95% CI 0.41 to 1.77), p=0.67, very low quality evidence) with remdesivir.ConclusionsAs per the evidence from current review, remdesivir has shown no mortality benefit (moderate quality evidence) in the treatment of COVID-19. From a cost-benefit perspective, it is our personal opinion that it should not be recommended for use, especially in low and lower middle income countries.Trial registration numberPROSPERO registration number: CRD42020189517.

Project description:BackgroundThe coronavirus disease 2019 (COVID-19) patients with diabetes mellitus (DM) are at high risk of fatal outcomes. This meta-analysis quantifies the prevalence of mortality among (1) diabetic and (2) non-diabetic, and (3) the prevalence of DM, in hospitalized COVID-19 patients.MethodsPublished studies were retrieved from four electronic databases (PubMed, Embase, Scopus, and medRxiv) and appraised critically utilizing the National Heart, Lung, and Blood Institute's tool. Meta-analyses were performed using the random-effects model. The measures of heterogeneity were ascertained by I- squared (I 2 ) and Chi-squared (Chi 2 ) tests statistics. Predictors of heterogeneity were quantified using meta-regression models.ResultsOf the reviewed 475 publications, 22 studies (chiefly case series (59.09 %)), sourcing data of 45,775 hospitalized COVID-19 patients, were deemed eligible. The weighted prevalence of mortality in hospitlized COVID-19 patients with DM (20.0 %, 95 % CI: 15.0-26.0; I 2 , 96.8 %) was 82 % (1.82-time) higher than that in non-DM patients (11.0 %, 95 % CI: 5.0-16.0; I 2 , 99.3 %). The prevalence of mortality among DM patients was highest in Europe (28.0 %; 95 % CI: 14.0-44.0) followed by the United States (20.0 %, 95 % CI: 11.0-32.0) and Asia (17.0 %, 95 % CI: 8.0-28.0). Sample size and severity of the COVID-19 were associated (p < 0.05) with variability in the prevalence of mortality. The weighted prevalence of DM among hospitalized COVID-19 patients was 20 % (95 % confidence interval [CI]: 15-25, I 2 , 99.3 %). Overall, the quality of the studies was fair.ConclusionsHospitalized COVID-19 patients were appreciably burdened with a high prevalence of DM. DM contributed to the increased risk of mortality among hospitalized COVID-19 patients compared to non-DM patients, particularly among critically ill patients. Registration: PROSPERO (registration no. CRD42020196589).Supplementary informationThe online version contains supplementary material available at 10.1007/s40200-021-00779-2.

Dataset Information

Mortality Benefit of Remdesivir in COVID-19: A Systematic Review and Meta-Analysis.

Publications

Mortality Benefit of Remdesivir in COVID-19: A Systematic Review and Meta-Analysis.

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