Safety of Sotrovimab use in children with COVID-19: an Italian experience

Abstract

Sotrovimab is a monoclonal antibody approved in adult and adolescents at high risk for COVID-19. Thirty-three children evaluated in five Italian paediatric centres received Sotrovimab infusion and were retrospectively enrolled from December 2021 to April 2022. In more than half of cases (19/33, 57.6%) Sotrovimab was prescribed off-label. Overall, the infusion was well tolerated with no significative differences in those receiving an off-label prescription. All children had a complete recovery. Data on the safety of Sotrovimab should be investigated in a larger paediatric cohort, considering the continuous selection of new SARS CoV-2 variants which may be more or less susceptible to the effects of the Sotrovimab.

Keywords:

• Sotrovimab
• SARS-CoV-2
• omicron
• monoclonal antibodies
• children
• covid-19
• variant of concern

Acknowledgments

Author Contributions: Conceptualization L.G., E.V., A.LV., G.CG and L.F.; methodology E.V, A.LV, SM.S and S.G; validation L.G., G.CG and E.V.; formal analysis E.V. and L.F; investigation E.V., A.LV., D.D, G.P. and L.F.; resources A.LV., L.G, G.CG and E.V; data curation L.G., E.V., A.LV., G.CG, S.G, D.D and L.F.; writing—original draft preparation, E.V. and L.F.; writing—review and editing L.G., A.LV., G.CG, SM.S, S.G, G.P, D.D, E, V, and L.F; supervision, L.G. and G.CG.; project administration, L.G. All authors have read and agreed to the published version of the manuscript.

Disclosure statement

No potential conflict of interest was reported by the authors.

Correction Statement

This article has been corrected with minor changes. These changes do not impact the academic content of the article.