Importance Remdesivir demonstrated clinical benefit in a placebo-controlled trial in patients with severe coronavirus disease 2019 (COVID-19), but its effect in patients with moderate disease is unknown. Objective To determine the efficacy of 5 or 10 days of remdesivir treatment compared with standard care on clinical status on day 11 after initiation of treatment. Design, Setting, and Participants Randomized, open-label trial of hospitalized patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and moderate COVID-19 pneumonia (pulmonary infiltrates and room-air oxygen saturation >94%) enrolled from March 15 through April 18, 2020, at 105 hospitals in the United States, Europe, and Asia. The date of final follow-up was May 20, 2020. Interventions Patients were randomized in a 1:1:1 ratio to receive a 10-day course of remdesivir (n = 197), a 5-day course of remdesivir (n = 199), or standard care (n = 200). Remdesivir was dosed intravenously at 200 mg on day 1 followed by 100 mg/d. Main Outcomes and Measures The primary end point was clinical status on day 11 on a 7-point ordinal scale ranging from death (category 1) to discharged (category 7). Differences between remdesivir treatment groups and standard care were calculated using proportional odds models and expressed as odds ratios. An odds ratio greater than 1 indicates difference in clinical status distribution toward category 7 for the remdesivir group vs the standard care group. Results Among 596 patients who were randomized, 584 began the study and received remdesivir or continued standard care (median age, 57 [interquartile range, 46-66] years; 227 [39%] women; 56% had cardiovascular disease, 42% hypertension, and 40% diabetes), and 533 (91%) completed the trial. Median length of treatment was 5 days for patients in the 5-day remdesivir group and 6 days for patients in the 10-day remdesivir group. On day 11, patients in the 5-day remdesivir group had statistically significantly higher odds of a better clinical status distribution than those receiving standard care (odds ratio, 1.65; 95% CI, 1.09-2.48; P = .02). The clinical status distribution on day 11 between the 10-day remdesivir and standard care groups was not significantly different (P = .18 by Wilcoxon rank sum test). By day 28, 9 patients had died: 2 (1%) in the 5-day remdesivir group, 3 (2%) in the 10-day remdesivir group, and 4 (2%) in the standard care group. Nausea (10% vs 3%), hypokalemia (6% vs 2%), and headache (5% vs 3%) were more frequent among remdesivir-treated patients compared with standard care. Conclusions and Relevance Among patients with moderate COVID-19, those randomized to a 10-day course of remdesivir did not have a statistically significant difference in clinical status compared with standard care at 11 days after initiation of treatment. Patients randomized to a 5-day course of remdesivir had a statistically significant difference in clinical status compared with standard care, but the difference was of uncertain clinical importance. Trial Registration ClinicalTrials.gov Identifier: NCT04292730.

中文翻译：

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瑞德西韦与标准治疗对中度 COVID-19 患者 11 天临床状态的影响

重要性 Remdesivir 在 2019 年重症冠状病毒病 (COVID-19) 患者的安慰剂对照试验中显示出临床益处，但其对中度疾病患者的影响尚不清楚。目的 确定 5 天或 10 天的瑞德西韦治疗与标准治疗在治疗开始后第 11 天的临床状态相比的疗效。设计、设置和参与者对确诊为严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 感染和中度 COVID-19 肺炎（肺部浸润和室内空气氧饱和度 >94%）的住院患者进行的随机、开放标签试验于 2020 年 3 月 15 日至 4 月 18 日在美国、欧洲和亚洲的 105 家医院登记。最终随访日期为 2020 年 5 月 20 日。 干预措施 患者按 1:1 的比例随机分组：10 天疗程的瑞德西韦 (n = 197)、5 天疗程的瑞德西韦 (n = 199) 或标准治疗 (n = 200) 的比率。瑞德西韦在第 1 天以 200 毫克静脉内给药，然后是 100 毫克/天。主要结果和测量主要终点是第 11 天的临床状态，采用 7 分顺序量表，范围从死亡（1 类）到出院（7 类）。使用比例优势模型计算瑞德西韦治疗组和标准治疗之间的差异，并表示为优势比。优势比大于 1 表示瑞德西韦组与标准治疗组的临床状态分布差异为 7 类。结果 在随机分组的 596 名患者中，584 名开始研究并接受瑞德西韦或继续标准治疗（中位年龄，57 [四分位距，46-66] 岁；227 [39%] 名女性；56% 的人患有心血管疾病，42% 的人患有高血压，40% 的人患有糖尿病），533 人（91%）完成了试验。瑞德西韦 5 天组患者的中位治疗时间为 5 天，瑞德西韦 10 天组患者的中位治疗时间为 6 天。在第 11 天，瑞德西韦 5 天组的患者比接受标准治疗的患者临床状态分布更好的几率在统计学上显着更高（几率比，1.65；95% CI，1.09-2.48；P = .02）。10 天瑞德西韦组和标准治疗组之间第 11 天的临床状态分布没有显着差异（通过 Wilcoxon 秩和检验 P = .18）。到第 28 天，9 名患者死亡：5 天瑞德西韦组 2 例 (1%)，10 天瑞德西韦组 3 例 (2%)，标准护理组 4 例 (2%)。恶心（10% 对 3%），低钾血症（6% 对 2%），与标准治疗相比，接受瑞德西韦治疗的患者出现头痛和头痛（5% 对 3%）的频率更高。结论和相关性 在中度 COVID-19 患者中，随机接受 10 天瑞德西韦疗程的患者在开始治疗后 11 天与标准治疗相比，临床状态没有统计学显着差异。与标准治疗相比，随机接受 5 天瑞德西韦疗程的患者在临床状态上存在统计学显着差异，但这种差异的临床重要性尚不确定。试验注册 ClinicalTrials.gov 标识符：NCT04292730。在开始治疗后 11 天，随机分配至 10 天疗程的瑞德西韦与标准治疗相比，临床状态没有统计学显着差异。与标准治疗相比，随机接受 5 天瑞德西韦疗程的患者在临床状态上存在统计学显着差异，但这种差异的临床重要性尚不确定。试验注册 ClinicalTrials.gov 标识符：NCT04292730。在开始治疗后 11 天，随机分配至 10 天疗程的瑞德西韦与标准治疗相比，临床状态没有统计学显着差异。与标准治疗相比，随机接受 5 天瑞德西韦疗程的患者在临床状态上存在统计学显着差异，但这种差异的临床重要性尚不确定。试验注册 ClinicalTrials.gov 标识符：NCT04292730。