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Published on: February 14, 2011
Implementation and Patient Outcomes of a Pediatric COVID-19 Monoclonal Antibody Program
Jill E Blind1, Matt Sapko1, Alex Killough1
1Department of Pharmacy, Nationwide Children's Hospital, Columbus, Ohio, USA.
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 the 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 sociodemographics, qualifying underlying medical conditions, 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.
Conclusions:
A tiered allocation process may provide the framework for the stratification and efficient distribution of mAb therapies. Future research must focus on the efficacy of these therapies in the pediatric population, standardized therapeutic prioritization, and the optimal timeframe for mAb delivery to prevent progression to severe disease.
Insights
A tiered system for monoclonal antibody (mAb) therapy allocation in pediatric COVID-19 patients was implemented. This process facilitated efficient distribution and provided insights into clinical outcomes for young individuals receiving these treatments.
Area of Science:
- Pediatric Infectious Diseases
- Immunotherapy
- Public Health
Background:
- The COVID-19 pandemic necessitated rapid development of therapeutic strategies, including monoclonal antibodies (mAbs).
- Limited data previously advised against routine use of COVID-19 mAbs in pediatric populations, emphasizing individualized risk assessment.
- This study details the implementation of a mAb referral process and evaluates clinical outcomes in a pediatric hospital setting.
Purpose of the Study:
- To describe the implementation of a standardized monoclonal antibody (mAb) referral process for pediatric patients with COVID-19.
- To assess the clinical outcomes of pediatric patients who received mAb infusions for treatment or post-exposure prophylaxis.
- To evaluate the effectiveness of a tiered allocation system for mAb therapies in a pediatric hospital.
Main Methods:
- A tiered allocation system was developed based on underlying medical conditions for COVID-19 mAb therapy.
- A standardized referral and approval process was integrated for mAb administration.
- Clinical data, including demographics, medical conditions, and disease course, were collected for 182 pediatric patients (≤21 years) receiving mAb infusions.
Main Results:
- A total of 182 pediatric patients received monoclonal antibody (mAb) infusions between November 2020 and January 2022.
- The median age of patients receiving mAb therapy was 15 years, with a range from 10 months to 21 years.
- Adverse reactions during infusion were reported in 4% of patients, and 8% required a COVID-19-related visit within 30 days post-infusion.
Conclusions:
- A tiered allocation process can effectively stratify and distribute monoclonal antibody (mAb) therapies in pediatric settings.
- Further research is needed on mAb efficacy, standardized prioritization, and optimal timing for pediatric COVID-19 treatment.
- The findings support the development of frameworks for equitable and efficient access to mAb therapies for children and adolescents.
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