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RDV), a nucleotide analogue prodrug that inhibits viral RNA polymerases, has demonstrated potent in vitro and in vivo activity against SARS-CoV-2 and favorable clinical efficacy and good tolerability in patients with COVID-19 treated through compassionate use. We conducted a randomized, open-label, phase 3 trial of RDV in patients with severe COVID-19. Here we report baseline characteristics associated with clinical improvement and mortality. 방법 We enrolled hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation of ≤94% on room air, and radiological evidence of pneumonia. Patients were randomized 1:1 to receive either 5 or 10 days of intravenous RDV once daily. Baseline demographic and disease characteristics associated with clinical improvement in oxygen support (≥2-point improvement on a 7-category ordinal scale ranging from discharge to death) and all-cause mortality were evaluated using Cox proportional hazards methods. 결과 Of 397 patients treated with RDV, 168 (42%) were ≥65y, 144 (36%) female, 276 (70%) white, 45 (11%) Asian, and 44 (11%) Black. 122 patients (31%) were on high-grade oxygen support (including invasive mechanical ventilation, non-invasive positive pressure ventilation, or high-flow nasal cannula) at baseline. Through median follow-up of 10d (range 1-33d), 256 patients had ≥2-point improvement and 44 had died. In a multivariable model, lower grade respiratory support (low-flow oxygen or room air), age <65y, Black race, ex-Italy regions, and no concomitant biologic medication use were significantly positively associated with ≥2-point clinical improvement (Table). Similarly, high-grade oxygen support, history of COPD, and age ≥65y were significantly associated with increased risk of all-cause mortality in multivariable analyses. 결론 In severe COVID-19 patients who received RDV, baseline oxygen support status, age <65y, Black race, ex-Italy regions, and no concomitant biologic medication were associated with higher rates of clinical improvement. Baseline oxygen support status, medical history of COPD, and age ≥65y were associated with all-cause mortality. [ABSTRACT FROM AUTHOR]

배경 Remdesivir (RDV) has demonstrated potent in vitro and in vivo activity against SARS-CoV-2 and favorable clinical efficacy and tolerability in patients with COVID-19. We conducted a randomized, open-label, phase 3 trial of RDV in patients with severe COVID-19. Here we report correlations between race/ethnicity and clinical outcomes among patients treated in the US. 방법 We enrolled hospitalized patients with confirmed COVID-19, oxygen saturation of ≤94% on room air, and radiological evidence of pneumonia. Patients were randomized 1:1 to receive 5d or 10d of intravenous RDV once daily. Among US patients, we examined rates of all-cause mortality, ≥2-point clinical improvement (on a 7-point scale ranging from discharge to death), and discharge across subgroups of patients who self-identified as non-Hispanic white (NHW), Black, Hispanic White (HW), or Asian, or Other. 결과 Overall, 397 patients received RDV, of which 229 (58%) were enrolled in the US. Of these 43 (19%) were Black, 17 (7%) HW, 18 (8%) Asian, 119 (52%) NHW, and 32 (14%) Other. At day 14, rates of clinical improvement were 84% in Black, 76% in HW, 67% in Asian, 67% in NHW, and 63% in Other (Figure). After adjustment for baseline factors, including oxygen support, demographics, and comorbidities, rate of clinical improvement was significantly higher in Black vs NHW patients (p<0.05). Pairwise differences between other race/ethnicity groups and clinical improvement, and between any of the race/ethnicity groups and either mortality or discharge, did not rise to the level of statistical significance. 결론 Our findings demonstrate that in severe COVID-19 patients treated with RDV in the US, traditionally marginalized racial/ethnic groups do not have worse clinical outcomes compared to other groups. Access to care remains an important issue and must be investigated further as a potential source of disparity with regard to COVID-19 outcomes. [ABSTRACT FROM AUTHOR]