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All Studies   Meta Analysis    Recent:   

Phase 3 Trial of Coronavir (Favipiravir) in Patients with Mild to Moderate COVID-19

Ruzhentsova et al., SSRN, doi:10.2139/ssrn.3696907
Oct 2020  
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Hospitalization 6% Improvement Relative Risk Ventilation -150% ICU admission -51% HR for time to clinical i.. 39% Viral clearance 22% Favipiravir  Ruzhentsova et al.  EARLY TREATMENT  RCT Is early treatment with favipiravir beneficial for COVID-19? RCT 168 patients in Russia (May - June 2020) Faster recovery with favipiravir (p=0.007) c19early.org Ruzhentsova et al., SSRN, October 2020 Favorsfavipiravir Favorscontrol 0 0.5 1 1.5 2+
RCT 168 patients, 112 receiving favipiravir and 56 SOC, showing shorter time to clinical improvement and faster viral clearance with favipiravir.
risk of hospitalization, 6.0% lower, RR 0.94, p = 0.49, treatment 3 of 112 (2.7%), control 2 of 56 (3.6%), adjusted per study.
risk of mechanical ventilation, 150.0% higher, RR 2.50, p = 1.00, treatment 1 of 112 (0.9%), control 0 of 56 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
risk of ICU admission, 51.0% higher, RR 1.51, p = 0.63, treatment 3 of 112 (2.7%), control 1 of 56 (1.8%), adjusted per study.
HR for time to clinical improvement, 38.7% lower, HR 0.61, p = 0.007, treatment 112, control 56, inverted to make HR<1 favor treatment.
risk of no viral clearance, 21.9% lower, RR 0.78, p = 0.16, treatment 112, control 56, inverted to make RR<1 favor treatment, day 5 mid-recovery.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Ruzhentsova et al., 26 Oct 2020, Randomized Controlled Trial, Russia, preprint, 31 authors, study period 23 May, 2020 - 30 June, 2020, average treatment delay 3.55 days.
This PaperFavipiravirAll
Phase 3 Trial of Coronavir (Favipiravir) in patients with mild to moderate COVID-19
Tatiana A Ruzhentsova, Pavel V Chukhliaev, Daria A Khavkina, Alexander A Garbuzov, Rodion A Oseshnyuk, Tatyana N Soluyanova, Irina V Shestakova, Adel Yu Vafin, Elena P Dmitrikova, Dzhavanshir M Mustafaev, Tatiana N Domostroeva, Maria V Otpushchennikova, Konstantin A Pokrovskiy, Тatyana N Markova, Elena A Kaplun, Diana V Petina, Marina G Rusanova, Dmitriy A Bistritskiy, Natalia E Kostina, Viсtoria S Lesina, Sergey G Scherbak, Alina S Agafina, Yury F Brook, Oleg Y Bronov, Evgeny I Shults, Mikhail Y Samsonov, Emilia N Krasavina, Arkadiy V Zintchenko, Maria V Nikolskaya, Viсtoria A Razzhivina, Olga V Filon
Background Favipiravir is an antiviral drug, an inhibitor of RNA dependent RNA polymerase that is preliminarily effective against SARS-CoV-2 virus. The aim of this study was to evaluate the efficacy and safety of favipiravir for treatment of mild to moderate coronavirus disease (COVID-19). Methods We conducted an open-labeled, randomized, active-controlled multicenter trial of an oral dosage form of favipiravir in out-and hospitalized patients with mild to moderate COVID-19. The study was organized in 10 clinical centers in Russia. Eligible patients had laboratory confirmed by PCR test infection of SARS-CoV-2 and were aged 18-60 years. Patients were randomly assigned (in a 2:1 ratio) to receive either favipiravir (1800 mg BID on day 1, followed by 800 mg BID for up to 9 days), or standard of care (SOC) treatment (umifenovir + intranasal interferon alpha-2b, or hydroxychloroquine) for up to 10 days. Randomization was performed using a web-response system after stratification by COVID-19 severity, age and CT severity at enrollment. The coprimary outcomes were the time to clinical improvement and the time to viral clearance. An efficacy analysis was performed in intent-to-treat population. The safety population included all participants who received at least one dose of favipiravir or SOC. The trial is registered on ClinicalTrials.gov, identifier: NCT04501783. Findings Between May 23, 2020, and June 30, 2020, 190 patients were assessed for eligibility, of whom 168 were randomly assigned to receive either favipiravir (n = 112), or SOC (n = 56). The median time to clinical improvement was 6.0 (IQR 4•0; 9•3) days in favipiravir group and 10.0 (IQR 5•0; 21•0) days in SOC group; the median difference was 4 days (HR 1•63; 95% CI 1•14-2•34, p = 0•007). The statistically significant difference in the median time to viral clearance was observed only in the hospitalized cohort of patients: 3•0 (IQR 3•0; 3•0) vs. 5•0 (IQR 4•5; 5•5), respectively (HR 2•11; 95% CI 1•04-4•31; p = 0•038). However, the rate of viral elimination on Day 5 in the favipiravir group was significantly higher in the whole population: 81•2% vs. 67•9% respectively (RR 1•22; 05% CI 1•00-1•48; p = 0.022). The rate of clinical improvement on Day 7 in the favipiravir group was 1.5-fold higher compared to SOC: 52•7% vs. 35•8% (RR 1•50; 95% CI 1•02-2•22; p = 0•020). Favipiravir was well tolerated: most of the adverse events (AE) were mild. Any AEs were reported in 74•1% of patients in the favipiravir group vs. 60•0% in the SOC group. Among the most common adverse reactions was asymptomatic hyperuricemia, transient elevation of ALT & AST, and gastrointestinal disorders (diarrhea, nausea, abdominal pain). Interpretation Favipiravir was superior to SOC in shortening the time to clinical improvement in patients with mild to moderate COVID-19.
Favipiravir 3) and decreased oxygen saturation due to COVID-19 progression (gr. 3). § The difference was statistically significant (р < 0•0001). Table 3 : Adverse events of any cause that occurred in 5% or more patients in the Astreated population
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