INTRODUCTION The aim of this study was to evaluate the risk of hospitalization or death in patients infected by SARS-CoV2 variants of concern (VOCs) receiving combinations of monoclonal antibodies (mAbs), bamlanivimab/etesevimab or casirivimab/imdevimab. METHODS Observational prospective study conducted in two Italian hospitals (University Hospital of Pisa and San Donato Hospital, Arezzo) including consecutive outpatients with COVID-19 who received bamlanivimab/etesevimab or casirivimab/imdevimab from March 20th to May 10th 2021. All patients were at high risk of COVID-19 progression according to FDA/AIFA recommendations. Patients were divided into two study groups according to the infecting viral strain (VOCs): Alpha and Gamma group. The primary endpoint was a composite of hospitalization or death within 30 days from mAbs infusion. A Cox regression multivariate analysis was performed to identify factors associated with the primary outcome in the overall population. RESULTS The study included 165 patients: 105 were infected by the VOC Alpha and 43 by the VOC Gamma. In the Alpha group, no differences in the primary endpoint were observed between patients treated with bamlanivimab/etesevimab or casirivimab/imdevimab. Conversely, in the Gamma group, a higher proportion of patients treated with bamlanivimab/etesevimab met the primary endpoint compared to those receiving casirivimab/imdevimab (55% vs. 17.4%, p = 0.013). On multivariate Cox-regression analysis, the Gamma variant and days from symptoms onset to mAbs infusion were factors independently associated with higher risk of hospitalization or death, while casirivimab/imdevimab was protective (HR 0.33, 95% CI 0.13-0.83, p = 0.019). CONCLUSIONS In patients infected by the SARS-CoV-2 Gamma variant, bamlanivimab/etesevimab should be used with caution because of the high risk of disease progression.

中文翻译：

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Bamlanivimab/Etesevimab 和 Casirivimab/Imdevimab 在预防进展为严重 COVID-19 方面的功效以及值得关注的变体的作用。

简介 本研究的目的是评估接受单克隆抗体 (mAb)、bamlanivimab/etesevimab 或 casirivimab/imdevimab 组合治疗的 SARS-CoV2 相关变体 (VOC) 感染患者的住院或死亡风险。方法 在两家意大利医院（比萨大学医院和阿雷佐圣多纳托医院）进行的观察性前瞻性研究，包括 2021 年 3 月 20 日至 5 月 10 日接受 bamlanivimab/etesevimab 或 casirivimab/imdevimab 治疗的连续门诊 COVID-19 患者。所有患者均处于高危状态根据 FDA/AIFA 建议，COVID-19 进展的风险。根据感染病毒株（VOC）将患者分为两个研究组：Alpha组和Gamma组。主要终点是单克隆抗体输注后 30 天内住院或死亡的复合终点。进行 Cox 回归多变量分析以确定与总体人群中主要结果相关的因素。结果 该研究包括 165 名患者：105 名患者感染了 VOC Alpha，43 名患者感染了 VOC Gamma。在 Alpha 组中，接受 bamlanivimab/etesevimab 或 casirivimab/imdevimab 治疗的患者之间未观察到主要终点存在差异。相反，在 Gamma 组中，与接受 casirivimab/imdevimab 治疗的患者相比，接受 bamlanivimab/etesevimab 治疗的患者达到主要终点的比例更高（55% vs. 17.4%，p = 0.013）。在多变量 Cox 回归分析中，Gamma 变异和从症状出现到单克隆抗体输注的天数是与住院或死亡风险较高独立相关的因素，而 casirivimab/imdevimab 具有保护作用（HR 0.33，95% CI 0.13-0.83，p = 0.019） ）。结论 在 SARS-CoV-2 Gamma 变种感染的患者中，应谨慎使用 bamlanivimab/etesevimab，因为疾病进展的风险很高。