The American Journal of Translational Research has published successful results of the Phase 3 clinical trial of Coronavir (INN: favipiravir). This study aimed to evaluate the efficacy and safety of favipiravir for treatment of mild to moderate COVID-19 in outpatients and hospitalized patients.
In an open-label, randomized, active-controlled clinical trial involving 168 patients with mild to moderate COVID-19, Coronavir was found to reduce the median time of clinical improvement onset (according to the WHO Orderly Clinical Improvement Scale) in hospitalized patients by 4 days and in the outpatient cohort by 8 days. It is worth noting, that at day 7 clinical improvement occurred in more than 50% of patients in the Coronavir group, which is 1.5 times higher than the control group, which received standard of care (SOC) treatment (umifenovir in combination with intranasal interferon alpha-2b, or hydroxychloroquine). Administration of Coronavir also resulted in statistically significant, more frequent elimination of SARS-CoV-2 coronavirus from oropharyngeal mucosa in the early stage of the disease. On day 5 after the therapy start, the virus was eliminated in 81.2% against 67.9% in the control group.
Another important study result – Coronavir’s favorable safety profile. It was mostly well tolerated by patients, with a few adverse reactions: asymptomatic hyperuricemia (observed in 41.7% of patients), mostly mild, which resolved after therapy completion, transient elevation of ALT and AST, and mild gastrointestinal disorders.
Mikhail Samsonov, Medical Director of R-Pharm, PhD: «The published clinical study demonstrated the ability of favipiravir to suppress the viral infection in the early stages and prevent further disease progression. We are also pleased that the drug is now available to patients in Kazakhstan – its authorization can bring significant benefits to the country’s healthcare system in its fight against COVID-19″.
The efficacy and safety of favipiravir (active substance of Coronavir) were also established earlier in the course of clinical trials, the completion of which was announced in late September 2020 by the Japanese corporation Fujifilm Holdings.
In a randomized, placebo-controlled, blind, comparative study involving 156 participants, clinical improvement in patients receiving favipiravir took an average of 11.9 days, while in the comparison group receiving placebo — 14.7 days. This difference was considered statistically significant (p = 0.0136), while the risk ratio was 1.593 (95% CI 1.024-2.479). This allows classifying the study results as data of high degree of evidence.