Glenmark to commence clinical trial for combination of Favipiravir and Umifenovir

Glenmark also continues to conduct phase 3 clinical trial for Favipiravir as a COVID-19 monotherapy option

Glenmark Pharmaceuticals has announced a new randomized, open-label study to test the combined efficacy of two antiviral drugs Favipiravir and Umifenovir as a potential COVID-19 treatment strategy. The two antiviral drugs have different mechanism of action, and their combination may demonstrate improved treatment efficacy by effectively tackling high viral loads in patients during early stage of disease.

The new combination clinical trial will be called FAITH - (FA vipiravir plus Um I fenovir (efficacy & safety) T rial in Indian H ospital setting). 158 hospitalized patients of moderate COVID-19 infection will be enrolled in the combination study and randomized in two groups: one group receiving Favipiravir and Umifenovir (with standard supportive care); and one group receiving Favipiravir along with standard supportive care. Patients in the arm receiving the drug will receive Faviprivir 1800mg bid and Umifenovir 800 mg bid on Day 1. Thereafter patients would receive Faviprivir 800mg bid and Unifenovir 800mg bid for the remaining course of the treatment. Duration of treatment will be 14 days and patients will be discharged after clinical cure and two consecutive negative tests for COVID-19 based on RT-PCR.

Simultaneously, Glenmark is also conducting phase 3 clinical trials of Favipiravir as a COVID-19 monotherapy option with 150 patients, enrolled from 9 leading government and private hospitals across the country. So far 30 patients have been randomised. The monotherapy phase 3 clinical trial results are expected by July/August 2020. Glenmark was the first pharmaceutical company to receive approval from drug regulator DCGI to conduct Favipiravir clinical trials against COVID-19 in India.

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