Prospective Cohort Study to Monitor the Emergence of SARS-CoV-2 Spike Viral Variants in Immunocompromised Non-hospitalized Patients Exposed to Sotrovimab in Great Britain: LUNAR Study

Sotrovimab binds to a conserved epitope on the severe acute respiratory syndrome coronavirus (SARS-CoV) and SARS-CoV-2 spike protein outside the receptor-binding motif and has been shown to reduce the risk of hospitalization and/or death when administered as early treatment in non-hospitalized patients that are at risk for progression to severe disease. Immunocompromised (IC) patients are prioritized to receive early treatment for COVID-19 as they are at high risk of disease progression, and because of their potential for prolonged viral shedding and the resulting increased risk of emergent viral mutations and potential onward community transmission.This genomic surveillance study will aim to describe changes in the SARS-CoV-2 spike protein observed in IC participants receiving sotrovimab as standard of clinical care in sentinel sites at a national level to assess potential emergence of viral variants.

索特罗维单抗（Sotrovimab）可结合严重急性呼吸综合征冠状病毒（SARS-CoV）与SARS冠状病毒2型（SARS-CoV-2）刺突蛋白受体结合基序（receptor-binding motif）之外的保守表位，研究显示在存在重症进展风险的非住院患者中早期给予该药物治疗，可降低住院及/或死亡风险。免疫功能低下（IC）患者被优先推荐接受新型冠状病毒肺炎（COVID-19）早期治疗，原因在于这类人群不仅重症进展风险较高，还可能出现病毒持续脱落的情况，进而增加病毒突变株出现及后续社区传播的风险。本基因组监测研究旨在描述全国范围内哨点监测点中，接受以索特罗维单抗为标准临床治疗的免疫功能低下受试者体内所观察到的SARS-CoV-2刺突蛋白变化，以此评估病毒变异株的潜在出现情况。