AVIFAVIR for Treatment of Patients With Moderate Coronavirus Disease 2019 (COVID-19): Interim Results of a Phase II/III Multicenter Randomized Clinical Trial

Andrey A Ivashchenko; Kirill A Dmitriev; Natalia V Vostokova; Valeria N Azarova; Andrew A Blinow; Alina N Egorova; Ivan G Gordeev; Alexey P Ilin; Ruben N Karapetian; Dmitry V Kravchenko; Nikita V Lomakin; Elena A Merkulova; Natalia A Papazova; Elena P Pavlikova; Nikolay P Savchuk; Elena N Simakina; Tagir A Sitdekov; Elena A Smolyarchuk; Elena G Tikhomolova; Elena V Yakubova; Alexandre V Ivachtchenko

doi:10.1093/cid/ciaa1176

AVIFAVIR for Treatment of Patients With Moderate Coronavirus Disease 2019 (COVID-19): Interim Results of a Phase II/III Multicenter Randomized Clinical Trial

Clin Infect Dis. 2021 Aug 2;73(3):531-534. doi: 10.1093/cid/ciaa1176.

Authors

Andrey A Ivashchenko¹, Kirill A Dmitriev², Natalia V Vostokova³, Valeria N Azarova³, Andrew A Blinow⁴, Alina N Egorova³, Ivan G Gordeev⁵, Alexey P Ilin⁶, Ruben N Karapetian⁷, Dmitry V Kravchenko⁶, Nikita V Lomakin⁸, Elena A Merkulova³, Natalia A Papazova⁹, Elena P Pavlikova¹⁰, Nikolay P Savchuk¹¹, Elena N Simakina¹², Tagir A Sitdekov², Elena A Smolyarchuk¹³, Elena G Tikhomolova¹⁴, Elena V Yakubova⁴, Alexandre V Ivachtchenko¹¹

Affiliations

¹ ChemRar High-Tech Center, Khimki, Moscow region, Russian Federation.
² Russian Direct Investment Fund, Moscow, Russian Federation.
³ IPHARMA LLC, Skolkovo Innovative Centre, Moscow, Russian Federation.
⁴ Chromis LLC, Skolkovo Innovative Centre, Moscow, Russian Federation.
⁵ City Clinical Hospital n.a. O.M. Filatov, Moscow, Russian Federation.
⁶ Department of Chemistry and Technology, Chemical Diversity Research Institute, Khimki, Moscow region, Russian Federation.
⁷ Department of Biology, Chemical Diversity Research Institute, Khimki, Moscow region, Russian Federation.
⁸ Central Clinical Hospital with Polyclinic, Moscow, Russian Federation.
⁹ Department of Finished Dosage Forms, Chemical Diversity Research Institute, Khimki, Moscow region, Russian Federation.
¹⁰ Moscow State University n.a. M. V. Lomonosov, Moscow, Russian Federation.
¹¹ Chemical Diversity Research Institute, Khimki, Moscow region, Russian Federation.
¹² Clinical Hospital No.1, Smolensk, Russian Federation.
¹³ First Moscow State Medical University n.a. I.M. Sechenov, Moscow, Russian Federation.
¹⁴ Infectious clinical hospital No. 2, Nizhny Novgorod, Russian Federation.

Abstract

In May 2020 the Russian Ministry of Health granted fast-track marketing authorization to RNA polymerase inhibitor AVIFAVIR (favipiravir) for the treatment of COVID-19 patients. In the pilot stage of Phase II/III clinical trial, AVIFAVIR enabled SARS-CoV-2 viral clearance in 62.5% of patients within 4 days, and was safe and well-tolerated. Clinical Trials Registration. NCT04434248.

Keywords: AVIFAVIR; COVID-19; SARS-CoV-2; favipiravir.

Publication types

Clinical Trial, Phase II
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Antiviral Agents / therapeutic use
COVID-19*
Drug Therapy, Combination
Humans
SARS-CoV-2
Treatment Outcome

Substances

Antiviral Agents

Associated data

ClinicalTrials.gov/NCT04434248