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

Author:

Ivashchenko Andrey A1,Dmitriev Kirill A2,Vostokova Natalia V3,Azarova Valeria N3,Blinow Andrew A4,Egorova Alina N3,Gordeev Ivan G5,Ilin Alexey P6,Karapetian Ruben N7,Kravchenko Dmitry V6,Lomakin Nikita V8,Merkulova Elena A3,Papazova Natalia A9,Pavlikova Elena P10,Savchuk Nikolay P11,Simakina Elena N12,Sitdekov Tagir A2,Smolyarchuk Elena A13,Tikhomolova Elena G14,Yakubova Elena V4,Ivachtchenko Alexandre V11

Affiliation:

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

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.

Funder

AVIFAVIR

Russian Direct Investment Fund

Trade of the Russian Federation and the Skolkovo Innovation Center

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Microbiology (medical)

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