Remdesivir Versus Standard-of-Care for Severe Coronavirus Disease 2019 Infection: An Analysis of 28-Day Mortality

Olender, Susan; Walunas, Theresa L.; Martínez, Estebán; Perez, Katherine K.; Castagna, Antonella; Wang, Su; Kurbegov, Dax; Goyal, Parag; Ripamonti, Diego; Balani, Bindu; Rosa, Francesco Giuseppe De; Wit, Stéphane De; Kim, Shin‐Woo; Diaz, George A.; Bruno, Raffaele; Mullane, Kathleen M.; Lye, David C.; Gottlieb, Robert L; Haubrich, Richard; Chokkalingam, Anand P.; Wu, George Y.; Diaz-Cuervo, Helena; Brainard, Diana M.; Lee, I-Heng; Hu, Hao; Lin, Lanjia; Osinusi, Anu; Bernardino, José I; Boffito, Marta

doi:10.1093/ofid/ofab278

Cited by 33 publications

(48 citation statements)

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“…Of these, 5 were excluded ( Figure 1 ); therefore, six RCTs 16 - 21 and three observational cohort studies were selected. 22 - 24 The characteristics ( Table 1 ), results, risk of bias, quality of evidence, and synthesis of evidence of these studies are described below ( Tables 2 -4). No publication bias was identified.…”

Section: Resultsmentioning

confidence: 99%

Use of remdesivir in patients with COVID-19: a systematic review and meta-analysis

et al. 2022

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Objective: Studies in the literature regarding the use of remdesivir to treat COVID-19 patients have shown conflicting results. This study sought to answer questions related to the use of remdesivir for the treatment of patients hospitalized with moderate to severe COVID-19. Methods: This was a systematic review and meta-analysis including phase 3 randomized clinical trials (RCTs) and observational cohort studies selected from various databases, comparing patients hospitalized with moderate to severe COVID-19 receiving remdesivir and controls. Results: A total of 207 studies were retrieved, 9 of which met the eligibility criteria and were included in the study. The meta-analysis using RCTs alone showed no statistically significant differences regarding mortality or use of mechanical ventilation/extracorporeal membrane oxygenation between remdesivir and control groups, and the quality of evidence was moderate and low, respectively. The use of remdesivir increased the recovery rate by 6% (95% CI, 3-9); p = 0.004) and the clinical improvement rate by 7% (95% CI, 1-14); p = 0.02). Additionally, no significant differences in mortality were found between remdesivir and control groups when the meta-analysis used observational cohort studies alone (risk difference = -0.01 (95% CI, -0.02 to 0.01; p = 0.32), the quality of evidence being moderate, and the risk of adverse events was 4% ([95% CI, -0.08 to 0.01]; p = 0.09). Conclusions: The use of remdesivir for the treatment of patients with moderate to severe COVID-19 had no significant impact on clinically important outcomes.

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Section: Resultsmentioning

confidence: 99%

Use of remdesivir in patients with COVID-19: a systematic review and meta-analysis

et al. 2022

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“…Recent real-life studies support the use of Remdesivir as related to a reduction in mortality rate compared to placebo [23,25,26] and associated with a good safety profile [23,26]. This is the first report, in Italy, of Remdesivir use in patients hospitalized in the course of the year 2021.…”

Section: Discussionmentioning

confidence: 81%

Section: Discussionmentioning

confidence: 99%

“…After a median (IQR) 15 (11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23) days, clinical recovery was observed in 197 pts (89%), 159 of whom also reported virological recovery after a median (IQR) 20 (12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28) days.…”

