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Early Treatments of Fragile Children with COVID-19—Results of CLEVER (Children COVID Early Treatment), a Retrospective, Observational Study

(1) Background: SARS-CoV-2 infection is notably mild in children, though comorbidities may increase the risk of hospitalization and may represent a risk for increased disease severity. There is an urgent need for targeted therapies with an acceptable efficacy and safety profile. To date, most of the...

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Autores principales: Minotti, Chiara, Mengato, Daniele, De Pieri, Marica, Trivellato, Sabrina, Francavilla, Andrea, Di Chiara, Costanza, Liberati, Cecilia, Mattera, Raffaele, Biffi, Alessandra, Giaquinto, Carlo, Venturini, Francesca, Donà, Daniele
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9867507/
https://www.ncbi.nlm.nih.gov/pubmed/36680232
http://dx.doi.org/10.3390/v15010192
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author Minotti, Chiara
Mengato, Daniele
De Pieri, Marica
Trivellato, Sabrina
Francavilla, Andrea
Di Chiara, Costanza
Liberati, Cecilia
Mattera, Raffaele
Biffi, Alessandra
Giaquinto, Carlo
Venturini, Francesca
Donà, Daniele
author_facet Minotti, Chiara
Mengato, Daniele
De Pieri, Marica
Trivellato, Sabrina
Francavilla, Andrea
Di Chiara, Costanza
Liberati, Cecilia
Mattera, Raffaele
Biffi, Alessandra
Giaquinto, Carlo
Venturini, Francesca
Donà, Daniele
author_sort Minotti, Chiara
collection PubMed
description (1) Background: SARS-CoV-2 infection is notably mild in children, though comorbidities may increase the risk of hospitalization and may represent a risk for increased disease severity. There is an urgent need for targeted therapies with an acceptable efficacy and safety profile. To date, most of the medicines for COVID-19-specific treatment are prescribed off-label for children due to a lack of clinical trials and consequent evidence in this population. (2) Methods: This was a retrospective, observational study investigating the safety of treatments for the prevention of severe COVID-19 in fragile pediatric patients who received monoclonal antibodies and antivirals for mild-to-moderate symptoms between December 2021 and July 2022. (3) Results: Thirty-two patients were included. Monoclonal antibodies were prescribed to 62%, intravenous antivirals to 22%, and oral antivirals to 16% of children. Sotrovimab was the most frequently prescribed drug among monoclonal antibodies and overall (59%). The second most prescribed drug was remdesivir (22%). No severe adverse drug reaction was reported. There was no progression to severe disease and no death cases due to COVID-19 or drug administration. At drug-type stratification, resolution of symptoms and swab positivity time showed no difference between the two groups at 7 and 28 days. Off-label prescriptions were 84% overall, and in similar proportions between the two groups. (4) Conclusions: in this small sample, antivirals seemed safe and showed no differences in efficacy as compared to MAbs for the early treatment of COVID-19 in fragile children, thus representing a valuable choice, even when administered off-label.
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spelling pubmed-98675072023-01-22 Early Treatments of Fragile Children with COVID-19—Results of CLEVER (Children COVID Early Treatment), a Retrospective, Observational Study Minotti, Chiara Mengato, Daniele De Pieri, Marica Trivellato, Sabrina Francavilla, Andrea Di Chiara, Costanza Liberati, Cecilia Mattera, Raffaele Biffi, Alessandra Giaquinto, Carlo Venturini, Francesca Donà, Daniele Viruses Article (1) Background: SARS-CoV-2 infection is notably mild in children, though comorbidities may increase the risk of hospitalization and may represent a risk for increased disease severity. There is an urgent need for targeted therapies with an acceptable efficacy and safety profile. To date, most of the medicines for COVID-19-specific treatment are prescribed off-label for children due to a lack of clinical trials and consequent evidence in this population. (2) Methods: This was a retrospective, observational study investigating the safety of treatments for the prevention of severe COVID-19 in fragile pediatric patients who received monoclonal antibodies and antivirals for mild-to-moderate symptoms between December 2021 and July 2022. (3) Results: Thirty-two patients were included. Monoclonal antibodies were prescribed to 62%, intravenous antivirals to 22%, and oral antivirals to 16% of children. Sotrovimab was the most frequently prescribed drug among monoclonal antibodies and overall (59%). The second most prescribed drug was remdesivir (22%). No severe adverse drug reaction was reported. There was no progression to severe disease and no death cases due to COVID-19 or drug administration. At drug-type stratification, resolution of symptoms and swab positivity time showed no difference between the two groups at 7 and 28 days. Off-label prescriptions were 84% overall, and in similar proportions between the two groups. (4) Conclusions: in this small sample, antivirals seemed safe and showed no differences in efficacy as compared to MAbs for the early treatment of COVID-19 in fragile children, thus representing a valuable choice, even when administered off-label. MDPI 2023-01-10 /pmc/articles/PMC9867507/ /pubmed/36680232 http://dx.doi.org/10.3390/v15010192 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Minotti, Chiara
Mengato, Daniele
De Pieri, Marica
Trivellato, Sabrina
Francavilla, Andrea
Di Chiara, Costanza
Liberati, Cecilia
Mattera, Raffaele
Biffi, Alessandra
Giaquinto, Carlo
Venturini, Francesca
Donà, Daniele
Early Treatments of Fragile Children with COVID-19—Results of CLEVER (Children COVID Early Treatment), a Retrospective, Observational Study
title Early Treatments of Fragile Children with COVID-19—Results of CLEVER (Children COVID Early Treatment), a Retrospective, Observational Study
title_full Early Treatments of Fragile Children with COVID-19—Results of CLEVER (Children COVID Early Treatment), a Retrospective, Observational Study
title_fullStr Early Treatments of Fragile Children with COVID-19—Results of CLEVER (Children COVID Early Treatment), a Retrospective, Observational Study
title_full_unstemmed Early Treatments of Fragile Children with COVID-19—Results of CLEVER (Children COVID Early Treatment), a Retrospective, Observational Study
title_short Early Treatments of Fragile Children with COVID-19—Results of CLEVER (Children COVID Early Treatment), a Retrospective, Observational Study
title_sort early treatments of fragile children with covid-19—results of clever (children covid early treatment), a retrospective, observational study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9867507/
https://www.ncbi.nlm.nih.gov/pubmed/36680232
http://dx.doi.org/10.3390/v15010192
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