The final stage of clinical trials of the “Favipiravir” drug will be held in Bashkortostan.
The Russian Direct Investment Fund (RDIF), the sovereign fund of the Russian Federation, and the ChemRar group of companies have announced the final stage of a multicenter randomized, open comparative clinical trial of the Favipiravir drug in patients hospitalized with COVID-19.
On May 21, the Russian Ministry of Health permitted to proceed to the final part of the clinical studies, expanding the patient group from 60 to 330 people and involving new scientific and medical centers.
The drug testing will be continued and will cover patients in 30 centers in 9 regions of the Russian Federation, including the Republic of Bashkortostan.
Previously, stage I of the study (10 days of therapy) was completed in 60 patients hospitalized with the coronavirus infection (COVID-19) of moderate severity, 40 of them received Favipiravir therapy, and 20 people from the control group had standard treatment.
According to the results of stage I, Favipiravir demonstrated safety, no new, previously non-reported side effects, and the efficacy was above a threshold level of 80%, which is a criterion for a drug with high antiviral activity.
According to the results of the first four days of treatment, 65% of 40 patients taking Favipiravir had a negative test for the coronavirus, which is 2 times higher than in the standard therapy group. By day 10, the number of patients with a negative test reached 35 out of 40.
As noted by the General Director of the Russian Direct Investment Fund (RDIF) Kirill Dmitriev, at least 85% of patients in the control groups completely recovered from the coronavirus within ten days after the start of the drug-taking. “We are counting on a positive final result, which will allow us to complete the registration procedures of the drug in the Russian Federation and begin the full-scale launch of production and delivery of the drug to medical institutions across the country,” he said.