The aim of this randomized, controlled trial is to determine whether anti-SARS-CoV-2 hyperimmune globulin protects against severe COVID-19 in severely immunocompromised, hospitalized, COVID-19 patients. Patients were randomly assigned to receive anti-SARS-CoV-2 hyperimmune globulin (COVIG) or intravenous immunoglobulin without SARS-CoV-2 antibodies. Severe COVID-19 was observed in two out of ten (20%) patients treated with COVIG compared to seven out of eight (88%) in the IVIG control group (p = 0.015, Fisher’s exact test). COVIG may be a valuable treatment in severely immunocompromised, hospitalized, COVID-19 patients and should be considered when no monoclonal antibody therapies are available. The trial was registered at www.trialregister.nl (#NL9436).

中文翻译：

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用于因 COVID-19 住院的严重免疫功能低下患者的高免疫球蛋白：一项随机对照试验

这项随机对照试验的目的是确定抗 SARS-CoV-2 超免疫球蛋白是否能在严重免疫功能低下的住院 COVID-19 患者中预防重症 COVID-19。患者被随机分配接受抗 SARS-CoV-2 超免疫球蛋白 (COVIG) 或不含 SARS-CoV-2 抗体的静脉注射免疫球蛋白。与 IVIG 对照组八分之七 (88%) 相比，接受 COVIG 治疗的患者中有十分之二 (20%) 出现重度 COVID-19（p = 0.015，Fisher 精确检验）。COVIG 可能是严重免疫功能低下的住院 COVID-19 患者的一种有价值的治疗方法，在没有可用的单克隆抗体疗法时应予以考虑。该试验已在 www.trialregister.nl (#NL9436) 上注册。