Compassionate Use of Remdesivir for Patients with Severe Covid-19

被引:1820
作者
Grein, J. [1 ]
Ohmagari, N. [10 ]
Shin, D. [2 ]
Diaz, G. [16 ]
Asperges, E. [19 ]
Castagna, A. [20 ]
Feldt, T. [26 ]
Green, G. [3 ]
Green, M. L. [17 ]
Lescure, F-X [27 ,28 ]
Nicastri, E. [22 ]
Oda, R. [11 ]
Yo, K. [12 ]
Quiros-Roldan, E. [23 ]
Studemeister, A. [4 ]
Redinski, J. [4 ]
Ahmed, S. [31 ]
Bernett, J. [6 ]
Chelliah, D. [2 ]
Chen, D. [32 ]
Chihara, S. [18 ]
Cohen, S. H. [7 ]
Cunningham, J. [33 ]
Monforte, A. DArminio [21 ]
Ismail, S. [8 ]
Kato, H. [13 ]
Lapadula, G. [24 ]
L'Her, E. [29 ]
Maeno, T. [14 ]
Majumder, S. [5 ]
Massari, M. [25 ]
Mora-Rillo, M. [34 ]
Mutoh, Y. [15 ]
Nguyen, D. [30 ]
Verweij, E. [35 ]
Zoufaly, A. [36 ]
Osinusi, A. O. [9 ]
DeZure, A. [9 ]
Zhao, Y. [9 ]
Zhong, L. [9 ]
Chokkalingam, A. [9 ]
Elboudwarej, E. [9 ]
Telep, L. [9 ]
Timbs, L. [9 ]
Henne, I [9 ]
Sellers, S. [9 ]
Cao, H. [9 ]
Tan, S. K. [9 ]
Winterbourne, L. [9 ]
Desai, P. [9 ]
机构
[1] Cedars Sinai Med Ctr, Los Angeles, CA 90048 USA
[2] El Camino Hosp, Mountain View, CA USA
[3] Sutter Santa Rosa Reg Hosp, Santa Rosa, CA USA
[4] Reg Med Ctr, San Jose, CA USA
[5] Good Samaritan Hosp, San Jose, CA USA
[6] John Muir Hlth, Walnut Creek, CA USA
[7] UC Davis Hlth, Sacramento, CA USA
[8] NorthBay Med Ctr, Fairfield, CA USA
[9] Gilead Sci, 333 Lakeside Dr, Foster City, CA 94404 USA
[10] Natl Ctr Global Hlth & Med, Tokyo, Japan
[11] Tokyo Bay Urayasu Ichikawa Med Ctr, Urayasu, Japan
[12] Hiratsuka City Hosp, Hiratsuka, Kanagawa, Japan
[13] Yokohama City Univ Med, Yokohama, Kanagawa, Japan
[14] Gunma Univ Hosp, Gunma, Japan
[15] Tosei Gen Hosp, Seto, Japan
[16] Providence Reg Med Ctr Everett, Everett, WA USA
[17] Univ Washington, Med Ctr Northwest, Seattle, WA 98195 USA
[18] Virginia Mason Med Ctr, Seattle, WA 98101 USA
[19] Fdn IRCCS Policlin San Mateo, Pavia, Italy
[20] Ist Sci San Raffaele, IRCCS, Milan, Italy
[21] Univ Milan, Dept Hlth Serv, Azienda Socio Sanit Terr Spedali ASST Santi Paolo, Milan, Italy
[22] IRCCS L Spallanzani, Natl Inst Infect Dis, Rome, Italy
[23] Univ Brescia, ASST Civili Brescia, Brescia, Italy
[24] Univ Milano Bicocca, San Gerardo Hosp, ASST Monza, Monza, Italy
[25] Azienda Unite Sanit Locali IRCCS, Reggio Emilia, Italy
[26] Univ Klinikum Dusseldorf, Dusseldorf, Germany
[27] Univ Paris, Infect Antimicrobiens Modelisat Evolut IAME, INSERM, Paris, France
[28] Hop Xavier Bichat, AP HP, Dept Infect Dis, Paris, France
[29] Ctr Hosp Reg & Univ Brest La Cavale Blanche, Brest, France
[30] Univ Hosp Bordeaux, Div Infect Dis & Trop Med, Bordeaux, France
[31] St Alexius Med Ctr, Hoffman Estates, IL USA
[32] Mackenzie Hlth, Richmond Hill, ON, Canada
[33] Columbia Univ, Irving Med Ctr, New York, NY USA
[34] Hosp Univ La Paz Carlos III, Inst Invest Hosp Univ La Paz, Madrid, Spain
[35] Bernhoven Hosp, Uden, Netherlands
[36] Kaiser Franz Josef Hosp, Vienna, Austria
[37] US Publ Hlth Serv Commissioned Corps, Washington, DC USA
[38] Miriam Hosp, Providence, RI 02906 USA
基金
欧盟地平线“2020”;
关键词
CORONAVIRUS;
D O I
10.1056/NEJMoa2007016
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.)
引用
收藏
页码:2327 / 2336
页数:10
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