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Remdesivir Use Compared With Supportive Care in Hospitalized Patients With Severe COVID-19: A Single-Center Experience.

ABSTRACT: Background:The US Food and Drug Administration issued an Emergency Use Authorization for remdesivir use in patients with severe COVID-19. Methods:We utilized data from 2 quaternary acute care hospitals. The outcomes of interest were the impact of remdesivir on in-hospital death by day 28 and time to recovery, clinical improvement, and discharge. We utilized Cox proportional hazards models and stratified log-rank tests. Results:Two hundred twenty-four patients were included in the study. The median age was 59 years; 67.0% were male; 17/125 patients (13.6%) who received supportive care and 7/99 patients (7.1%) who received remdesivir died. The unadjusted risk for 28-day in-hospital death was lower for patients who received remdesivir compared with patients who received supportive care (hazard ratio [HR], 0.42; 95% CI, 0.16-1.08). Although this trend remained the same after adjusting for age, sex, race, and oxygen requirements on admission (adjusted HR [aHR], 0.49; 95% CI, 0.19-1.28), as well as chronic comorbidities and use of corticosteroids (aHR, 0.44; 95% CI, 0.16-1.23), it did not reach statistical significance. The use of remdesivir was not associated with an increased risk of acute kidney injury (AKI) or liver test abnormalities. Although not statistically significant, the rate ratios for time to recovery, clinical improvement, and discharge were higher in women and black or African American patients. Conclusions:Patients on remdesivir had lower, albeit not significant, all-cause in-hospital mortality, and the use of remdesivir did not increase the risk for AKI. Promising signals from this study need to be confirmed by future placebo-controlled randomized clinical trials.

SUBMITTER: Kalligeros M

PROVIDER: S-EPMC7454852 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Remdesivir Use Compared With Supportive Care in Hospitalized Patients With Severe COVID-19: A Single-Center Experience.

Kalligeros Markos M Tashima Karen T KT Mylona Evangelia K EK Rybak Natasha N Flanigan Timothy P TP Farmakiotis Dimitrios D Beckwith Curt G CG Sanchez Martha M Neill Marguerite M Johnson Jennie E JE Garland Joseph M JM Aung Su S Byrd Katrina M KM O'Brien Thomas T Pandita Aakriti A Aridi Jad J Macias Gil Raul R Larkin Jerome J Shehadeh Fadi F Mylonakis Eleftherios E

Open forum infectious diseases 20200806 10

<h4>Background</h4>The US Food and Drug Administration issued an Emergency Use Authorization for remdesivir use in patients with severe COVID-19.<h4>Methods</h4>We utilized data from 2 quaternary acute care hospitals. The outcomes of interest were the impact of remdesivir on in-hospital death by day 28 and time to recovery, clinical improvement, and discharge. We utilized Cox proportional hazards models and stratified log-rank tests.<h4>Results</h4>Two hundred twenty-four patients were included ...[more]

PMID: 33117850

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Project description:ImportanceRecent evidence suggests a multilevel inflammatory syndrome as a driving factor in some of the most severely ill coronavirus disease 2019 patients with overlapping features to other hyperinflammatory or autoimmune diseases. Therefore, plasma exchange is considered as potential therapy in these patients.ObjectivesWe characterize the longitudinal therapeutic efficacy and safety profile of plasma exchange in critically ill patients with clinical and laboratory evidences of coronavirus disease 2019-related immunopathology.Design setting and participantsA retropsective case-control study of critically ill coronavirus disease 2019 patients treated with plasma exchange at Heidelberg University Hospital between March and December 2020. Plasma exchange-treated patients were compared with coronavirus disease 2019 patients on standard therapy matched for age, gender, disease severity, and features of hyperinflammatory syndrome.Main outcome and measuresMortality rate and course of clinical and laboratory parameters in response to plasma exchange were assessed in coronavirus disease 2019 patients and in patients on standard care. A plasma volume of 50 mL per kg body weight or a maximum of 4 L was exchanged.ResultsIn total, 28 critically ill coronavirus disease 2019 patients were treated with a median of three plasma exchange procedures per patient. No relevant complications occurred during plasma exchange therapy. Inflammatory and biochemical markers of end-organ damage and endothelial activation were significantly reduced following plasma exchange together with normalization of body temperature, improved pulmonary function, and reduced vasopressor demand. Most importantly, these improvements were maintained after the last plasma exchange. In contrast, no such effects were observed in the control group, although baseline clinical and laboratory parameters were comparable. Kaplan-Meier analysis showed improved 30-day survival in the plasma exchange group compared with the control group (67.9% vs 42.9%; p = 0.044). In a multivariable analysis, the hazard ratio for death was 0.27 (95% CI, 0.11-0.68; p = 0.005) with plasma exchange versus standard care.Conclusions and relevanceOur data provide further evidence for plasma exchange as a novel therapeutic strategy in a subset of critically ill coronavirus disease 2019 patients by potentially reversing the complex coronavirus disease 2019 immunopathology. Randomized controlled trials are underway to confirm these positive results.

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Remdesivir Use Compared With Supportive Care in Hospitalized Patients With Severe COVID-19: A Single-Center Experience.

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Remdesivir Use Compared With Supportive Care in Hospitalized Patients With Severe COVID-19: A Single-Center Experience.

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