From the Division of Nephrology, Department of Medicine, University of Michigan, Ann Arbor, MI.
Division of Acute Care Surgery, Department of Surgery, University of Michigan, Ann Arbor, MI.
ASAIO J. 2020 Nov/Dec;66(10):1079-1083. doi: 10.1097/MAT.0000000000001239.
Observational evidence suggests that excessive inflammation with cytokine storm may play a critical role in development of acute respiratory distress syndrome (ARDS) in COVID-19. We report the emergency use of immunomodulatory therapy utilizing an extracorporeal selective cytopheretic device (SCD) in two patients with elevated serum interleukin (IL)-6 levels and refractory COVID-19 ARDS requiring extracorporeal membrane oxygenation (ECMO). The two patients were selected based on clinical criteria and elevated levels of IL-6 (>100 pg/ml) as a biomarker of inflammation. Once identified, emergency/expanded use permission for SCD treatment was obtained and patient consented. Six COVID-19 patients (four on ECMO) with severe ARDS were also screened with IL-6 levels less than 100 pg/ml and were not treated with SCD. The two enrolled patients' PaO2/FiO2 ratios increased from 55 and 58 to 200 and 192 at 52 and 50 hours, respectively. Inflammatory indices also declined with IL-6 falling from 231 and 598 pg/ml to 3.32 and 116 pg/ml, respectively. IL-6/IL-10 ratios also decreased from 11.8 and 18 to 0.7 and 0.62, respectively. The two patients were successfully weaned off ECMO after 17 and 16 days of SCD therapy, respectively. The results observed with SCD therapy on these two critically ill COVID-19 patients with severe ARDS and elevated IL-6 is encouraging. A multicenter clinical trial is underway with an FDA-approved investigational device exemption to evaluate the potential of SCD therapy to effectively treat COVID-19 intensive care unit patients.
观察性证据表明，细胞因子风暴引起的过度炎症可能在 COVID-19 急性呼吸窘迫综合征（ARDS）的发展中起关键作用。我们报告了在两名血清白细胞介素（IL）-6 水平升高且需要体外膜氧合（ECMO）的难治性 COVID-19 ARDS 患者中使用免疫调节治疗的紧急情况，该治疗利用了体外选择性细胞分离设备（SCD）。这两名患者是根据临床标准和升高的 IL-6 水平（>100 pg/ml）选择的，后者是炎症的生物标志物。一旦确定，就获得了 SCD 治疗的紧急/扩展使用许可，并获得了患者的同意。还对六名 COVID-19 患者（四名在 ECMO 上）进行了 IL-6 水平低于 100 pg/ml 的筛选，并且未用 SCD 治疗。两名入组患者的 PaO2/FiO2 比值分别从 55 和 58 增加到 52 和 50 小时的 200 和 192。炎症指数也下降了，IL-6 分别从 231 和 598 pg/ml 下降到 3.32 和 116 pg/ml。IL-6/IL-10 比值也分别从 11.8 和 18 下降到 0.7 和 0.62。两名患者在接受 SCD 治疗 17 和 16 天后分别成功脱离 ECMO。SCD 治疗对这两名患有严重 ARDS 和升高的 IL-6 的危重症 COVID-19 患者的疗效令人鼓舞。一项多中心临床试验正在进行中，该试验获得了 FDA 批准的研究性器械豁免，以评估 SCD 治疗有效治疗 COVID-19 重症监护病房患者的潜力。
