tetano
Editor, Senior Moderator
Am J Transl Res
. 2021 Nov 15;13(11):12575-12587.
eCollection 2021.
Phase 3 trial of coronavir (favipiravir) in patients with mild to moderate COVID-19
Tatiana A Ruzhentsova[SUP] 1 [/SUP], Rodion A Oseshnyuk[SUP] 2 [/SUP], Tatyana N Soluyanova[SUP] 3 [/SUP], Elena P Dmitrikova[SUP] 4 [/SUP], Dzhavanshir M Mustafaev[SUP] 5 [/SUP], Konstantin A Pokrovskiy[SUP] 6 [/SUP], Тatyana N Markova[SUP] 7 [/SUP], Marina G Rusanova[SUP] 8 [/SUP], Natalia E Kostina[SUP] 9 [/SUP], Alina S Agafina[SUP] 10 [/SUP], Yuri F Brook[SUP] 11 [/SUP], Oleg Y Bronov[SUP] 11 [/SUP], Evgeny I Shults[SUP] 12 [/SUP], Olga V Filon[SUP] 13 [/SUP]
Affiliations
Abstract
Favipiravir has demonstrated efficacy against the SARS-CoV-2 virus in several preliminary studies. This study aimed to evaluate the efficacy and safety of favipiravir for treatment of mild to moderate COVID-19 in outpatients and hospitalized patients. We conducted an open-label, randomized, active-controlled trial of a generic form of favipiravir in patients with COVID-19 confirmed by PCR-test. Eligible patients (18-60 years) after stratification 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. The co-primary outcomes were the time to clinical improvement and the time to viral clearance. Among 190 patients assessed for eligibility 168 were randomized to favipiravir (n=112) or to SOC (n=56) group. The median time to clinical improvement was 6.0 days (IQR 4.0; 9.3) in the favipiravir group and 10.0 (IQR 5.0; 21.0) days in the 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 for hospitalized patients: 3.0 (IQR 3.0; 3.0) days in the favipiravir group vs. 5.0 (IQR 4.5; 5.5) days in the SOC group (HR 2.11; 95% CI 1.04-4.31; P=0.038). The rate of viral elimination on Day 5 in the favipiravir group was significantly higher than in SOC group: 81.2% vs. 67.9% (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 than in SOC group: 52.7% vs. 35.8% (RR 1.50; 95% CI 1.02-2.22; P=0.020). Favipiravir was well-tolerated and the most common adverse reactions were asymptomatic hyperuricemia, transient elevation of ALT & AST, and mild gastrointestinal disorders. Favipiravir was superior to the SOC in shortening the time to clinical improvement in patients with mild to moderate COVID-19.
Keywords: COVID-19; SARS-CoV-2; coronavirus; favipiravir.
. 2021 Nov 15;13(11):12575-12587.
eCollection 2021.
Phase 3 trial of coronavir (favipiravir) in patients with mild to moderate COVID-19
Tatiana A Ruzhentsova[SUP] 1 [/SUP], Rodion A Oseshnyuk[SUP] 2 [/SUP], Tatyana N Soluyanova[SUP] 3 [/SUP], Elena P Dmitrikova[SUP] 4 [/SUP], Dzhavanshir M Mustafaev[SUP] 5 [/SUP], Konstantin A Pokrovskiy[SUP] 6 [/SUP], Тatyana N Markova[SUP] 7 [/SUP], Marina G Rusanova[SUP] 8 [/SUP], Natalia E Kostina[SUP] 9 [/SUP], Alina S Agafina[SUP] 10 [/SUP], Yuri F Brook[SUP] 11 [/SUP], Oleg Y Bronov[SUP] 11 [/SUP], Evgeny I Shults[SUP] 12 [/SUP], Olga V Filon[SUP] 13 [/SUP]
Affiliations
- PMID: 34956474
- PMCID: PMC8661194
Abstract
Favipiravir has demonstrated efficacy against the SARS-CoV-2 virus in several preliminary studies. This study aimed to evaluate the efficacy and safety of favipiravir for treatment of mild to moderate COVID-19 in outpatients and hospitalized patients. We conducted an open-label, randomized, active-controlled trial of a generic form of favipiravir in patients with COVID-19 confirmed by PCR-test. Eligible patients (18-60 years) after stratification 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. The co-primary outcomes were the time to clinical improvement and the time to viral clearance. Among 190 patients assessed for eligibility 168 were randomized to favipiravir (n=112) or to SOC (n=56) group. The median time to clinical improvement was 6.0 days (IQR 4.0; 9.3) in the favipiravir group and 10.0 (IQR 5.0; 21.0) days in the 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 for hospitalized patients: 3.0 (IQR 3.0; 3.0) days in the favipiravir group vs. 5.0 (IQR 4.5; 5.5) days in the SOC group (HR 2.11; 95% CI 1.04-4.31; P=0.038). The rate of viral elimination on Day 5 in the favipiravir group was significantly higher than in SOC group: 81.2% vs. 67.9% (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 than in SOC group: 52.7% vs. 35.8% (RR 1.50; 95% CI 1.02-2.22; P=0.020). Favipiravir was well-tolerated and the most common adverse reactions were asymptomatic hyperuricemia, transient elevation of ALT & AST, and mild gastrointestinal disorders. Favipiravir was superior to the SOC in shortening the time to clinical improvement in patients with mild to moderate COVID-19.
Keywords: COVID-19; SARS-CoV-2; coronavirus; favipiravir.