Effects of adjunct treatment with intravenous immunoglobulins on the course of severe COVID-19: results from a retrospective cohort study

To evaluate the effect of adjunct treatment with Octagam, an intravenous immunoglobulin (IVIG) product, on clinical outcomes and biomarkers in critically ill COVID-19 patients. Data from a single center was analyzed retrospectively. Patients had received preliminary standard intensive care (SIC) according to a local treatment algorithm, either alone or along with IVIG 5% at 30 g/day for 5 days. The two groups were compared regarding baseline characteristics, survival and changes in inflammation markers. Imbalance in baseline APACHE II scores was addressed by propensity score matching. Otherwise, Kaplan–Meier and multiple logistic regression models were used. Out of 93 patients, 51 had received IVIG and 42 had not. About 75% of patients were male and both groups had comparable body mass index and AB0 blood type distribution. IVIG-treated patients were younger (mean 65 ± 15 versus 71 ± 15 years, <i>p</i> = .066) and had slightly lower baseline disease scores (APACHE II: 20.6 versus 22.4, <i>p</i> = .281; SOFA: 5.0 versus 7.0, <i>p</i> = .006). Overall survival was 61% in the SIC + IVIG and 38% in the SIC only group (odds ratio: 2.2, 95% confidence interval: 0.9–5.4, <i>p</i> = .091 after controlling for baseline imbalances). IVIG significantly prolonged median survival time (68 versus 18 days, <i>p</i> = .014) and significantly reduced plasma levels of C-reactive protein (median change from baseline −71.5 versus −0.3 mg/L, <i>p</i> = .049). Clinically relevant benefits through adjunct IVIG treatment in COVID-19 need to be confirmed in a randomized, controlled trial.

本研究旨在评估静脉注射免疫球蛋白（intravenous immunoglobulin，IVIG）产品Octagam的辅助治疗对重症新型冠状病毒肺炎（COVID-19）患者临床结局与生物标志物的影响。本研究回顾性分析了单中心数据，入组患者均依据当地治疗流程接受初始标准重症监护（standard intensive care，SIC），分为单纯标准重症监护组与联合5% IVIG 30g/日、持续5日治疗组。对两组患者的基线特征、生存率及炎症标志物变化进行对比分析，针对基线APACHE II评分不均衡的问题采用倾向得分匹配法进行校正，其余分析则采用Kaplan-Meier法及多因素logistic回归模型。本研究共纳入93例患者，其中51例接受IVIG辅助治疗，42例未接受。两组患者中约75%为男性，体质量指数及AB0血型分布均无显著差异。接受IVIG治疗的患者年龄相对更轻（平均年龄：65±15岁 vs 71±15岁，*p*=0.066），基线疾病评分略低（APACHE II：20.6 vs 22.4，*p*=0.281；SOFA：5.0 vs 7.0，*p*=0.006）。标准重症监护联合IVIG组的总体生存率为61%，单纯标准重症监护组为38%；在校正基线不均衡因素后，优势比为2.2，95%置信区间为0.9~5.4（*p*=0.091）。IVIG治疗可显著延长患者的中位生存期（68天 vs 18天，*p*=0.014），并显著降低血浆C反应蛋白水平（基线至随访的中位变化量：-71.5mg/L vs -0.3mg/L，*p*=0.049）。本研究结果提示，辅助IVIG治疗对COVID-19患者存在临床获益，但该结论仍需通过随机对照试验进一步验证。