Mumbai Hospital-led Phase 3 Clinical Trial Reveals the Efficacy of Favipiravir
Targeting Mild to Moderate COVID-19 Patients in India
The latest news out of India
is promising as the results of this Phase 3 clinical trial sponsored by Glenmark Pharmaceuticals and led by the Breach Candy Hospital Mumbai
were published online in The International Journal of Infectious Diseases (IJID).
This is a globally reputed peer-reviewed, pubmed indexed, open access journal with monthly issues,
published by the International Society for infectious Diseases in the Untied States.
These findings
will appear in the print edition as well.
The publication of the study
is titled “Efficacy and Safety of Favipiravir, an oral RNA-Dependent RNA Polymerase Inhibitor, in Mild-to-Moderate COVID-19:
A Randomized,
Comparative,
Open-Labe,
Multicenter,
Phase 3 Clinical Trial” authored by Dr. Zarir F. Udwadia and co-authors.
The Study
The Phase 3 study
was conducted in 150 patients as part of a randomized, open label, multicenter effort to investigate 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.
Glenmark Pharmaceutical reports that
the drug offered multiple treatment
benefits including faster time to clinical cure and it actually contributed to the delay in the need for supportive oxygen therapy.
Moreover, the investigators, led by Dr. Zarir F. Udwadia, MD, FRCP, FCCP, Breach Candy Hospital Mumbai,
that patients with COVID-19 with moderate symptoms were discharged from the hospital earlier than those patients that did not receive Favipiravir, with the median time to clinical cure reduced by 2.5 days compared with the control group.
Patients in the Glenmark clinical trial
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.
Randomization was stratified based on disease severity into mild and moderate.
The drug was well tolerated with no serious adverse events (SAEs) or deaths in the Favipiravir arm of the study.