Ivashchenko: AVIFAVIR for Treatment of Patients with Moderate COVID-19: Interim Results of a Phase II/III Multicenter Randomized Clinical Trial [Favipiravir]

AVIFAVIR for Treatment of Patients with Moderate COVID-19: Interim Results of a Phase II/III Multicenter Randomized Clinical Trial

Ivashchenko et al., Clin. Infect. Dis., doi:10.1093/cid/ciaa1176

Ivashchenko et al., AVIFAVIR for Treatment of Patients with Moderate COVID-19: Interim Results of a Phase II/III Multicenter.., Clin. Infect. Dis., doi:10.1093/cid/ciaa1176

Aug 2020 Source PDF

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Intermin 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. The report indicates that 75% of the control group received HCQ/CQ.

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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.

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.

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%).

risk of hospitalization, 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), 1600/600mg.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Ivashchenko et al., 9 Aug 2020, Randomized Controlled Trial, Russia, peer-reviewed, 21 authors, average treatment delay 6.7 days.

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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 Repositioning of antiviral drugs that could be effective against SARS-CoV-2 is one of..

Late treatment
is less effective

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