Compassionate Use of Remdesivir for Patients with Severe Covid-19
Compassionate Use of Remdesivir for Patients with Severe Covid-19
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DOI：
10.1056/nejmoa2007016
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发表时间：
2020-06-11
影响因子：
158.5
通讯作者：
Flanigan, T.
中科院分区：
文献类型：
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作者：
Grein, J.;Ohmagari, N.;Flanigan, T.
一组患有严重 Covid-19 的患者根据同情使用方案接受了瑞德西韦治疗。 68% 的患者的氧支持状态得到改善，中位随访 18 天后，总体死亡率为 13%。 背景 瑞德西韦 (Remdesivir) 是一种抑制病毒 RNA 聚合酶的核苷酸类似物前药，已在体外显示出抗 SARS-CoV-2 的活性。方法 我们在同情用药的基础上向住院的 Covid-19（由 SARS-CoV-2 感染引起的疾病）患者提供瑞德西韦。患者是指呼吸周围空气或接受氧气支持时氧饱和度为 94% 或更低的确诊 SARS-CoV-2 感染者。患者接受了为期 10 天的瑞德西韦疗程，包括第一天静脉注射 200 毫克，然后在剩余 9 天的治疗中每天注射 100 毫克。本报告基于2020年1月25日至2020年3月7日期间接受瑞德西韦治疗且至少有随后1天临床数据的患者的数据。结果 在接受至少一剂瑞德西韦的 61 名患者中，有 8 名患者的数据无法分析（其中 7 名患者没有治疗后数据，1 名患者存在剂量错误）。在分析数据的 53 名患者中，22 名来自美国，22 名来自欧洲或加拿大，9 名来自日本。基线时，30 名患者 (57%) 正在接受机械通气，4 名患者 (8%) 正在接受体外膜肺氧合。在中位随访 18 天期间，36 名患者 (68%) 的氧支持水平有所改善，其中 30 名接受机械通气的患者 (57%) 中有 17 名拔管。共有25名患者（47%）出院，7名患者（13%）死亡；接受有创通气的患者死亡率为 18%（34 例中的 6 例），而未接受有创通气的患者的死亡率为 5%（19 例中的 1 例）。结论 在这组因重症 Covid-19 住院且接受同情用药瑞德西韦治疗的患者中，53 名患者中有 36 名 (68%) 出现临床改善。疗效的衡量需要持续进行瑞德西韦治疗的随机、安慰剂对照试验。 （由吉利德科学公司资助。）
A cohort of patients with severe Covid-19 received treatment with remdesivir under a compassionate-use protocol. Improvement in oxygen-support status was observed in 68% of patients, and overall mortality was 13% over a median follow-up of 18 days.Background Remdesivir, a nucleotide analogue prodrug that inhibits viral RNA polymerases, has shown in vitro activity against SARS-CoV-2. Methods We provided remdesivir on a compassionate-use basis to patients hospitalized with Covid-19, the illness caused by infection with SARS-CoV-2. Patients were those with confirmed SARS-CoV-2 infection who had an oxygen saturation of 94% or less while they were breathing ambient air or who were receiving oxygen support. Patients received a 10-day course of remdesivir, consisting of 200 mg administered intravenously on day 1, followed by 100 mg daily for the remaining 9 days of treatment. This report is based on data from patients who received remdesivir during the period from January 25, 2020, through March 7, 2020, and have clinical data for at least 1 subsequent day. Results Of the 61 patients who received at least one dose of remdesivir, data from 8 could not be analyzed (including 7 patients with no post-treatment data and 1 with a dosing error). Of the 53 patients whose data were analyzed, 22 were in the United States, 22 in Europe or Canada, and 9 in Japan. At baseline, 30 patients (57%) were receiving mechanical ventilation and 4 (8%) were receiving extracorporeal membrane oxygenation. During a median follow-up of 18 days, 36 patients (68%) had an improvement in oxygen-support class, including 17 of 30 patients (57%) receiving mechanical ventilation who were extubated. A total of 25 patients (47%) were discharged, and 7 patients (13%) died; mortality was 18% (6 of 34) among patients receiving invasive ventilation and 5% (1 of 19) among those not receiving invasive ventilation. Conclusions In this cohort of patients hospitalized for severe Covid-19 who were treated with compassionate-use remdesivir, clinical improvement was observed in 36 of 53 patients (68%). Measurement of efficacy will require ongoing randomized, placebo-controlled trials of remdesivir therapy. (Funded by Gilead Sciences.)