Abstract

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.

Details

Title
The use of remdesivir outside of clinical trials during the COVID-19 pandemic
Author
Halimi, Vesa; Daci, Armond; Ridova, Nevenka; Panovska-Stavridis, Irina; Stevanovic, Milena; Filipce, Venko; Dimovski, Aleksandar; Grozdanova, Aleksandra  VIAFID ORCID Logo 
Pages
1-8
Section
Commentary
Publication year
2020
Publication date
2020
Publisher
BioMed Central
e-ISSN
20523211
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s40545-020-00258-8
ProQuest document ID
2451754176
Copyright
© 2020. This work is licensed under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.