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

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...

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Autores principales: Kalligeros, Markos, Tashima, Karen T, Mylona, Evangelia K, Rybak, Natasha, Flanigan, Timothy P, Farmakiotis, Dimitrios, Beckwith, Curt G, Sanchez, Martha, Neill, Marguerite, Johnson, Jennie E, Garland, Joseph M, Aung, Su, Byrd, Katrina M, O’Brien, Thomas, Pandita, Aakriti, Aridi, Jad, Macias Gil, Raul, Larkin, Jerome, Shehadeh, Fadi, Mylonakis, Eleftherios
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7454852/
https://www.ncbi.nlm.nih.gov/pubmed/33117850
http://dx.doi.org/10.1093/ofid/ofaa319
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author Kalligeros, Markos
Tashima, Karen T
Mylona, Evangelia K
Rybak, Natasha
Flanigan, Timothy P
Farmakiotis, Dimitrios
Beckwith, Curt G
Sanchez, Martha
Neill, Marguerite
Johnson, Jennie E
Garland, Joseph M
Aung, Su
Byrd, Katrina M
O’Brien, Thomas
Pandita, Aakriti
Aridi, Jad
Macias Gil, Raul
Larkin, Jerome
Shehadeh, Fadi
Mylonakis, Eleftherios
author_facet Kalligeros, Markos
Tashima, Karen T
Mylona, Evangelia K
Rybak, Natasha
Flanigan, Timothy P
Farmakiotis, Dimitrios
Beckwith, Curt G
Sanchez, Martha
Neill, Marguerite
Johnson, Jennie E
Garland, Joseph M
Aung, Su
Byrd, Katrina M
O’Brien, Thomas
Pandita, Aakriti
Aridi, Jad
Macias Gil, Raul
Larkin, Jerome
Shehadeh, Fadi
Mylonakis, Eleftherios
author_sort Kalligeros, Markos
collection PubMed
description 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.
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spelling pubmed-74548522020-08-31 Remdesivir Use Compared With Supportive Care in Hospitalized Patients With Severe COVID-19: A Single-Center Experience Kalligeros, Markos Tashima, Karen T Mylona, Evangelia K Rybak, Natasha Flanigan, Timothy P Farmakiotis, Dimitrios Beckwith, Curt G Sanchez, Martha Neill, Marguerite Johnson, Jennie E Garland, Joseph M Aung, Su Byrd, Katrina M O’Brien, Thomas Pandita, Aakriti Aridi, Jad Macias Gil, Raul Larkin, Jerome Shehadeh, Fadi Mylonakis, Eleftherios Open Forum Infect Dis Major Articles 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. Oxford University Press 2020-08-06 /pmc/articles/PMC7454852/ /pubmed/33117850 http://dx.doi.org/10.1093/ofid/ofaa319 Text en © The Author(s) 2020. Published by Oxford University Press on behalf of Infectious Diseases Society of America. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Major Articles
Kalligeros, Markos
Tashima, Karen T
Mylona, Evangelia K
Rybak, Natasha
Flanigan, Timothy P
Farmakiotis, Dimitrios
Beckwith, Curt G
Sanchez, Martha
Neill, Marguerite
Johnson, Jennie E
Garland, Joseph M
Aung, Su
Byrd, Katrina M
O’Brien, Thomas
Pandita, Aakriti
Aridi, Jad
Macias Gil, Raul
Larkin, Jerome
Shehadeh, Fadi
Mylonakis, Eleftherios
Remdesivir Use Compared With Supportive Care in Hospitalized Patients With Severe COVID-19: A Single-Center Experience
title Remdesivir Use Compared With Supportive Care in Hospitalized Patients With Severe COVID-19: A Single-Center Experience
title_full Remdesivir Use Compared With Supportive Care in Hospitalized Patients With Severe COVID-19: A Single-Center Experience
title_fullStr Remdesivir Use Compared With Supportive Care in Hospitalized Patients With Severe COVID-19: A Single-Center Experience
title_full_unstemmed Remdesivir Use Compared With Supportive Care in Hospitalized Patients With Severe COVID-19: A Single-Center Experience
title_short Remdesivir Use Compared With Supportive Care in Hospitalized Patients With Severe COVID-19: A Single-Center Experience
title_sort remdesivir use compared with supportive care in hospitalized patients with severe covid-19: a single-center experience
topic Major Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7454852/
https://www.ncbi.nlm.nih.gov/pubmed/33117850
http://dx.doi.org/10.1093/ofid/ofaa319
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