OBJECTIVE: To evaluate the experience with use of Sotrovimab following Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2) infection in high-risk groups Design A nationwide, population-based, cohort study.

METHODS: We identified all individuals treated with Sotrovimab (N=2,933) and stratified them by four high-risk groups: A) malignant hematological disease, B) solid organ transplantation (SOT), C) Anti-CD20 therapy ≤ 1 year, and D) "other risks". Cox regression analysis was used to calculate hazard ratios for hospitalization, death, and associated prognostic factors.

RESULTS: Of 2,933 Sotrovimab-treated individuals, 83% belonged to high-risk groups (37.6% hematological malignancy, 27.4% SOT and 17.5% treatment with Anti-CD20 ≤ 1 year). Only 17.8% had "other risks" (11.8% were pregnant, 10.7% primary immunodeficiency, 21.2% other malignancy, 4.3% received Anti-CD20 > 1 year,52.0% other/unknown causes). Within 90 days of infusion, 30.2% were hospitalized and 5.3% died. The main prognostic factors were the predefined high-risk groups, mainly malignant hematological disease, and age ≥ 65 years. Number of COVID-19 vaccines (≥3) was associated with a decreased risk of hospitalization. The Delta but not the Omicron BA.2 variant, was associated with a higher risk of death compared to the BA.1 variant.

CONCLUSION: In conclusion, more than 90% of the patients treated with Sotrovimab belonged to the very high-risk groups as described in the Danish guidelines. Sotrovimab treated individuals remained at a high risk of hospitalization and death which was strongly associated with the underlying immunocompromised state and age. Having received more than three COVID-19 vaccines was association with decreased risk of death and hospitalization.