(1) 引言：自2021年5月以来，sotrovimab已在意大利用于SARS-CoV-2感染的早期治疗和预防疾病进展。然而，一些体外研究对其在Omicron变异株上的疗效产生了质疑。因此，我们的目标是进一步研究sotrovimab在真实生活环境中的疗效。 (2) 方法：我们进行了一项回顾性研究，收集了意大利Sassari、Foggia和Bari的传染病科病历。我们纳入了2022年接受sotrovimab治疗和未接受任何治疗的SARS-CoV-2感染者。主要研究结果是评估sotrovimab在减少疾病进展（定义为需要开始吸氧）和COVID-19相关死亡方面的疗效。次要研究结果是评估sotrovimab的安全性。 (3) 结果：我们纳入了689人，其中341人接受了sotrovimab治疗，而348人未接受任何治疗。总体上，我们登记了161例（23.4%）疾病进展和65例（9.4%）死亡，治疗组和未治疗组之间存在显著差异（p < 0.001）。在多变量 logistic 回归分析中，年龄增加 [十年年龄增加的 OR 为 1.23（95%CI 1.04-1.45）] 与疾病进展风险增加相关。此外，心血管疾病 [OR 1.69（1.01-2.80）]、发热 [OR 3.88（95%CI 2.35-6.38）] 和呼吸困难 [OR 7.24（95%CI 4.17-12.58）] 与疾病进展风险增加相关。相反，接种疫苗 [OR 0.21（95%CI 0.12-0.37）] 和sotrovimab治疗 [OR 0.05（95%CI 0.02-0.11）] 与发展严重COVID-19的风险降低相关。关于死亡率，年龄较大者 [十年年龄增加的 OR 为 1.36（95%CI 1.09-1.69）] 死亡风险更高。此外，在多变量分析中，心血管疾病失去了统计学意义，而接受血液癌症化疗的患者 [OR 4.07（95%CI 1.45-11.4）] 和诊断时呼吸困难的患者 [OR 3.63（95%CI 2.02-6.50）] 具有死亡风险增加。相反，接种疫苗 [OR 0.37（95%CI 0.20-0.68）] 和sotrovimab治疗 [OR 0.16（95%CI 0.06-0.42）] 与较低的风险相关。仅报告了两起不良事件：一人在sotrovimab治疗后几小时出现腹泻，另一人出现过敏反应，伴有皮疹和瘙痒。 (4) 结论：我们的研究显示，sotrovimab治疗与SARS-CoV-2感染者疾病进展和死亡风险降低相关，其中70%年龄超过65岁，并且接种率较高，具有良好的安全性。因此，我们的结果强化了关于Omicron时代sotrovimab疗效和安全性的证据在真实世界环境中的有效性。

(1) Introduction: Since May 2021, sotrovimab has been available in Italy for early treatment of SARS-CoV-2 infection and to prevent disease progression. However, some in vitro studies have questioned its efficacy on Omicron variants. Therefore, we aim to further investigate the efficacy of sotrovimab in real-life settings. (2) Methods: We conducted a retrospective study collecting medical records of people with SARS-CoV-2 infection evaluated in the infectious diseases units of Sassari, Foggia, and Bari, Italy. We included people with SARS-CoV-2 infection treated with sotrovimab and people who did not receive any treatment in 2022. The primary study outcome was to evaluate the efficacy of sotrovimab in reducing disease progression (defined as the necessity of starting oxygen supplementation) and COVID-19-related death. The secondary outcome was to evaluate the safety of sotrovimab. (3) Results: We included 689 people; of them, 341 were treated with sotrovimab, while 348 did not receive any treatment. Overall, we registered 161 (23.4%) disease progressions and 65 (9.4%) deaths, with a significant difference between treated and not-treated people (p < 0.001). In the multivariate logistic regression, increasing age [OR for ten years increasing age 1.23 (95%CI 1.04-1.45)] was associated with a higher risk of disease progression. In addition, cardiovascular disease [OR 1.69 (1.01-2.80), fever [OR 3.88 (95%CI 2.35-6.38)], and dyspnea [OR 7.24 (95%CI 4.17-12.58)] were associated with an increased risk of disease progression. In contrast, vaccination [OR 0.21 (95%CI 0.12-0.37)] and sotrovimab administration [OR 0.05 (95%CI 0.02-0.11)] were associated with a lower risk of developing severe COVID-19. Regarding mortality, people with older age [OR for ten years increasing age 1.36 (95%CI 1.09-1.69)] had a higher risk of death. In addition, in the multivariate analysis, cardiovascular disease lost statistical significance, while people on chemotherapy for haematological cancer [OR 4.07 (95%CI 1.45-11.4)] and those with dyspnea at diagnosis [OR 3.63 (95%CI 2.02-6.50)] had an increased risk of death. In contrast, vaccination [OR 0.37 (95%CI 0.20-0.68)] and sotrovimab treatment [OR 0.16 (95%CI 0.06-0.42)] were associated with lower risk. Only two adverse events were reported; one person complained of diarrhoea a few hours after sotrovimab administration, and one had an allergic reaction with cutaneous rash and itching. (4) Conclusions: Our study showed that sotrovimab treatment was associated with a reduction of the risk of disease progression and death in SARS-CoV-2-infected people, 70% of whom were over 65 years and a with high vaccination rate, with excellent safety. Therefore, our results reinforce the evidence about the efficacy and safety of sotrovimab during the Omicron era in a real-world setting.