BACKGROUND Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), none have yet been shown to be efficacious. METHODS We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only. RESULTS A total of 1063 patients underwent randomization. The data and safety monitoring board recommended early unblinding of the results on the basis of findings from an analysis that showed shortened time to recovery in the remdesivir group. Preliminary results from the 1059 patients (538 assigned to remdesivir and 521 to placebo) with data available after randomization indicated that those who received remdesivir had a median recovery time of 11 days (95% confidence interval [CI], 9 to 12), as compared with 15 days (95% CI, 13 to 19) in those who received placebo (rate ratio for recovery, 1.32; 95% CI, 1.12 to 1.55; P<0.001). The Kaplan-Meier estimates of mortality by 14 days were 7.1% with remdesivir and 11.9% with placebo (hazard ratio for death, 0.70; 95% CI, 0.47 to 1.04). Serious adverse events were reported for 114 of the 541 patients in the remdesivir group who underwent randomization (21.1%) and 141 of the 522 patients in the placebo group who underwent randomization (27.0%). CONCLUSIONS Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACCT-1 ClinicalTrials.gov number, NCT04280705.).

中文翻译：

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瑞德西韦治疗 Covid-19 - 初步报告。

背景虽然已经评估了几种治疗药物对 2019 年冠状病毒病 (Covid-19) 的治疗作用，但尚未证明任何治疗药物有效。方法 我们对因 Covid-19 住院并有下呼吸道受累证据的成人进行静脉注射瑞德西韦的双盲、随机、安慰剂对照试验。患者被随机分配接受瑞德西韦（第一天 200 毫克负荷剂量，随后每天 100 毫克，最多持续 9 天）或安慰剂，最多 10 天。主要结局是康复时间，定义为出院或仅出于感染控制目的而住院。结果 共有 1063 名患者接受了随机分组。数据和安全监测委员会建议尽早对结果进行揭盲，因为分析结果显示瑞德西韦组的恢复时间缩短了。1059 名患者（其中 538 名患者接受瑞德西韦治疗，521 名患者接受安慰剂治疗）的初步结果显示，接受瑞德西韦治疗的患者的中位恢复时间为 11 天（95% 置信区间 [CI]，9 至 12），如相比之下，接受安慰剂的患者则需要 15 天（95% CI，13 至 19）（恢复率比，1.32；95% CI，1.12 至 1.55；P<0.001）。Kaplan-Meier 估计瑞德西韦组 14 天死亡率为 7.1%，安慰剂组为 11.9%（死亡风险比，0.70；95% CI，0.47 至 1.04）。在接受随机分组的瑞德西韦组 541 名患者中，有 114 名患者报告了严重不良事件（21.1%），在接受随机分组的安慰剂组 522 名患者中，有 141 名患者报告了严重不良事件（27.0%）。结论 瑞德西韦在缩短因 Covid-19 住院且有下呼吸道感染证据的成人康复时间方面优于安慰剂。（由国家过敏和传染病研究所等资助；ACCT-1 ClinicalTrials.gov 编号，NCT04280705。）。