Glenmark conducted the phase 3 clinical trial of favipiravir for COVID-19 treatment in mild to moderate 150 patients of COVID-19,its study evaluated the efficacy and safety of favipiravir plus standard supportive care, versus standard supportive care alone.
Glenmark Pharmaceuticals conducted open-label randomised, multicentre clinical trial, 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, randomised within a 48-hour window of testing RT-PCR positive for COVID-19 across seven clinical sites in India.
Favipiravir is a broad-spectrum oral antiviral drug that selectively inhibits RNA-dependent RNA polymerase (RdRp) and the viral replication phase of SARS-CoV-2 and is being studied in multiple ongoing international clinical trials.
In Glenmark Favipiravir clinical trial patients received Favipiravir tablets 3,600 mg (1,800 mg BID) (Day 1) + 1,600 mg (800 mg BID) (Day 2 or later) for up to maximum of 14 days, along with standard supportive care.Phase 3 trial( in mild (90 patients) and moderate (60 patients)) showed numerical improvements for the primary efficacy endpoint with 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 arm compared to those in the control arm (Hazard Ratio 1.367 [95%CI 0.944,1.979]; p=0.129).
Key outcomes favipiravir treatment arm over the control arm:-
1. 40 per cent faster achievement of “clinical cure” defined as the physician’s assessment of normalisation of clinical signs – temperature, oxygen saturation, respiratory rate and cough.
2. 69.8 per cent of patients in the Favipiravir treatment arm achieved clinical cure by Day 4, which was statistically significant compared to 44.9 per cent observed in the control arm (p=0.019).
3. Amongst patients who clinically deteriorated and required oxygen support, those receiving Favipiravir had a longer median time to first-time use of oxygen of five days (95%CI 1.0,6.0) versus two days (95% CI 1.0-4.0) in the control arm
Dr Zarir Udwadia, one of the Principal Investigators of this study, commented, “The results of the Indian Favipiravir study are encouraging 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 ARDS and mortality.”