Supplementary Material for: THE ROLE OF IMMUNOMODULATORY THERAPY WITH OXIRIS IN COVID 19 WITH RENAL FAILURE AND IMMUNE DYSFUNCTION.

INTRODUCTION: The main objective of this study is to evaluate the impact of hemoadsorption on the elimination of inflammatory mediators.
METHODS: A prospective, bicenter, observational cohort study was conducted between March 2020 and February 2022 to explore the immunomodulatory response, demographic and clinical characteristics of individuals with COVID-19 admitted to the ICU with severe acute respiratory failure and in need of CRRT with Oxiris® with or without AKI.
RESULTS: 64 patients were analyzed. Statistically significant differences were observed between exposed and unexposed groups, regarding levels of D-dimer -15614 (24848.9) vs -4136.5(9913.47) (p .031, d:1.59, 95% CI -21830, -1126). An increase in PCT was observed 0.47(2.08) vs -0.75(2.3) (p .044 95% CI 0.03,2.44). No differences were found in a decrease in CRP -4.21(7.29) vs -1.6(9.02) (p .22) nor in the rest of inflammatory parameters fibrinogen, IL-6, ferritin, lymphocytes, and neutrophils. Subgroup analysis in patients exposed to therapy also showed a significant decrease in D-Dimer of 55% from baseline; 6000 (1984.5-277750) pre-therapy vs 2700 (2119.5-6145) (95% CI -23000, -2489) post-therapy with a strong effect size (p .001, d:0.65).
CONCLUSION: The hemoadsorptive therapy in COVID 19 was associated with a significant decrease in D-dimer parameters without showing decreases in the rest of the clinical, inflammatory parameters and severity scales analyzed.

引言：本研究的主要目的是评估血液吸附（hemoadsorption）疗法对炎症介质的清除效果。
方法：本研究为前瞻性、双中心观察性队列研究，于2020年3月至2022年2月期间开展，旨在探究因新型冠状病毒肺炎（COVID-19）入住重症监护病房（Intensive Care Unit, ICU）、出现重症急性呼吸衰竭且需接受连续性肾脏替代治疗（Continuous Renal Replacement Therapy, CRRT）联合Oxiris®装置，伴或不伴急性肾损伤（Acute Kidney Injury, AKI）的患者的免疫调节应答、人口学特征及临床特征。
结果：本研究共纳入64例患者进行分析。暴露组与非暴露组在D-二聚体（D-dimer）水平上存在统计学显著性差异：暴露组为-15614 (24848.9)，非暴露组为-4136.5 (9913.47)（p=0.031，d=1.59，95%置信区间（CI）：-21830，-1126）。降钙素原（PCT）水平亦出现显著变化：暴露组为0.47 (2.08)，非暴露组为-0.75 (2.3)（p=0.044，95%CI：0.03，2.44）。C反应蛋白（CRP）水平变化无显著组间差异：暴露组为-4.21 (7.29)，非暴露组为-1.6 (9.02)（p=0.22）；其余炎症相关指标，包括纤维蛋白原、白细胞介素-6（IL-6）、铁蛋白、淋巴细胞及中性粒细胞计数，均未观察到组间显著差异。对接受治疗的暴露组患者进行亚组分析显示，D-二聚体水平较基线显著下降55%：治疗前为6000 (1984.5-277750)，治疗后为2700 (2119.5-6145)（95%CI：-23000，-2489），效应量较强（p=0.001，d=0.65）。
结论：针对新型冠状病毒肺炎患者的血液吸附疗法，可显著降低D-二聚体水平，但未观察到其余分析的临床、炎症指标及严重程度评分出现显著下降。