From Cedars-Sinai Medical Center, Los Angeles (J.G.), El Camino Hospital, Mountain View (D.S., D. Chelliah), Sutter Santa Rosa Regional Hospital, Santa Rosa (G.G.), Regional Medical Center (A.S., J.R.) and Good Samaritan Hospital (S.M.), San Jose, John Muir Health, Walnut Creek (J.B.), UC Davis Health, Sacramento (S.H.C.), NorthBay Medical Center, Fairfield (S.I.), and Gilead Sciences, Foster City (A.O.O., A.D., Y.Z., L.Z., A. Chokkalingam, E.E., L. Telep, L. Timbs, I.H., S.S., H.C., S.K.T., L.W., P.D., R.M., A.G., R.P.M., D.M.B.) - all in California; the National Center for Global Health and Medicine, Tokyo (N.O.), Tokyo Bay Urayasu Ichikawa Medical Center, Urayasu City (R.O.), Hiratsuka City Hospital, Hiratsuka (K.Y.), Yokohama City University Hospital, Yokohama (H.K.), Gunma University Hospital, Gunma (T.M.), and Tosei General Hospital, Seto (Y.M.) - all in Japan; Providence Regional Medical Center Everett, Everett (G.D.), and University of Washington Medical Center-Northwest (M.L.G.) and Virginia Mason Medical Center (S. Chihara), Seattle - all in Washington; Fondazione IRCCS Policlinico San Matteo, Pavia (E.A.), IRCCS, San Raffaele Scientific Institute (A. Castagna) and Azienda Socio Sanitaria Territoriale Spedali (ASST) Santi Paolo e Carlo, Department of Health Services, University of Milan (A.D.M.), Milan, National Institute for Infectious Diseases, IRCCS, L. Spallanzani, Rome (E.N.), Università degli Study of Brescia, ASST Civili di Brescia, Brescia (E.Q.-R.), San Gerardo Hospital, ASST Monza, University of Milan-Bicocca, Monza (G.L.), and Azienda Unite Sanitarie Locali-IRCCS, Reggio Emilia (M.M.) - all in Italy; Universitätsklinikum Düsseldorf, Düsseldorf, Germany (T. Feldt); Université de Paris, Infection, Antimicrobiens, Modélisation, Evolution (IAME), INSERM, and Assistance Publique-Hôpitaux de Paris, Department of Infectious Diseases, Bichat Hospital, Paris (F.-X.L.), Centre Hospitalier Régional et Universitaire de Brest-La Cavale Blanche, Brest (E.L.), and Division of Infectious Diseases and Tropical Medicine, University Hospital of Bordeaux, Bordeaux (D.N.) - all in France; St. Alexius Medical Center, Hoffman Estates, IL (S.A.); Mackenzie Health, Richmond Hill, ON, Canada (D. Chen); Columbia University Irving Medical Center, New York (J.C.); Hospital Universitario La Paz-Carlos III, Instituto de Investigación Hospital Universitario La Paz, Madrid (M.M.-R.); Bernhoven Hospital, Uden, the Netherlands (E.V.); Kaiser Franz Josef Hospital, Vienna (A.Z.); the U.S. Public Health Service Commissioned Corps, Washington, DC (R.C.); and Miriam Hospital, Providence, RI (T. Flanigan).
N Engl J Med. 2020 Jun 11;382(24):2327-2336. doi: 10.1056/NEJMoa2007016. Epub 2020 Apr 10.
Remdesivir, a nucleotide analogue prodrug that inhibits viral RNA polymerases, has shown in vitro activity against SARS-CoV-2.
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.
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.
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.).
瑞德西韦是一种核苷酸类似物前药，可抑制病毒 RNA 聚合酶，在体外对 SARS-CoV-2 表现出活性。
我们在同情用药的基础上向因感染 SARS-CoV-2 而患 COVID-19 的住院患者提供瑞德西韦。这些患者是确诊的 SARS-CoV-2 感染者，在呼吸环境空气时血氧饱和度低于 94%，或正在接受氧疗支持。患者接受为期 10 天的瑞德西韦治疗，第 1 天静脉注射 200mg，随后 9 天每天 100mg。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 1 天后续临床数据的患者的资料。
在至少接受一剂瑞德西韦的 61 例患者中，有 8 例的数据无法分析（包括 7 例无治疗后数据和 1 例用药错误）。在可分析数据的 53 例患者中，22 例来自美国，22 例来自欧洲或加拿大，9 例来自日本。在基线时，30 例（57%）患者正在接受机械通气，4 例（8%）患者正在接受体外膜肺氧合。在中位随访 18 天期间，36 例（68%）患者的氧支持分级改善，包括 30 例接受机械通气患者中的 17 例（57%）拔管。共有 25 例（47%）患者出院，7 例（13%）死亡；接受有创通气的患者死亡率为 18%（6/34），未接受有创通气的患者死亡率为 5%（1/19）。
在这项因 COVID-19 住院且接受同情用药瑞德西韦治疗的重度患者队列中，53 例患者中有 36 例（68%）临床改善。瑞德西韦治疗的疗效需要正在进行的随机、安慰剂对照试验来衡量。（由吉利德科学公司资助）。
