The Mumbai-based company Glenmark Pharmaceuticals said that it has initiated Phase 3 clinical trials on antiviral drug Favipiravir to check its effectiveness on COVID-19 patients in India. Last month, The company received approval from Drug Controller General of India (DCGI) to conduct clinical trials of Favipiravir antiviral tablets for the treatment of deadly corona virus.
By initiating the Phase 3 clinical trials on Favipiravir, Glenmark Pharmaceuticals has become the first in India to conduct trial for COVID-19 patients, it said in a statement. Over ten leading government and private hospitals are being enrolled for the study, company further added. Glenmark estimates study completion by July or August 2020.
150 subjects with mild to moderate COVID-19 symptoms will be randomised in the study in a 1:1 ratio to Favipiravir with standard supportive care or standalone standard supportive care. The duration of the treatment is a maximum of 14 days and the total study duration will be a maximum of 28 days from randomisation, as per the approved clinical trial protocol.
Glenmark Pharmaceuticals Vice President & Head Clinical Development, Global Specialty/Branded Portfolio Monika Tandon said, “Several health and medical experts, both in and outside of Glenmark are eager to see the effect that Favipiravir has on COVID-19 cases. We believe the study results will be significant as there is currently no effective treatment for the virus. The data we get from these trials will point us in a clearer direction with regard to COVID-19 treatment and management.”
The company’s main object is to launch a treatment for COVID-19 patients so as to stop spread of the pandemic, according to Glenmark.
