Department of Infectious Diseases, Urmia University of Medical Sciences, Urmia, Iran.
Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
BMC Infect Dis. 2020 Oct 21;20(1):786. doi: 10.1186/s12879-020-05507-4.
Coronavirus disease 2019 (COVID-19) has infected people in many countries worldwide. Discovering an effective treatment for this disease, particularly in severe cases, has become the subject of intense scientific investigation. Therefore, the objective of this study was to evaluate the efficacy of intravenous immunoglobulin (IVIg) in patients with severe COVID-19 infection.
This study was conducted as a randomized placebo-controlled double-blind clinical trial. Fifty-nine patients with severe COVID-19 infection who did not respond to initial treatments were randomly assigned into two groups. One group received IVIg (human)-four vials daily for 3 days (in addition to initial treatment), while the other group received a placebo. Patients' demographic, clinical, and select laboratory test results, as well as the occurrence of in-hospital mortality, were recorded.
Among total study subjects, 30 patients received IVIg and 29 patients received a placebo. Demographics, clinical characteristics, and laboratory tests were not statistically different (P > 0.05) between the two groups. The in-hospital mortality rate was significantly lower in the IVIg group compared to the control group (6 [20.0%] vs. 14 [48.3%], respectively; P = 0.022). Multivariate regression analysis demonstrated that administration of IVIg did indeed have a significant impact on mortality rate (aOR = 0.003 [95% CI: 0.001-0.815]; P = 0.042).
Our study demonstrated that the administration of IVIg in patients with severe COVID-19 infection who did not respond to initial treatment could improve their clinical outcome and significantly reduce mortality rate. Further multicenter studies with larger sample sizes are nonetheless required to confirm the appropriateness of this medication as a standard treatment.
A study protocol was registered at the Iranian Registry of Clinical Trials ( www.IRCT.ir ), number IRCT20200501047259N1 . It was registered retrospectively on May 17th, 2020.
新型冠状病毒病（COVID-19）已在世界许多国家感染了人们。发现对此病的有效治疗方法，特别是在严重病例中，已成为激烈科学研究的主题。因此，本研究的目的是评估静脉注射免疫球蛋白（IVIg）在重症 COVID-19 感染患者中的疗效。
本研究是一项随机安慰剂对照双盲临床试验。59 例对初始治疗无反应的重症 COVID-19 感染患者被随机分为两组。一组患者接受 IVIg（人）-每天四瓶，连续 3 天（除初始治疗外），另一组患者接受安慰剂。记录患者的人口统计学、临床和选择实验室检查结果，以及住院死亡率的发生情况。
在所有研究对象中，30 例患者接受 IVIg 治疗，29 例患者接受安慰剂治疗。两组患者的人口统计学、临床特征和实验室检查无统计学差异（P>0.05）。IVIg 组的住院死亡率明显低于对照组（分别为 6 [20.0%]和 14 [48.3%]；P=0.022）。多变量回归分析表明，IVIg 的使用确实对死亡率有显著影响（调整后的 OR=0.003 [95%CI：0.001-0.815]；P=0.042）。
我们的研究表明，在对初始治疗无反应的重症 COVID-19 感染患者中使用 IVIg 可改善其临床结局，并显著降低死亡率。然而，仍需要更大样本量的多中心研究来证实该药物作为标准治疗的适宜性。
研究方案已在伊朗临床试验注册中心（www.IRCT.ir）注册，注册号为 IRCT20200501047259N1。它于 2020 年 5 月 17 日回溯性注册。
