帕博利珠单抗联合托珠单抗治疗 COVID-19（COPERNICO）高危住院患者：一项随机概念验证 II 期研究。
Pembrolizumab in combination with tocilizumab in high-risk hospitalized patients with COVID-19 (COPERNICO): A randomized proof-of-concept phase II study.
机构信息
Hospital Universitario Ramón y Cajal; Instituto de Investigación Biomédica del Hospital y Ramón y Cajal, Madrid, Spain; Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Infecciones (CIBERINFEC), Madrid, Spain.
International Breast Cancer Center (IBCC), Quirónsalud Group, Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain.
出版信息
Int J Infect Dis. 2022 Oct;123:97-103. doi: 10.1016/j.ijid.2022.08.007. Epub 2022 Aug 17.
OBJECTIVES
Severe COVID-19 is associated with immune dysregulation and hyperinflammation (lymphocyte exhaustion and elevated interleukin 6. Pembrolizumab (P; immune-activating anti-programmed cell death-1 antibody) plus tocilizumab (TCZ; anti- interleukin 6 receptor antibody) might interrupt the hyperinflammation and restore cellular immunocompetence. We assessed the efficacy and safety of P + TCZ + standard of care (SOC) in high-risk, hospitalized patients with COVID-19 pneumonia without mechanical ventilation.
METHODS
Randomized, controlled, open-label, phase II trial in patients with severe SARS-CoV-2 infection to assess the hospitalization period to discharge.
RESULTS
A total of 12 patients were randomized (P + TCZ + SOC, n = 7; SOC, n = 5). Nine (75%) were males, with a median age of 68 (41-79) years. The median time to discharge for P + TCZ + SOC and SOC was 10 and 47.5 days (P = 0.03), with zero (n = 1 patient had P-related grade 5 myositis) and two COVID-19-related deaths, respectively.
CONCLUSION
The addition of P and TCZ to SOC reduced the hospitalization period, with higher and faster discharges without sequelae than SOC alone.
目的
严重的 COVID-19 与免疫失调和过度炎症（淋巴细胞耗竭和白细胞介素 6 升高）有关。派姆单抗（P；免疫激活抗程序性细胞死亡 1 抗体）联合托珠单抗（TCZ；抗白细胞介素 6 受体抗体）可能会中断过度炎症并恢复细胞免疫能力。我们评估了 P+TCZ+标准治疗（SOC）在没有机械通气的 COVID-19 肺炎高危住院患者中的疗效和安全性。
方法
这是一项在严重 SARS-CoV-2 感染患者中进行的随机、对照、开放标签、二期临床试验，评估住院期间至出院的时间。
结果
共有 12 名患者被随机分配（P+TCZ+SOC，n=7；SOC，n=5）。9 名（75%）为男性，中位年龄为 68（41-79）岁。P+TCZ+SOC 和 SOC 的中位出院时间分别为 10 和 47.5 天（P=0.03），分别有 1 名（患者发生与 P 相关的 5 级肌炎）和 2 名（与 COVID-19 相关）死亡。
结论
SOC 中加入 P 和 TCZ 可缩短住院时间，与 SOC 相比，出院更快且无后遗症。
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