RDIF and ChemRar Launch Final Stage of Favipiravir Clinical Trial –
Median elimination of the virus in four days compared to nine days with standard therapy, according to the study involving 60 patients
– Efficacy of the drug is above 80%, a criterion of a drug with high antiviral activity
Russia’s Ministry of Health
has approved the start of the final stage of clinical trials involving 330 patients, with selection of participants currently underway
MOSCOW,
May 22, 2020 /PRNewswire/
The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, and the ChemRar Group
today announce the start of the final stage of the multicenter randomized open comparative clinical trial of the drug Favipiravir on patients hospitalized with COVID-19.
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.
RDIF and ChemRar have applied to the Russian Ministry of Health for the accelerated registration of Favipiravir in accordance with the Russian Government’s Decree No. 441 of 3 April 2020.
The first stage of the trials
has already been completed.
It lasted ten days and involved 60 patients with coronavirus infection with moderate illness.
- 40 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.
Kirill Dmitriev,
CEO of the Russian Direct Investment Fund, said:
We continue to receive promising data during the clinical trials of Favipiravir.
At least 85% of patients in the control groups completely recovered from coronavirus within 10 days after the start of the treatment with the drug.
We expect a positive final result of the trial, which will enable us to complete the registration procedure for the drug in Russia and roll out full-scale production and delivery to medical institutions across the country
Latest data show above 80% efficacy for favipiravir in COVID-19, say R