The use of remdesivir outside of clinical trials during the COVID-19 pandemic

With a scientific background from filoviruses, paramyxoviruses, SARS-CoV, and MERS-CoV, remdesivir entered into the COVID-19 battle to become one of the favorable therapeutic candidates with potential antiviral activity in the treatment of this disease. Globally, remdesivir was accessed and investig...

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Autores principales: Halimi, Vesa, Daci, Armond, Ridova, Nevenka, Panovska-Stavridis, Irina, Stevanovic, Milena, Filipce, Venko, Dimovski, Aleksandar, Grozdanova, Aleksandra
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Commentary
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7503054/
https://www.ncbi.nlm.nih.gov/pubmed/32968487
http://dx.doi.org/10.1186/s40545-020-00258-8
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author Halimi, Vesa
Daci, Armond
Ridova, Nevenka
Panovska-Stavridis, Irina
Stevanovic, Milena
Filipce, Venko
Dimovski, Aleksandar
Grozdanova, Aleksandra
author_facet Halimi, Vesa
Daci, Armond
Ridova, Nevenka
Panovska-Stavridis, Irina
Stevanovic, Milena
Filipce, Venko
Dimovski, Aleksandar
Grozdanova, Aleksandra
author_sort Halimi, Vesa
collection PubMed
description With a scientific background from filoviruses, paramyxoviruses, SARS-CoV, and MERS-CoV, remdesivir entered into the COVID-19 battle to become one of the favorable therapeutic candidates with potential antiviral activity in the treatment of this disease. Globally, remdesivir was accessed and investigated through clinical research (clinical trials) and clinical practice (compassionate use, expanded access, early access scheme, and emergency use). Currently, remdesivir approval status differs between states. This paper aims to review and analyze regulatory approaches for accessing and investigating remdesivir, by communicating regulatory variability between countries in terms of terminology, modalities, and protocols.
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spelling pubmed-75030542020-09-21 The use of remdesivir outside of clinical trials during the COVID-19 pandemic Halimi, Vesa Daci, Armond Ridova, Nevenka Panovska-Stavridis, Irina Stevanovic, Milena Filipce, Venko Dimovski, Aleksandar Grozdanova, Aleksandra J Pharm Policy Pract Commentary With a scientific background from filoviruses, paramyxoviruses, SARS-CoV, and MERS-CoV, remdesivir entered into the COVID-19 battle to become one of the favorable therapeutic candidates with potential antiviral activity in the treatment of this disease. Globally, remdesivir was accessed and investigated through clinical research (clinical trials) and clinical practice (compassionate use, expanded access, early access scheme, and emergency use). Currently, remdesivir approval status differs between states. This paper aims to review and analyze regulatory approaches for accessing and investigating remdesivir, by communicating regulatory variability between countries in terms of terminology, modalities, and protocols. BioMed Central 2020-09-21 /pmc/articles/PMC7503054/ /pubmed/32968487 http://dx.doi.org/10.1186/s40545-020-00258-8 Text en © The Author(s) 2020 Open AccessThis 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/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Commentary
Halimi, Vesa
Daci, Armond
Ridova, Nevenka
Panovska-Stavridis, Irina
Stevanovic, Milena
Filipce, Venko
Dimovski, Aleksandar
Grozdanova, Aleksandra
The use of remdesivir outside of clinical trials during the COVID-19 pandemic
title The use of remdesivir outside of clinical trials during the COVID-19 pandemic
title_full The use of remdesivir outside of clinical trials during the COVID-19 pandemic
title_fullStr The use of remdesivir outside of clinical trials during the COVID-19 pandemic
title_full_unstemmed The use of remdesivir outside of clinical trials during the COVID-19 pandemic
title_short The use of remdesivir outside of clinical trials during the COVID-19 pandemic
title_sort use of remdesivir outside of clinical trials during the covid-19 pandemic
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7503054/
https://www.ncbi.nlm.nih.gov/pubmed/32968487
http://dx.doi.org/10.1186/s40545-020-00258-8
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