New Delhi: Domestic pharma giant Glenmark pharmaceuticals on Thursday announced the positive outcomes from a Phase 3 clinical trial conducted across seven clinical sites in India, where COVID-19 patients administered with Favipiravir reported faster clinical cure and viral clearance as compared to COVID-19 patients (mild to moderate) with routine care.
The company said that patients randomised to Favipiravir treatment arm reported faster clinical cure and faster viral clearance than those randomized to the routine care group.
"Results from the Phase 3 trial 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," stated the company statement.
The study highlighted the efficacy and benefit of Favipiravir treatment arm over the control arm.
At least 40 per cent faster achievement of 'clinical cure' defined as the physician's assessment of normalization of clinical signs - temperature, oxygen saturation, respiratory rate and cough with a statistically significant reduction in median time to clinical cure in the Favipiravir treatment arm (three days), compared to the control arm (five days).
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About 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.
"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 versus two days in the control arm."
Methodology
The open-label randomized, multicenter clinical trial was conducted in 150 patients to evaluate the efficacy and safety of 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.
Patients received Favipiravir tablets 3,600 mg on day 1, followed by 800 mg twice daily to a maximum of 14 days, along with standard supportive care. Randomization was stratified based on disease severity into mild (90 patients) and moderate (60 patients).
Last month, ANI reported that country's top drug regulator has granted permission to anti-viral drug favipiravir for "restricted emergency use" in mild to moderate cases of COVID-19 in India. Following which, the Glenmark Pharmaceuticals received manufacturing and marketing approval from the Drug Controller General of India (DCGI).
The domestic pharma giant announced the launch of the first oral Favipiravir in the brand name 'FabiFlu'.
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Dr Zarir Udwadia, one of the Principal Investigators of this study, commented, "The results of the Indian Favipiravir study are encouraging. The trial was performed with a sense of urgency considering the gravity of the pandemic, yet scientific principles were not sacrificed. I have had a chance to independently view the initial results and they are encouraging."
"Patients randomised to Favipiravir seemed to have the faster clinical cure, and more importantly, faster viral clearance than those randomized to the routine care group. I eagerly await the final analysis and results from other ongoing studies from across the globe. Till then, I feel we have enough evidence to consider using Favipiravir in symptomatic COVID-19 patients who have mild to moderate infection," Udwadia added.
Glenmark plans to submit the clinical trial data for publication in a peer-reviewed journal in the coming weeks.
ANI
