Remdesivir for Severe Coronavirus Disease 2019 (COVID-19) Versus a Cohort Receiving Standard of Care.
Remdesivir for Severe Coronavirus Disease 2019 (COVID-19) Versus a Cohort Receiving Standard of Care.
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雷米替韦治疗 2019 年严重冠状病毒病（COVID-19）与接受标准护理的队列对比。
DOI：
10.1093/cid/ciaa1041
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发表时间：
2021-12-06
期刊：
影响因子：
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通讯作者：
Bernardino, Jose I
中科院分区：
文献类型：
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作者：
Olender, Susan A;Perez, Katherine K;Bernardino, Jose I
背景技术：我们比较了抗病毒药物Remdesivir与标准治疗在严重冠状病毒病成人中的疗效2019使用来自3期Remdesivir试验和接受标准治疗的严重COVID-19患者的回顾性队列的数据，GS-US-540-5773是一项正在进行的III期、随机、开放标签试验，比较了两个疗程的remdesivir（remdesivir队列）。GS-US-540-5807是一项正在接受标准治疗的患者（非瑞德西韦队列）中进行的真实世界、回顾性队列临床结局研究。两项研究的入选标准相似：患者确诊严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）感染，住院，室内空气氧饱和度≤94%或需要补充氧气，并有肺浸润。使用稳定化的治疗加权逆概率多变量逻辑回归来估计Remdesivir与标准治疗的治疗效果。主要终点是第14天恢复的患者比例，根据7分临床状态顺序量表进行二分。一个关键的次要终点是mortality.RESULTS：治疗加权程序的逆概率后，312和818例患者分别在remdesivir和非remdesivir队列中计数。在第14天，Remdesivir队列中有74.4%的患者恢复，而非Remdesivir队列中有59.0%的患者恢复（校正比值比[aOR] 2.03：95%置信区间[CI]：1.34-3.08，P <0.001）。在第14天，Remdesivir队列中7.6%的患者死亡，而非Remdesivir队列中12.5%的患者死亡（aOR 0.38，95% CI：0.22 - 0.68，P = 0.001）。在这个比较分析中，到第14天，与标准治疗相比，Remdesivir与显著更高的恢复率和62%的死亡率相关。重症COVID-19患者的护理治疗。临床试验注册：NCT 04292899和EUPAS 34303。
BACKGROUND: We compared the efficacy of the antiviral agent, remdesivir, versus standard-of-care treatment in adults with severe coronavirus disease 2019 (COVID-19) using data from a phase 3 remdesivir trial and a retrospective cohort of patients with severe COVID-19 treated with standard of care.METHODS: GS-US-540-5773 is an ongoing phase 3, randomized, open-label trial comparing two courses of remdesivir (remdesivir-cohort). GS-US-540-5807 is an ongoing real-world, retrospective cohort study of clinical outcomes in patients receiving standard-of-care treatment (non-remdesivir-cohort). Inclusion criteria were similar between studies: patients had confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, were hospitalized, had oxygen saturation ≤94% on room air or required supplemental oxygen, and had pulmonary infiltrates. Stabilized inverse probability of treatment weighted multivariable logistic regression was used to estimate the treatment effect of remdesivir versus standard of care. The primary endpoint was the proportion of patients with recovery on day 14, dichotomized from a 7-point clinical status ordinal scale. A key secondary endpoint was mortality.RESULTS: After the inverse probability of treatment weighting procedure, 312 and 818 patients were counted in the remdesivir- and non-remdesivir-cohorts, respectively. At day 14, 74.4% of patients in the remdesivir-cohort had recovered versus 59.0% in the non-remdesivir-cohort (adjusted odds ratio [aOR] 2.03: 95% confidence interval [CI]: 1.34-3.08, P < .001). At day 14, 7.6% of patients in the remdesivir-cohort had died versus 12.5% in the non-remdesivir-cohort (aOR 0.38, 95% CI: .22-.68, P = .001).CONCLUSIONS: In this comparative analysis, by day 14, remdesivir was associated with significantly greater recovery and 62% reduced odds of death versus standard-of-care treatment in patients with severe COVID-19.CLINICAL TRIALS REGISTRATION: NCT04292899 and EUPAS34303.