Early High-Titer Plasma Therapy to Prevent Severe Covid-19 in Older Adults

被引:637
作者
Libster, R. [1 ,2 ]
Marc, G. Perez [2 ,17 ]
Wappner, D. [2 ,3 ]
Coviello, S. [1 ,2 ]
Bianchi, A. [1 ,2 ]
Braem, V [2 ,17 ]
Esteban, I [1 ]
Caballero, M. T. [1 ,4 ]
Wood, C. [1 ,17 ]
Berrueta, M. [7 ]
Rondan, A. [5 ]
Lescano, G. [5 ]
Cruz, P. [6 ]
Ritou, Y. [18 ]
Vina, V. Fernandez [8 ]
Paggi, D. Alvarez [1 ,4 ]
Esperante, S. [1 ,4 ]
Ferreti, A. [1 ]
Ofman, G. [1 ,19 ]
Ciganda, A. [7 ]
Rodriguez, R. [7 ]
Lantos, J. [3 ]
Valentini, R. [9 ]
Itcovici, N. [17 ]
Hintze, A. [17 ]
Oyarvide, M. L. [17 ]
Etchegaray, C. [17 ]
Neira, A. [17 ]
Name, I [17 ]
Alfonso, J. [17 ]
Castelo, R. Lopez [17 ]
Caruso, G. [17 ]
Rapelius, S. [17 ]
Alvez, F. [10 ]
Etchenique, F. [3 ]
Dimase, F. [17 ]
Alvarez, D. [17 ]
Aranda, S. S. [1 ,2 ]
Yanotti, C. Sanchez [1 ]
De Luca, J. [1 ]
Baglivo, S. Jares [1 ]
Laudanno, S. [1 ]
Nowogrodzki, F. [1 ]
Larrea, R. [11 ]
Silveyra, M. [12 ]
Leberzstein, G. [13 ]
Debonis, A. [14 ]
Molinos, J. [3 ]
Gonzalez, M. [15 ]
Perez, E. [16 ]
机构
[1] Fdn INFANT, Gavilan 94, RA-1406 Buenos Aires, DF, Argentina
[2] iTrials, Buenos Aires, DF, Argentina
[3] Swiss Med Grp, Buenos Aires, DF, Argentina
[4] Natl Sci & Tech Res Council, Buenos Aires, DF, Argentina
[5] Hosp Dr Carlos Bocalandro, Buenos Aires, DF, Argentina
[6] Ctr Gallego, Buenos Aires, DF, Argentina
[7] Inst Efectividad Clin & Sanitaria, Buenos Aires, DF, Argentina
[8] Hosp Simplemente Evita, Buenos Aires, DF, Argentina
[9] CEMIC, Buenos Aires, DF, Argentina
[10] Fdn Hematol Sarmiento, Buenos Aires, DF, Argentina
[11] Hosp Municipal San Isidro, Buenos Aires, DF, Argentina
[12] Sanatorio Anchorena Recoleta, Buenos Aires, DF, Argentina
[13] Sanatorio Sagrad Corazon Obra Social Empleados Co, Buenos Aires, DF, Argentina
[14] Minist Salud Prov Buenos Aires, Buenos Aires, DF, Argentina
[15] Sanatorio Finochietto, Buenos Aires, DF, Argentina
[16] Programa Atenc Med Integral, Buenos Aires, DF, Argentina
[17] Hosp Mil Cent, Buenos Aires, DF, Argentina
[18] Hosp San Juan Dios, Buenos Aires, DF, Argentina
[19] Univ Oklahoma, Norman, OK 73019 USA
[20] WHO, United Nat Dev Program, United Nat Populat Fund,Dept Sexual & Reprod Hlth, United Nat Childrens Fund,World Bank Special Prog, Geneva, Switzerland
关键词
D O I
10.1056/NEJMoa2033700
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND Therapies to interrupt the progression of early coronavirus disease 2019 (Covid-19) remain elusive. Among them, convalescent plasma administered to hospitalized patients has been unsuccessful, perhaps because antibodies should be administered earlier in the course of illness. METHODS We conducted a randomized, double-blind, placebo-controlled trial of convalescent plasma with high IgG titers against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in older adult patients within 72 hours after the onset of mild Covid-19 symptoms. The primary end point was severe respiratory disease, defined as a respiratory rate of 30 breaths per minute or more, an oxygen saturation of less than 93% while the patient was breathing ambient air, or both. The trial was stopped early at 76% of its projected sample size because cases of Covid-19 in the trial region decreased considerably and steady enrollment of trial patients became virtually impossible. RESULTS A total of 160 patients underwent randomization. In the intention-to-treat population, severe respiratory disease developed in 13 of 80 patients (16%) who received convalescent plasma and 25 of 80 patients (31%) who received placebo (relative risk, 0.52; 95% confidence interval [CI], 0.29 to 0.94; P = 0.03), with a relative risk reduction of 48%. A modified intention-to-treat analysis that excluded 6 patients who had a primary end-point event before infusion of convalescent plasma or placebo showed a larger effect size (relative risk, 0.40; 95% CI, 0.20 to 0.81). No solicited adverse events were observed. CONCLUSIONS Early administration of high-titer convalescent plasma against SARS-CoV-2 to mildly ill infected older adults reduced the progression of Covid-19.
引用
收藏
页码:610 / 618
页数:9
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