Glenmark Pharmaceuticals announced results of its FAITH combination trial with antivirals Umifenovir and Favipiravir for the treatment of moderate hospitalized COVID-19 patients. This was the second clinical study after the successful Favipiravir monotherapy trial earlier this year that led the company to receiving the Emergency Use Authorisation for Favipiravir.
This second study titled the FAITH trial evaluated the possible superiority of the combination's efficacy against Favipiravir monotherapy.
As per the results that Glenmark today presented to the regulator, the study showed no superior clinical outcomes with the addition of Umifenovir.
The FAITH study enrolled a total of 158 hospitalized patients with moderate COVID-19 in India. The study's primary end point (clinical outcome measured) was time taken from randomization to clinical cure, defined as resolution of baseline clinical signs and symptoms of COVID-19 infection and at least 2 point improvement on WHO Ordinal Scale for Clinical Improvement, within a time frame of 28 days. Median time to clinical cure improved by only 1 day (7 as compared to 8) in patients who received the two antiviral combination, which was not statistically significant and did not justify adding two antiviral agents.
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