Background: Sotrovimab is a neutralising monoclonal antibody (nMAB) currently available to treat extremely clinically vulnerable COVID-19 patients in England. Trials have shown it to have mild to moderate side effects, however, evidence regarding its safety in real-world settings remains insufficient.
Methods: Descriptive and multivariable logistic regression analyses were conducted to evaluate uptake, and a self-controlled case series analysis performed to measure the risk of hospital admission (hospitalisation) associated with 49 pre-specified suspected adverse outcomes in the period 2-28 days post-Sotrovimab treatment among eligible patients treated between December 11, 2021 and May 24, 2022.
Results: Here we show that among treated and untreated eligible individuals, the mean ages (54.6 years, SD: 16.1 vs 54.1, SD: 18.3) and sex distribution (women: 60.9% vs 58.1%; men: 38.9% vs 41.1%) are similar. There are marked variations in uptake between ethnic groups, which is higher amongst individuals categorised ethnically as Indian (15.0%; 95%CI 13.8, 16.3), Other Asian (13.7%; 95%CI 11.9, 15.8), white (13.4%; 95%CI 13.3, 13.6), and Bangladeshi (11.4%; 95%CI 8.8, 14.6); and lower amongst Black Caribbean individuals (6.4%; 95%CI 5.4, 7.5) and Black Africans (4.7%; 95%CI 4.1, 5.4). We find no increased risk of any of the suspected adverse outcomes in the period 2-28 days post-treatment.
Conclusions: We find no safety signals of concern for possible adverse outcomes in the period 2-28 days post treatment with Sotrovimab. However, there is evidence of unequal uptake of Sotrovimab treatment across ethnic groups.
Sotrovimab is a medical treatment which may improve the chance of recovery and survival of patients with weak immune systems who have COVID-19. However, the safety of Sotrovimab treatment and the characteristics of the people who receive it are not well understood. We analysed the risk of serious side-effects which resulted in those who were treated with Sotrovimab needing to be hospitalised, along with the characteristics of the treated patients. No evidence of serious side-effects from Sotrovimab treatment requiring hospitalisation was found, but some ethnic groups were more likely to be treated than others. Therefore, there is evidence that Sotrovimab may be a safe treatment for people with weak immune systems who have COVID-19, but some work may be needed to make sure the treatment is used more equitably among different ethnic groups.
© 2025. The Author(s).