TY - JOUR
T1 - Remdesivir use compared with supportive care in hospitalized patients with severe COVID-19
T2 - A single-center experience
AU - Kalligeros, Markos
AU - Tashima, Karen T.
AU - Mylona, Evangelia K.
AU - Rybak, Natasha
AU - Flanigan, Timothy P.
AU - Farmakiotis, Dimitrios
AU - Beckwith, Curt G.
AU - Sanchez, Martha
AU - Neill, Marguerite
AU - Johnson, Jennie E.
AU - Garland, Joseph M.
AU - Aung, Su
AU - Byrd, Katrina M.
AU - O’Brien, Thomas
AU - Pandita, Aakriti
AU - Aridi, Jad
AU - Gil, Raul Macias
AU - Larkin, Jerome
AU - Shehadeh, Fadi
AU - Mylonakis, Eleftherios
N1 - Funding Information:
This work was facilitated by the Providence/Boston Center for AIDS Research (P30AI042853) and the NIAID AIDS Clinical Trials Unit UM1 A1069412.
Publisher Copyright:
© The Author(s) 2020.
PY - 2020/10/1
Y1 - 2020/10/1
N2 - 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.
AB - 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.
KW - COVID-19
KW - Efficacy
KW - Remdesivir
KW - SARS-cov-2
KW - Safety
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U2 - 10.1093/ofid/ofaa319
DO - 10.1093/ofid/ofaa319
M3 - Article
AN - SCOPUS:85096688629
SN - 2328-8957
VL - 7
JO - Open Forum Infectious Diseases
JF - Open Forum Infectious Diseases
IS - 10
ER -