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, 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

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.

© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America.

Figures

Figure 1.
Figure 1.
A, Elimination of SARS-CoV-2 in nasopharyngeal and/or oropharyngeal swabs of patients treated with AVIFAVIR or SOC on Day 5 and Day 10 of the study treatment. B, Time to normal body temperature in patients treated with AVIFAVIR or SOC (Kaplan-Meier curves). Abbreviations: SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; SOC, standard of care.

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Source: PubMed

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