A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia.
A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia.
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DOI：
10.1056/nejmoa2031304
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发表时间：
2021-02-18
期刊：
影响因子：
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通讯作者：
PlasmAr Study Group
中科院分区：
文献类型：
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作者：
Simonovich VA;Burgos Pratx LD;Scibona P;Beruto MV;Vallone MG;Vázquez C;Savoy N;Giunta DH;Pérez LG;Sánchez MDL;Gamarnik AV;Ojeda DS;Santoro DM;Camino PJ;Antelo S;Rainero K;Vidiella GP;Miyazaki EA;Cornistein W;Trabadelo OA;Ross FM;Spotti M;Funtowicz G;Scordo WE;Losso MH;Ferniot I;Pardo PE;Rodriguez E;Rucci P;Pasquali J;Fuentes NA;Esperatti M;Speroni GA;Nannini EC;Matteaccio A;Michelangelo HG;Follmann D;Lane HC;Belloso WH;PlasmAr Study Group
恢复期血浆经常用于新型冠状病毒肺炎患者，据报道，恢复期血浆主要是基于观察数据，可改善临床结局。从充分把握度的随机对照试验中获得的数据很少。我们以2：1的比例将患有严重新冠肺炎的住院成人患者随机分配接受恢复期血浆或安慰剂。主要结果是患者在干预后30天的临床状态，以从完全恢复到死亡的六点顺序量表进行测量。共有228名患者被分配接受恢复期血浆，105名患者接受安慰剂。从症状发作到入组试验的中位时间为8天（四分位距，5 - 10），低氧血症是入组的最常见严重程度标准。输注的恢复期血浆总SARS-CoV-2抗体的中位滴度为1：3200（四分位数范围，1：800至1：3200）。无患者失访。在第30天，根据顺序量表，恢复期血浆组和安慰剂组在临床结局分布方面没有显著差异（比值比，0.83（95%置信区间[CI]，0.52至1.35; P=0.46）。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（95%CI，-7.8至6.8）。在干预后第2天，恢复期血浆组的总SARS-CoV-2抗体滴度倾向于更高。两组不良事件和严重不良事件相似。在接受恢复期血浆治疗的患者和接受安慰剂治疗的患者之间，未观察到临床状态或总体死亡率的显著差异。（PlasmAr ClinicalTrials.gov编号，NCT 04383535。）
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. 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. 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. No significant differences were observed in clinical status or overall mortality between patients treated with convalescent plasma and those who received placebo. (PlasmAr ClinicalTrials.gov number, NCT04383535.)