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COVID-19 and MIS-C treatment in children—results from an international survey

Children have been mostly excluded from COVID-19 clinical trials, and, as a result, most medicines approved for COVID-19 have no pediatric indication. In addition, access to COVID-19 therapeutics remains limited. Collecting physicians’ experiences with off-label use of therapeutics is important to i...

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Autores principales: Donà, Daniele, Minotti, Chiara, Masini, Tiziana, Penazzato, Martina, Van Der Zalm, Marieke M., Judd, Ali, Giaquinto, Carlo, Lallemant, Marc
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10640428/
https://www.ncbi.nlm.nih.gov/pubmed/37672062
http://dx.doi.org/10.1007/s00431-023-05179-7
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author Donà, Daniele
Minotti, Chiara
Masini, Tiziana
Penazzato, Martina
Van Der Zalm, Marieke M.
Judd, Ali
Giaquinto, Carlo
Lallemant, Marc
author_facet Donà, Daniele
Minotti, Chiara
Masini, Tiziana
Penazzato, Martina
Van Der Zalm, Marieke M.
Judd, Ali
Giaquinto, Carlo
Lallemant, Marc
author_sort Donà, Daniele
collection PubMed
description Children have been mostly excluded from COVID-19 clinical trials, and, as a result, most medicines approved for COVID-19 have no pediatric indication. In addition, access to COVID-19 therapeutics remains limited. Collecting physicians’ experiences with off-label use of therapeutics is important to inform global prioritization processes and better target pediatric research and development. A standardized questionnaire was designed to explore the use of therapeutics used to treat COVID-19 and multisystem inflammatory syndrome in children (MIS-C) in pediatric patients globally. Seventy-three physicians from 29 countries participated. For COVID-19, steroids were used by 75.6% of respondents; remdesivir and monoclonal antibodies were prescribed by 48.6% and 27.1% of respondents, respectively. For MIS-C, steroids were prescribed by 79.1% of respondents and intravenous immunoglobulins by 69.6%. The use of these products depended on their pediatric approval and the limited availability of antivirals and most monoclonal antibodies in Africa, South America, Southeast Asia, and Eastern Europe. Off-label prescription resulted widespread due to the paucity of clinical trials in young children at the time of the survey; though, based on our survey results, it was generally safe and led to clinical benefits.   Conclusion: This survey provides a snapshot of current practice for treating pediatric COVID-19 worldwide, informing global prioritization efforts to better target pediatric research and development for COVID-19 therapeutics. Off-label use of such medicines is widespread for the paucity of clinical trials under 12 years and 40 kg, though appears to be safe and generally results in clinical benefits, even in young children. However, access to care, including medicine availability, differs widely globally. Clinical development of COVID-19 antivirals and monoclonal antibodies requires acceleration to ensure pediatric indication and allow worldwide availability of therapeutics that will enable more equitable access to COVID-19 treatment. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00431-023-05179-7.
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spelling pubmed-106404282023-11-14 COVID-19 and MIS-C treatment in children—results from an international survey Donà, Daniele Minotti, Chiara Masini, Tiziana Penazzato, Martina Van Der Zalm, Marieke M. Judd, Ali Giaquinto, Carlo Lallemant, Marc Eur J Pediatr Research Children have been mostly excluded from COVID-19 clinical trials, and, as a result, most medicines approved for COVID-19 have no pediatric indication. In addition, access to COVID-19 therapeutics remains limited. Collecting physicians’ experiences with off-label use of therapeutics is important to inform global prioritization processes and better target pediatric research and development. A standardized questionnaire was designed to explore the use of therapeutics used to treat COVID-19 and multisystem inflammatory syndrome in children (MIS-C) in pediatric patients globally. Seventy-three physicians from 29 countries participated. For COVID-19, steroids were used by 75.6% of respondents; remdesivir and monoclonal antibodies were prescribed by 48.6% and 27.1% of respondents, respectively. For MIS-C, steroids were prescribed by 79.1% of respondents and intravenous immunoglobulins by 69.6%. The use of these products depended on their pediatric approval and the limited availability of antivirals and most monoclonal antibodies in Africa, South America, Southeast Asia, and Eastern Europe. Off-label prescription resulted widespread due to the paucity of clinical trials in young children at the time of the survey; though, based on our survey results, it was generally safe and led to clinical benefits.   Conclusion: This survey provides a snapshot of current practice for treating pediatric COVID-19 worldwide, informing global prioritization efforts to better target pediatric research and development for COVID-19 therapeutics. Off-label use of such medicines is widespread for the paucity of clinical trials under 12 years and 40 kg, though appears to be safe and generally results in clinical benefits, even in young children. However, access to care, including medicine availability, differs widely globally. Clinical development of COVID-19 antivirals and monoclonal antibodies requires acceleration to ensure pediatric indication and allow worldwide availability of therapeutics that will enable more equitable access to COVID-19 treatment. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00431-023-05179-7. Springer Berlin Heidelberg 2023-09-06 2023 /pmc/articles/PMC10640428/ /pubmed/37672062 http://dx.doi.org/10.1007/s00431-023-05179-7 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Research
Donà, Daniele
Minotti, Chiara
Masini, Tiziana
Penazzato, Martina
Van Der Zalm, Marieke M.
Judd, Ali
Giaquinto, Carlo
Lallemant, Marc
COVID-19 and MIS-C treatment in children—results from an international survey
title COVID-19 and MIS-C treatment in children—results from an international survey
title_full COVID-19 and MIS-C treatment in children—results from an international survey
title_fullStr COVID-19 and MIS-C treatment in children—results from an international survey
title_full_unstemmed COVID-19 and MIS-C treatment in children—results from an international survey
title_short COVID-19 and MIS-C treatment in children—results from an international survey
title_sort covid-19 and mis-c treatment in children—results from an international survey
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10640428/
https://www.ncbi.nlm.nih.gov/pubmed/37672062
http://dx.doi.org/10.1007/s00431-023-05179-7
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