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

Vesa Halimi; Armond Daci; Nevenka Ridova; Irina Panovska-Stavridis; Milena Stevanovic; Venko Filipce; Aleksandar Dimovski; Aleksandra Grozdanova

doi:10.1186/s40545-020-00258-8

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

J Pharm Policy Pract. 2020 Sep 21:13:61. doi: 10.1186/s40545-020-00258-8. eCollection 2020.

Authors

Vesa Halimi¹, Armond Daci², Nevenka Ridova³, Irina Panovska-Stavridis³, Milena Stevanovic⁴, Venko Filipce⁵, Aleksandar Dimovski¹, Aleksandra Grozdanova¹

Affiliations

¹ Faculty of Pharmacy, University Ss. Cyril and Methodius University, Skopje, North Macedonia.
² Department of Pharmacy, Faculty of Medicine, University of Prishtina, Prishtina, Kosovo.
³ University Clinic of Hematology, Medical Faculty, University Ss. Cyril and Methodius University, Skopje, North Macedonia.
⁴ University Clinic of Infection Diseases and Febrile Conditions, Medical Faculty, University Ss. Cyril and Methodius, Skopje, North Macedonia.
⁵ University Clinic for Neurosurgery, Medical Faculty, University Ss. Cyril and Methodius, Skopje, North Macedonia.

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.

Keywords: COVID-19; Clinical practice; Clinical trials; Compassionate use; Conditional approval; Early access scheme; Emergency use; Expanded access; Remdesivir.