New Delhi: The CSIR, in collaboration with Laxai Life Sciences, has initiated Phase 2 clinical trial of anti-helminitic drug Niclosamide for treatment of Covid-19.
The trial is a multi-centric, randomised, open label clinical study to evaluate efficacy, safety and tolerability of Niclosamide for the treatment of hospitalized Covid-19 patients, it said.
Niclosamide has been extensively used in past for treatment of tapeworm infection in adults as well as children. The safety profile of this drug has been tested over time and has been found safe for human consumption at different dose levels.
CSIR Director General Shekhar C. Mande expressed his happiness over the SEC recommendations to conduct this Phase II clinical trial using Niclosamide, which is a generic and affordable drug, easily available in India, and therefore, can be made available to the population.
CSIR-IICT Hyderabad Director Srivari Chandrashekhar highlighted that the Active Pharmaceutical Ingredient (API) is being made by Laxai Life Sciences based on improved technology developed at the IICT and the lab is a partner in this important clinical trial which could provide cost effective therapeutic options for patients if trial is successful.
Laxai CEO, Dr Ram Upadhayaya, said that realising the potential of Niclosamide, efforts were initiated last year itself to undertake clinical trials. Having received approval from drug regulator, the clinical trial has been initiated this week at different sites and is expected to be completed within 8-12 weeks. Based on successful clinical evidence generated during clinical trials in Indian studies, emergency use authorisation may be sought so that more treatment options are available to COVID-19 patients, he said.