阿根廷布宜诺斯艾利斯意大利医院Ventura A. Simonovich团队研究了恢复期血浆治疗Covid-19重症患者的疗效。2020年11月24日，该研究发表在《新英格兰医学杂志》上。

基于大部分观察数据，Covid-19患者经常使用恢复期血浆治疗可改善临床效果。但从足够有力的随机对照试验中可获得的数据较少。

研究组招募Covid-19重症成人住院患者，以2：1的比例随机分配，其中228位接受恢复期血浆治疗，105位接受安慰剂治疗。主要结局是干预后30天的患者临床状况，以六点序量表衡量，从完全恢复到死亡不等。参与者从症状发作到入组的中位时间为8天，低氧血症是最常见的入组严重程度标准。患者输注的恢复期血浆中总SARS-CoV-2抗体的平均滴度为1：3200，没有患者失去随访。

第30天时，恢复期血浆组与安慰剂组之间的临床结局分布无明显差异。恢复期血浆组的总死亡率为10.96％，安慰剂组为11.43％，风险差异为-0.46个百分点。干预后第2天，恢复期血浆组的SARS-CoV-2抗体滴度总体较高。两组的不良事件和严重不良事件相似。

研究结果表明，采用恢复期血浆治疗Covid-19患者，与安慰剂相比，并不能显著改善临床状况或总体死亡率。

附：英文原文

Title: A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia

Author: Ventura A. Simonovich, M.D.,, Leandro D. Burgos Pratx, M.D.,, Paula Scibona, M.D.,, María V. Beruto, M.D.,, Marcelo G. Vallone, M.D.,, Carolina Vázquez, M.D.,, Nadia Savoy, M.D.,, Diego H. Giunta, M.D., M.P.H., Ph.D.,, Lucía G. Pérez, M.D.,, Marisa del L. Sánchez, M.D.,, Andrea Vanesa Gamarnik, Ph.D.,, Diego S. Ojeda, Ph.D.,, Diego M. Santoro, M.D.,, Pablo J. Camino, M.D.,, Sebastian Antelo, M.D.,, Karina Rainero, M.D.,, Gabriela P. Vidiella, M.D.,, Erica A. Miyazaki, M.D.,, Wanda Cornistein, M.D.,, Omar A. Trabadelo, M.D.,, Fernando M. Ross, M.D.,, Mariano Spotti, M.D.,, Gabriel Funtowicz, M.D.,, Walter E. Scordo, M.D.,, Marcelo H. Losso, M.D.,, Inés Ferniot, M.D.,, Pablo E. Pardo, M.D.,, Eulalia Rodriguez, M.D.,, Pablo Rucci, M.D.,, Julieta Pasquali, M.D.,, Nora A. Fuentes, M.D.,, Mariano Esperatti, M.D., Ph.D.,, Gerardo A. Speroni, M.D.,, Esteban C. Nannini, M.D.,, Alejandra Matteaccio, M.D.,, Hernán G. Michelangelo, M.D.,, Dean Follmann, Ph.D.,, H. Clifford Lane, M.D.,, and Waldo H. Belloso, M.D.

Issue&Volume: 2020-11-24

Abstract:

BACKGROUND

Convalescent plasma is frequently administered to patients with Covid-19 and has been reported, largely on the basis of observational data, to improve clinical outcomes. Minimal data are available from adequately powered randomized, controlled trials.

METHODS

We randomly assigned hospitalized adult patients with severe Covid-19 pneumonia in a 2:1 ratio to receive convalescent plasma or placebo. The primary outcome was the patient’s clinical status 30 days after the intervention, as measured on a six-point ordinal scale ranging from total recovery to death.

RESULTS

A total of 228 patients were assigned to receive convalescent plasma and 105 to receive placebo. The median time from the onset of symptoms to enrollment in the trial was 8 days (interquartile range, 5 to 10), and hypoxemia was the most frequent severity criterion for enrollment. The infused convalescent plasma had a median titer of 1:3200 of total SARS-CoV-2 antibodies (interquartile range, 1:800 to 1:3200]. No patients were lost to follow-up. At day 30 day, no significant difference was noted between the convalescent plasma group and the placebo group in the distribution of clinical outcomes according to the ordinal scale (odds ratio, 0.83 (95% confidence interval [CI], 0.52 to 1.35; P=0.46). Overall mortality was 10.96% in the convalescent plasma group and 11.43% in the placebo group, for a risk difference of 0.46 percentage points (95% CI, 7.8 to 6.8). Total SARS-CoV-2 antibody titers tended to be higher in the convalescent plasma group at day 2 after the intervention. Adverse events and serious adverse events were similar in the two groups.

CONCLUSIONS

No significant differences were observed in clinical status or overall mortality between patients treated with convalescent plasma and those who received placebo.

DOI: 10.1056/NEJMoa2031304

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2031304