On 21 May 2020, the Ministry of Health of the Russian Federation approved the launch of the final stage, which will involve 330 patients compared to 60 during the initial stage, as well as additional research and medical centers. In total, 30 medical centers in nine Russian regions will conduct studies at the final stage.
The first stage of the trials has already been completed. It lasted 10 days and involved 60 patients with coronavirus infection with moderate illness. Forty people received Favipiravir treatment and the other 20 patients from the control group were on standard therapy. According to the results of the first stage, Favipiravir demonstrated safety with no new or previously unreported side effects detected. The drug’s efficacy was above a threshold of 80%, which is the criterion for a drug with high antiviral activity. The body temperature of 68% of patients taking Favipiravir returned to normal earlier (on the third day) than in the control group (on the sixth day). On average, complete elimination of the virus from the body as a result of Favipiravir treatment occurred in four days, while in the standard therapy group this process took nine days.
Following the first four days of treatment, 65% of the 40 patients who took Favipiravir tested negative for coronavirus, which is twice as many as in the standard therapy group. By day 10, the number of patients whose tests returned negative results reached 35 out of 40.
The first Russian direct antiviral drug for COVID-19 with proven clinical efficacy has been named Avifavir.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said:
“Avifavir shows better results compared to other drugs that are currently being tested in Russia and abroad. RDIF and ChemRar are cooperating with both leading medical institutions and state regulatory bodies. We look forward to receiving approval for the production of Avifavir in the near future.”