Glenmark Pharma announced results of its “FAITH” combination trial with antivirals umifenovir and favipiravir for the treatment of moderate hospitalised COVID-19 patients.
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 hospitalised patients with moderate COVID-19 in India. The study’s primary endpoint (clinical outcome measured) was time taken from randomisation 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. The median time to clinical cure improved by only one day (7 as compared to 8) in patients who received the two antiviral combinations, which was not statistically significant and did not justify adding two antiviral agents.
Commenting on the trial’s findings, Dr Monika Tandon, Senior Vice President & Head, Clinical Development, Global Specialty/Branded Portfolio, Glenmark Pharmaceuticals, said, “These latest findings confirm that the addition of Umifenovir does not show any incremental benefit in clinical outcomes. Thus favipiravir therapy along with supportive care remains a suitable and effective choice for mild to moderate COVID-19 infection.”