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

[摘要] 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.

[学科分类] 药理学

[关键词] COVID-19;Remdesivir;Clinical practice;Clinical trials;Expanded access;Compassionate use;Early access scheme;Emergency use;Conditional approval