Pune: Phase 3 clinical trials in mild to moderate COVID-19 patients administered with Favipiravir have reported 40 per cent faster achievement of clinical cure and 28.6 per cent faster viral clearance as compared to those patients under normal treatment.
The clinical trials were conducted across seven clinical sites in India. The open-label randomised and multi-centre clinical trials were conducted in 150 patients for evaluating the efficacy and safety of Favipiravir in addition to the standard supportive care against only standard supportive care in mild to moderate patients, randomized within a 48-hour window of testing RT-PCR positive for COVID-19.
India’s top drug regulator has granted permission to antiviral drug Favipiravir for ‘restricted emergency use’ in mild to moderate cases of COVID-19 in the country. After this permission, Glenmark Pharmaceuticals received manufacturing and marketing approval from the Drug Controller General of India (DCGI). Later, the company had announced the launch of the first oral Favipiravir in the brand name ‘FabiFlu’.
Results of phase 3 trial showed 28.6 per cent faster viral clearance in the overall population as measured by the median time until cessation of oral shedding of virus in the Favipiravir treatment against the normal treatment.
Based on the physician’s assessment of normalisation of clinical signs – temperature, oxygen saturation, respiratory rate and cough – a 40 per cent faster achievement of ‘clinical cure’ was achieved in the Favipiravir treatment (3 days) against the normal treatment (5 days).
During the trials, 69.8 per cent of patients receiving the Favipiravir treatment achieved clinical cure by Day 4 which was statistically significant compared to 44.9 per cent patients observed in the normal treatment.
Amongst patients who clinically deteriorated and required oxygen support while receiving Favipiravir treatment had a longer median time to first-time use of oxygen of 5 days against the 2 days of time required in the normal treatment.
Dr Zarir Udwadia, one of the Principal Investigators of this study said, “The results are encouraging. The trial was performed with a sense of urgency, yet scientific principles were not sacrificed. 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.”