Abstract
Background
The severity and reach of the COVID-19 pandemic drove the development of various therapeutic approaches to combat SARS-CoV-2, including several neutralizing monoclonal antibody (mAb) therapies. A January 2021 pediatric consensus statement opposed routine use and recommended individualized risk assessments when considering COVID-19 mAb therapies in children and adolescents due to limited data. This report describes the implementation of a mAb referral process and clinical outcomes of patients who received a mAb infusion in a pediatric hospital.
Methods
We developed a tiered allocation system based on underlying medical conditions and incorporated it into a standardized COVID-19 mAb referral and approval process. Demographics and clinical data were collected on all patients who received mAb therapy for treatment or post-exposure prophylaxis. Data recorded included socio-demographics, qualifying underlying medical condition, clinical manifestations of infection, and overall course of treatment and disease.
Results
A total of 182 patients ≤21 years old received a COVID-19 mAb infusion between November 27, 2020, and January 26, 2022. Patient age ranged from 10 months to 21 years, with a median age of 15 years. In total, 7 patients (4%) had suspected adverse reactions during the infusion, and 15 (8%) patients required a COVID-19-related visit within 30 days of the mAb infusion.
Conclusion
A tiered allocation process may provide the framework for the stratification and efficient distribution of mAb therapies. Future research must focus on efficacy of these therapies in the pediatric population, standardized therapeutic prioritization, and the optimal timeframe for mAb delivery to prevent progression to severe disease.
Keywords: COVID-19, Bamlanivimab, Casirivimab, SARS-CoV-2 Neutralizing Antibody, Sotrovimab, Pediatric
Contributor Information
Jill E Blind, Department of Pharmacy, Nationwide Children’s Hospital, Columbus, Ohio, USA.
Matt Sapko, Department of Pharmacy, Nationwide Children’s Hospital, Columbus, Ohio, USA.
Alex Killough, Department of Pharmacy, Nationwide Children’s Hospital, Columbus, Ohio, USA.
Hannah Thornton, Department of Pharmacy, Nationwide Children’s Hospital, Columbus, Ohio, USA.
Joshua R Watson, Department of Pediatrics, Center for Clinical Excellence, Nationwide Children’s Hospital and The Ohio State University, Columbus, Ohio, USA.
Supplementary Material
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.