AVIFAVIR for Treatment of Patients with Moderate COVID-19: Interim Results of a Phase II/III Multicenter Randomized Clinical Trial
Interim results for a small RCT with 40 favipiravir and 20 control patients showing faster viral clearance with favipiravir. There is limited data in this report to evaluate the results. 75% of the control group received HCQ/CQ.
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risk of death, 300.0% higher, RR 4.00, p = 0.55, treatment 2 of 40 (5.0%), control 0 of 20 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm), day 29.
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risk of mechanical ventilation, 300.0% higher, RR 4.00, p = 0.55, treatment 2 of 40 (5.0%), control 0 of 20 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
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risk of ICU admission, 300.0% higher, RR 4.00, p = 0.55, treatment 2 of 40 (5.0%), control 0 of 20 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
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risk of no viral clearance, 46.4% lower, RR 0.54, p = 0.03, treatment 15 of 40 (37.5%), control 14 of 20 (70.0%), NNT 3.1, mid-recovery day 5.
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risk of no viral clearance, 62.5% lower, RR 0.37, p = 0.21, treatment 3 of 40 (7.5%), control 4 of 20 (20.0%), NNT 8.0, day 10.
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risk of no discharge and WHO-OSC>2, 66.7% higher, RR 1.67, p = 0.51, treatment 10 of 40 (25.0%), control 3 of 20 (15.0%).
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Ivashchenko et al., 9 Aug 2020, Randomized Controlled Trial, Russia, peer-reviewed, 21 authors, study period April 2020 - May 2020, average treatment delay 6.7 days.
Abstract: Clinical Infectious Diseases
BRIEF REPORT
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,1 Kirill A. Dmitriev,2 Natalia V. Vostokova,3
Valeria N. Azarova,3 Andrew A. Blinow,4 Alina N. Egorova,3 Ivan G. Gordeev,5
Alexey P. Ilin,6 Ruben N. Karapetian,7 Dmitry V. Kravchenko,6 Nikita V. Lomakin,8
Elena A. Merkulova,3 Natalia A. Papazova,9 Elena P. Pavlikova,10
Nikolay P. Savchuk,11 Elena N. Simakina,12 Tagir A. Sitdekov,2
Elena A. Smolyarchuk,13 Elena G. Tikhomolova,14 Elena V. Yakubova,4 and
Alexandre V. Ivachtchenko11
ChemRar High-Tech Center, Khimki, Moscow region, Russian Federation, 2Russian Direct
Investment Fund, Moscow, Russian Federation, 3IPHARMA LLC, Skolkovo Innovative Centre,
Moscow, Russian Federation, 4Chromis LLC, Skolkovo Innovative Centre, Moscow, Russian
Federation, 5City Clinical Hospital n.a. O.M. Filatov, Moscow, Russian Federation, 6Department
of Chemistry and Technology, Chemical Diversity Research Institute, Khimki, Moscow region,
Russian Federation, 7Department of Biology, Chemical Diversity Research Institute, Khimki,
Moscow region, Russian Federation, 8Central Clinical Hospital with Polyclinic, Moscow,
Russian Federation, 9Department of Finished Dosage Forms, Chemical Diversity Research
Institute, Khimki, Moscow region, Russian Federation, 10Moscow State University n.a. M. V.
Lomonosov, Moscow, Russian Federation, 11Chemical Diversity Research Institute, Khimki,
Moscow region, Russian Federation, 12Clinical Hospital No.1, Smolensk, Russian Federation,
13
First Moscow State Medical University n.a. I.M. Sechenov, Moscow, Russian Federation, and
14
Infectious clinical hospital No. 2, Nizhny Novgorod, Russian Federation
1
In May 2020 the Russian Ministry of Health granted fasttrack 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;
favipiravir;
COVID-19;
SARS-CoV-2.
The pandemic of the novel coronavirus infection (COVID-19)
represents an unprecedented disaster for healthcare providers
and economy worldwide. The urgent requirement for effective
treatments has sparked an intense effort on the part of the pharmaceutical industry and shifted drug development to a new
scale of commitment and collaboration.
Received 26 June 2020; editorial decision 5 August 2020; accepted 6 August 2020; published
online August 9, 2020.
Correspondence: N. V. Vostokova, IPHARMA LLC, Moscow, Russian Federation (nv@ipharma.ru).
Clinical Infectious Diseases® 2021;73(3):531–4
© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases
Society of America. This is an Open Access article distributed under the terms of the Creative
Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/
by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any
medium, provided the original work is not altered or transformed in any way, and that the
work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
DOI: 10.1093/cid/ciaa1176
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