A Phase II Study on the Use of Convalescent Plasma for the Treatment of Severe COVID-19- A Propensity Score-Matched Control Analysis.

A Phase II Study on the Use of Convalescent Plasma for the Treatment of Severe COVID-19- A Propensity Score-Matched Control Analysis.
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DOI:
10.3390/microorganisms9040806
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发表时间:
2021-04-11
期刊:
影响因子:
4.5
通讯作者:
Dimopoulos MA
Dimopoulos MA
中科院分区:
生物学3区
文献类型:
--
作者:
Pappa V;Bouchla A;Terpos E;Thomopoulos TP;Rosati M;Stellas D;Antoniadou A;Mentis A;Papageorgiou SG;Politou M;Kotanidou A;Kalomenidis I;Poulakou G;Jahaj E;Korompoki E;Grigoropoulou S;Hu X;Bear J;Karaliota S;Burns R;Pagoni M;Trontzas I;Grouzi E;Labropoulou S;Stamoulis K;Bamias A;Tsiodras S;Felber BK;Pavlakis GN;Dimopoulos MA

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COVID-19是一种全球性大流行病,发病率和死亡率均有所上升。恢复期血浆(CP)输注是一种具有潜在治疗益处的策略。我们进行了一项多中心II期研究,以评估CP在4级或以上COVID-19患者中的疗效和安全性。为了评价CP的疗效,采用匹配倾向评分分析,将干预组(n = 59)与对照组(n = 59)进行比较。60例患者在症状发作后中位7天内接受CP治疗。在中位随访28.5天期间,56/60例患者完全康复,1例患者仍留在ICU。CP组的死亡率为3.4%,对照组为13.6%。通过多变量分析,CP接受者的死亡风险显著降低[HR:0.04(95% CI:0.004-0.36),p:0.005],Kaplan-Meir分析显示总生存率显著提高(p < 0.001),拔管概率增加[OR:30.3(95% CI:2.64-348.9),p:0.006]。CP中较高水平的抗体与死亡风险显著降低独立相关。CP输注是安全的,只有1例3级不良事件(AE),很容易解决。早期使用CP可能是重度COVID-19患者的安全有效治疗(试验编号NCT 04408209)。
COVID-19 is a global pandemic associated with increased morbidity and mortality. Convalescent plasma (CP) infusion is a strategy of potential therapeutic benefit. We conducted a multicenter phase II study to evaluate the efficacy and safety of CP in patients with COVID-19, grade 4 or higher. To evaluate the efficacy of CP, a matched propensity score analysis was used comparing the intervention (n = 59) to a control group (n = 59). Sixty patients received CP within a median time of 7 days from symptom onset. During a median follow-up of 28.5 days, 56/60 patients fully recovered and 1 patient remained in the ICU. The death rate in the CP group was 3.4% vs. 13.6% in the control group. By multivariate analysis, CP recipients demonstrated a significantly reduced risk of death [HR: 0.04 (95% CI: 0.004–0.36), p: 0.005], significantly better overall survival by Kaplan–Meir analysis (p < 0.001), and increased probability of extubation [OR: 30.3 (95% CI: 2.64–348.9), p: 0.006]. Higher levels of antibodies in the CP were independently associated with significantly reduced risk of death. CP infusion was safe with only one grade 3 adverse event (AE), which easily resolved. CP used early may be a safe and effective treatment for patients with severe COVID-19 (trial number NCT04408209).
严重的Covid-19患者急性呼吸窘迫综合征患者的康复血浆疗法的功效和安全性。
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