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473. Clinical Outcomes of a Pediatric COVID Monoclonal Antibody Program based at an Urban Academic Center
BACKGROUND: Growing clinical evidence in adults has demonstrated use of COVID monoclonal antibody (mAB) therapy results in a reduction of hospitalization and/or emergency room (ER) visits with the greatest benefit following early administration. While the FDA has authorized use of mAB therapy in chi...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8690654/ http://dx.doi.org/10.1093/ofid/ofab466.672 |
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author | Lee, Philip J Cruz, Carlos Anosike, I J |
author_facet | Lee, Philip J Cruz, Carlos Anosike, I J |
author_sort | Lee, Philip J |
collection | PubMed |
description | BACKGROUND: Growing clinical evidence in adults has demonstrated use of COVID monoclonal antibody (mAB) therapy results in a reduction of hospitalization and/or emergency room (ER) visits with the greatest benefit following early administration. While the FDA has authorized use of mAB therapy in children ages 12-17 years, clinical outcomes in this population have yet to be described. This study aims to assess the pediatric clinical experience in a low social economic setting. METHODS: Retrospective study conducted among children and adolescents who tested positive for SARS-CoV-2 from 12/1/2020 to 6/1/2021, met ≥ 1 eligibility criterion based on pre-determined institutional guidelines. Individuals were identified by patient-level data linked to pharmacy and medical claims with ICD-10 codes for COVID-19. Electronic medical records were reviewed for demographic characteristics, comorbidities, time to receipt of mAB therapy from positive test, adverse effects, and clinical outcomes. Primary clinical end point was hospitalization and/or medical visit at 28 days. Descriptive summary statistics were used for the entire cohort. RESULTS: Overall, 17 met eligibility criteria. Thirteen patients with a mean age of 16 years, received casirivimab and imdevimab mAB therapy: 4 declined treatment. Among the treated patients, 61.5% (n=8) were male, 38.6% (n=5) Hispanic/Latino; 38.6% (n=5) non-Hispanic Black; 7.7% (n=1) White. Seven out of 12 had a BMI ≥ 95th% for gender and age. Eight patients (61.5%) met ≥ 1 criteria with obesity (n=8) as the most common factor followed by immunocompromised state (n=6, 46.2%) tied with neurodevelopmental disorder (n=6, 46.2%). Median time from positive test to mAB therapy was 2 days [IQR:1-3]. One patient had a severe adverse event. Overall, none required hospitalization/ER visit with COVID like symptoms. Demographics and Results Table [Image: see text] The table describes the pediatric patients and clinical outcome of receiving monoclonal antibody treatment for COVID-19. CONCLUSION: Though limited by numbers, our findings may suggest a role of mAB therapy in children and adolescents in our setting. With increasing rates of SARS-CoV-2 in this age group coupled with vaccine hesitancy, mAB therapy may serve as an important outpatient intervention with a need for further studies to assess clinical benefit and establish optimal, cost-effective, practice guidelines for these highly vulnerable patients. DISCLOSURES: All Authors: No reported disclosures |
format | Online Article Text |
id | pubmed-8690654 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-86906542022-01-05 473. Clinical Outcomes of a Pediatric COVID Monoclonal Antibody Program based at an Urban Academic Center Lee, Philip J Cruz, Carlos Anosike, I J Open Forum Infect Dis Poster Abstracts BACKGROUND: Growing clinical evidence in adults has demonstrated use of COVID monoclonal antibody (mAB) therapy results in a reduction of hospitalization and/or emergency room (ER) visits with the greatest benefit following early administration. While the FDA has authorized use of mAB therapy in children ages 12-17 years, clinical outcomes in this population have yet to be described. This study aims to assess the pediatric clinical experience in a low social economic setting. METHODS: Retrospective study conducted among children and adolescents who tested positive for SARS-CoV-2 from 12/1/2020 to 6/1/2021, met ≥ 1 eligibility criterion based on pre-determined institutional guidelines. Individuals were identified by patient-level data linked to pharmacy and medical claims with ICD-10 codes for COVID-19. Electronic medical records were reviewed for demographic characteristics, comorbidities, time to receipt of mAB therapy from positive test, adverse effects, and clinical outcomes. Primary clinical end point was hospitalization and/or medical visit at 28 days. Descriptive summary statistics were used for the entire cohort. RESULTS: Overall, 17 met eligibility criteria. Thirteen patients with a mean age of 16 years, received casirivimab and imdevimab mAB therapy: 4 declined treatment. Among the treated patients, 61.5% (n=8) were male, 38.6% (n=5) Hispanic/Latino; 38.6% (n=5) non-Hispanic Black; 7.7% (n=1) White. Seven out of 12 had a BMI ≥ 95th% for gender and age. Eight patients (61.5%) met ≥ 1 criteria with obesity (n=8) as the most common factor followed by immunocompromised state (n=6, 46.2%) tied with neurodevelopmental disorder (n=6, 46.2%). Median time from positive test to mAB therapy was 2 days [IQR:1-3]. One patient had a severe adverse event. Overall, none required hospitalization/ER visit with COVID like symptoms. Demographics and Results Table [Image: see text] The table describes the pediatric patients and clinical outcome of receiving monoclonal antibody treatment for COVID-19. CONCLUSION: Though limited by numbers, our findings may suggest a role of mAB therapy in children and adolescents in our setting. With increasing rates of SARS-CoV-2 in this age group coupled with vaccine hesitancy, mAB therapy may serve as an important outpatient intervention with a need for further studies to assess clinical benefit and establish optimal, cost-effective, practice guidelines for these highly vulnerable patients. DISCLOSURES: All Authors: No reported disclosures Oxford University Press 2021-12-04 /pmc/articles/PMC8690654/ http://dx.doi.org/10.1093/ofid/ofab466.672 Text en © The Author(s) 2021. Published by Oxford University Press on behalf of Infectious Diseases Society of America. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Poster Abstracts Lee, Philip J Cruz, Carlos Anosike, I J 473. Clinical Outcomes of a Pediatric COVID Monoclonal Antibody Program based at an Urban Academic Center |
title | 473. Clinical Outcomes of a Pediatric COVID Monoclonal Antibody Program based at an Urban Academic Center |
title_full | 473. Clinical Outcomes of a Pediatric COVID Monoclonal Antibody Program based at an Urban Academic Center |
title_fullStr | 473. Clinical Outcomes of a Pediatric COVID Monoclonal Antibody Program based at an Urban Academic Center |
title_full_unstemmed | 473. Clinical Outcomes of a Pediatric COVID Monoclonal Antibody Program based at an Urban Academic Center |
title_short | 473. Clinical Outcomes of a Pediatric COVID Monoclonal Antibody Program based at an Urban Academic Center |
title_sort | 473. clinical outcomes of a pediatric covid monoclonal antibody program based at an urban academic center |
topic | Poster Abstracts |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8690654/ http://dx.doi.org/10.1093/ofid/ofab466.672 |
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