RDIF and a group of companies “Chemrar” announced the transition to the final phase multicenter randomized comparative open clinical study of favipiravir patients admitted with COVID-19. The corresponding resolution of the Ministry of health was received on 21 may.
In the final part of the study the group of participants will be expanded from 60 to 330 people. Thus, the study of the drug will cover patients in 30 centres in 9 regions.
Was previously completed phase I study (10 days therapy), with the participation of 60 patients hospitalized with coronavirus infection (COVID-19) moderate, 40 of them received therapy with favipiravir and 20 people of control group were on standard therapy. According to the results of the first phase confirmed the safety of favipiravir was not revealed any new side effects.
Efficacy of the drug was above the critical level of 80%. In 68% of patients who took favipiravir, the body temperature was normalized earlier (on day 3) than in the control group (on day 6). On average, the liberation of the body from the virus as a result of the use of favipiravir happened for 4 days, while in the group of standard therapy, the average duration is 9 days.
For the first 4 days of treatment 65% of patients of the 40 people who took favipiravir had a negative test for the coronavirus that it is 2 times more than in standard group therapy. To 10 day the number of patients with a negative test has reached 35 people out of 40.