Glenmark Pharmaceuticals Limited announced top-line results from a Phase 3 clinical trial in mild to moderate COVID-19 patients conducted across seven clinical sites in India. The open-label randomized, multicenter clinical trial, conducted in 150 patients, evaluated the efficacy and safety of Favipiravir plus standard supportive care (Favipiravir treatment arm), versus standard supportive care alone (control arm), in mild to moderate patients, randomized within a 48-hour window of testing RT-PCR positive for COVID-19. 69.8% of patients in the Favipiravir treatment arm achieved clinical cure by Day 4, which was statistically significant compared to 44.9% observed in the control arm. Glenmark’s Favipiravir was well tolerated with no serious adverse events (SAEs) or deaths in the Favipiravir treated arm.
Dr Zarir Udwadia, one of the Principal Investigators of this study, commented, “The results of the Indian Favipiravir study are encouraging. I have had a chance to independently view the initial results and they are encouraging. Patients randomised to Favipiravir seemed to have a faster clinical cure, and more importantly, faster viral clearance than those randomized to the routine care group. I feel we have enough evidence to consider using Favipiravir in symptomatic COVID-19 patients who have mild to moderate infection.” Dr Monika Tandon, Vice-President & Head (Clinical Development), Global Specialty/Branded Portfolio said, “We are encouraged with the top-line results and these indicate that early treatment with Favipiravir may improve clinical outcomes for mild to moderate patients and could potentially prevent patients from progressing to acute respiratory distress syndrome (ARDS) and mortality.
