A randomized controlled study of convalescent plasma for individuals hospitalized with COVID-19 pneumonia
A randomized controlled study of convalescent plasma for individuals hospitalized with COVID-19 pneumonia
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DOI：
10.1172/jci155114
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发表时间：
2021-12-15
影响因子：
15.9
通讯作者：
Tebas, Pablo
中科院分区：
文献类型：
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作者：
Bar, Katharine J.;Shaw, Pamela A.;Tebas, Pablo
背景。基于抗体的 COVID-19 策略在预防和治疗早期疾病方面显示出前景。 COVID-19 恢复期血浆 (CCP) 已被广泛使用，但支持其对住院肺炎患者有益的随机试验结果有限。在这里，我们评估了 CCP 对患有 COVID-19 肺炎的重症住院成人的疗效。方法。我们对 80 名因 COVID-19 肺炎住院的成年人进行了一项随机对照试验 (PennCCP2)，对最多 2 个单位的本地 CCP 加标准护理与单独标准护理进行了比较。主要疗效终点是临床严重程度评分的比较。主要次要结局包括 14 天和 28 天死亡率、14 天和 28 天最大 8 分 WHO 序数评分 (WHO8) 评分、补充氧合或机械通气持续时间、呼吸道 SARS-CoV-2 RNA 和抗 SARS-CoV-2 抗体。结果。 80 名确诊为 COVID-19 肺炎的住院成人在出现症状中位第 6 天和住院第 1 天时入组； 60% 的抗 SARS-CoV-2 抗体血清呈阴性。参与者的合并症中位数为 3 种，包括严重 COVID-19 和免疫抑制的危险因素。 CCP 治疗是安全的，并且在临床严重程度评分（中位数 [MED] 和四分位数范围 [IQR] 10 [5.5-30] 与 7 [2.75-12.25]，P = 0.037）和 28 天死亡率（n = 10, 26% vs. n = 2, 5%；P = 0.013）方面具有显着益处。所有其他预先指定的结果指标都表明 CCP 受益的证据微弱。结论。大多数血清阴性参与者在住院早期服用两份本地采购的 CCP，可显着降低临床严重程度评分和 28 天死亡率。结果表明，CCP 可能会使特定人群受益，特别是那些患有合并症且接受早期治疗的人群。试用注册。 ClinicalTrials.gov NCT04397757。资金。宾夕法尼亚大学。
BACKGROUND. Antibody-based strategies for COVID-19 have shown promise in prevention and treatment of early disease. COVID-19 convalescent plasma (CCP) has been widely used but results from randomized trials supporting its benefit in hospitalized patients with pneumonia are limited. Here, we assess the efficacy of CCP in severely ill, hospitalized adults with COVID-19 pneumonia. METHODS. We performed a randomized control trial (PennCCP2), with 80 adults hospitalized with COVID-19 pneumonia, comparing up to 2 units of locally sourced CCP plus standard care versus standard care alone. The primary efficacy endpoint was comparison of a clinical severity score. Key secondary outcomes include 14-and 28-day mortality, 14-and 28-day maximum 8-point WHO ordinal score (WHO8) score, duration of supplemental oxygenation or mechanical ventilation, respiratory SARS-CoV-2 RNA, and anti-SARS-CoV-2 antibodies. RESULTS. Eighty hospitalized adults with confirmed COVID-19 pneumonia were enrolled at median day 6 of symptoms and day 1 of hospitalization; 60% were anti-SARS-CoV-2 antibody seronegative. Participants had a median of 3 comorbidities, including risk factors for severe COVID-19 and immunosuppression. CCP treatment was safe and conferred significant benefit by clinical severity score (median [MED] and interquartile range [IQR] 10 [5.5-30] vs. 7 [2.75-12.25], P = 0.037) and 28-day mortality (n = 10, 26% vs. n = 2, 5%; P = 0.013). All other prespecified outcome measures showed weak evidence toward benefit of CCP. CONCLUSION. Two units of locally sourced CCP administered early in hospitalization to majority seronegative participants conferred a significant benefit in clinical severity score and 28-day mortality. Results suggest CCP may benefit select populations, especially those with comorbidities who are treated early. TRIAL REGISTRATION. ClinicalTrials.gov NCT04397757. FUNDING. University of Pennsylvania.