Section: General Characteristics Of Study Populationmentioning

confidence: 99%

“…Up until nowadays, limited data exist regarding the use of Remdesivir in real life [ 22 , 23 , 24 , 25 , 26 ]. Could Remdesivir represent a therapeutic option in the current epidemiological scenario, considering the scarcity of valid therapeutic alternatives available and the frequent, rapid evolution of SARS-CoV-2 pneumonia also in patients with mild COVID-19 and recent symptom onset?…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of Remdesivir over Two Waves of the SARS-CoV-2 Pandemic

et al. 2021

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The aim of this study is to describe the features, the outcomes, and the clinical issues related to Remdesivir administration of a cohort of 220 patients (pts) with COVID-19 hospitalized throughout the last two pandemic waves in Italy. One hundred and nine pts were enrolled from 1 September 2020, to 28 February 2021 (Group A) and 111 from 1 March to 30 September 2021 (Group B). Notably, no differences were reported between the two groups neither in the timing of hospitalization. nor in the timing of Remdesivir administration from symptoms onset. Remarkably, a higher proportion of pts with severe COVID-19 was observed in Group B (25% vs. 10%, p < 0.001). At univariate and multivariate analysis, rather than the timing of Remdesivir administration, age, presence of coexisting conditions, D-dimers, and O2 flow at admission correlated positively to progression to non-invasive ventilation, especially for patients in Group B. However, the rate of admission in the Intensive Care Unit and/or death was comparable in the two groups (7% vs. 4%). Negligible variations in serum GOT, GPT, GGT, and eGFR levels were detected. A mean reduction in heart rate was noticed within the first three days of antiviral treatment (p < 0.001). Low rate of ICU admission, high rate of clinical recovery, and good drug safety were observed in COVID-19 patients treated with Remdesivir during two diverse pandemic waves.

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Association of Remdesivir Treatment With Mortality Among Hospitalized Adults With COVID-19 in the United States

et al. 2022

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ImportanceSARS-CoV-2, which causes COVID-19, poses considerable morbidity and mortality risks. Studies using data collected during routine clinical practice can supplement randomized clinical trials to provide needed evidence, especially during a global pandemic, and can yield markedly larger sample sizes to assess outcomes for important patient subgroups.ObjectiveTo evaluate the association of remdesivir treatment with inpatient mortality among patients with COVID-19 outside of the clinical trial setting.Design, Setting, and ParticipantsA retrospective cohort study in US hospitals using health insurance claims data linked to hospital chargemaster data from December 1, 2018, to May 3, 2021, was conducted among 24 856 adults hospitalized between May 1, 2020, and May 3, 2021, with newly diagnosed COVID-19 who received remdesivir and 24 856 propensity score–matched control patients.ExposureRemdesivir treatment.Main Outcomes and MeasuresAll-cause inpatient mortality within 28 days of the start of remdesivir treatment for the remdesivir-exposed group or the matched index date for the control group.ResultsA total of 24 856 remdesivir-exposed patients (12 596 men [50.7%]; mean [SD] age, 66.8 [15.4] years) and 24 856 propensity score–matched control patients (12 621 men [50.8%]; mean [SD] age, 66.8 [15.4] years) were included in the study. Median follow-up was 6 days (IQR, 4-11 days) in the remdesivir group and 5 days (IQR, 2-10 days) in the control group. There were 3557 mortality events (14.3%) in the remdesivir group and 3775 mortality events (15.2%) in the control group. The 28-day mortality rate was 0.5 per person-month in the remdesivir group and 0.6 per person-month in the control group. Remdesivir treatment was associated with a statistically significant 17% reduction in inpatient mortality among patients hospitalized with COVID-19 compared with propensity score–matched control patients (hazard ratio, 0.83 [95% CI, 0.79-0.87]).Conclusions and RelevanceIn this retrospective cohort study using health insurance claims and hospital chargemaster data, remdesivir treatment was associated with a significantly reduced inpatient mortality overall among patients hospitalized with COVID-19. Results of this analysis using data collected during routine clinical practice and state-of-the-art methods complement results from randomized clinical trials. Future areas of research include assessing the association of remdesivir treatment with inpatient mortality during the circulation of different variants and relative to time from symptom onset.

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Remdesivir Versus Standard-of-Care for Severe Coronavirus Disease 2019 Infection: An Analysis of 28-Day Mortality

Cited by 33 publications

References 29 publications

Use of remdesivir in patients with COVID-19: a systematic review and meta-analysis

Use of remdesivir in patients with COVID-19: a systematic review and meta-analysis

Efficacy and Safety of Remdesivir over Two Waves of the SARS-CoV-2 Pandemic

Association of Remdesivir Treatment With Mortality Among Hospitalized Adults With COVID-19 in the United States

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