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

Journal
Journal of Pharmaceutical Policy and Practice
Date Issued
2020-09-21
Author(s)
Vesa Halimi
Armond Daci
DOI
https://doi.org/10.1186/s40545-020-00258-8
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.
Subjects

COVID-19

clinical practice

clinical trials

compassionate use

conditional approval

early access scheme

emergency use

expanded access

remdesivir

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