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Evaluation of the Treatment Efficacy and Safety of Remdesivir for COVID-19: a Meta-analysis.

ABSTRACT: Remdesivir is one of few FDA-approved treatments for severe cases of Coronavirus Disease 2019 (COVID-19). To better assess its efficacy and safety, we conducted a meta-analysis to systematically identify and synthesize existing findings. We conducted a comprehensive literature search among six electronic databases and unpublished studies. Random-effects meta-analyses were performed to summarize the risk ratio (RR) and rate estimates from eligible studies. Funnel plots, the Egger test, and the trim and fill analysis were used to detect publication bias. Thirteen eligible studies were included in this meta-analysis, giving a pooled sample size of 10,002 COVID-19 hospitalized patients (5068 administered remdesivir; 4934 control). Among patients on remdesivir, we synthesized mortality (15%, 95% confidence interval [CI]: 9%, 22%), clinical improvement (64%, 95% CI: 51%, 78%), recovery (70%, 95% CI: 57%, 83%), hospital discharge (74%, 95% CI: 60%, 87%), serious adverse effect (SAE) (21%, 95% CI:13%, 29%), and Grade 3 or 4 adverse effect (AE) (30%, 95% CI: 12%, 48%). Patients on remdesivir were 17% (RR: 0.83, 95% CI: 0.65, 1.06) less likely to die than those within the control group. Additionally, remdesivir had favorable outcomes in terms of clinical improvement, recovery, and hospital discharge. Lastly, non-mechanically ventilated patients had better overall clinical outcomes than mechanically ventilated patients. Remdesivir shows a moderate-favorable treatment efficacy among hospitalized COVID-19 patients with disproportionate impact among non-mechanically ventilated patients; however, a substantial proportion of COVID-19 patients may suffer from SAE or Grade 3 or 4 AE during the treatment course.

Supplementary information

The online version contains supplementary material available at 10.1007/s42399-021-01014-y.

SUBMITTER: Tao J

PROVIDER: S-EPMC8346348 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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:BackgroundCOVID-19 is a type of pneumonia caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection that was identified in December 2019. Corticosteroid therapy was empirically used for clinical treatment in the early stage of the disease outbreak; however, data regarding its efficacy and safety are controversial. The aim of this study was to evaluate the efficacy and safety of corticosteroid therapy in patients with COVID-19.MethodsThe PubMed, Cochrane Library, EMBASE, Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang, and China Science and Technology Journal (VIP) databases were searched for studies. Data on clinical improvement, mortality, virus clearance time, adverse events (AEs), utilization of mechanical ventilation, length of intensive care unit (ICU) hospitalization, and hospital stay were extracted by two authors independently. Study quality was assessed by the Newcastle Ottawa Scale (cohort studies). The pooled data were meta-analyzed using a random effects model, and the quality of evidence was rated using the GRADE approach.ResultsEleven cohort studies (corticosteroid group vs control group), two retrospective cohort studies (without control group), and seven case studies were identified. A total of 2840 patients were included. Compared with the control treatments, corticosteroid therapy was associated with clinical recovery (RR = 1.30, 95% CI [0.98, 1.72]) and a significantly shortened length of ICU hospitalization (RR = -6.50; 95% CI [-7.63 to -5.37]), but it did not affect the mortality ((RR = 1.59; 95% CI [0.69-3.66], I2 = 93.5%), utilization of mechanical ventilation (RR = 0.35; 95% CI [0.10, 1.18]), duration of symptoms (WMD = 1.69; 95% CI [-0.24 to 3.62]) or virus clearance time (RR = 1.01; 95% CI [-0.91 to 2.92], I2 = 57%) in COVID-19 patients. Treatment with corticosteroids in patients with COVID-19 may cause mild adverse outcomes. The quality of evidence was low or very low for all outcomes.ConclusionThe findings of our study indicate that corticosteroid therapy is not highly effective, but it appears to improve prognosis and promote clinical recovery in patients with severe COVID-19.

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Evaluation of the Treatment Efficacy and Safety of Remdesivir for COVID-19: a Meta-analysis.

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