Council of Scientific & Industrial Research (CSIR), in collaboration with Hyderabad based Laxai Life Sciences Pvt. Ltd., has initiated Phase-II clinical trial with 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 hospitalised patients. It was extensively used in the past for treatment of tapeworm’s infection in adults and children. The safety profile of this drug has been tested over time and has been found to be safe at different dose levels.
CSIR Director-General Shekhar C. Mande expressed happiness over SEC recommendations to conduct the Phase II clinical trial using Niclosamide, which is generic, affordable and easily available in India and therefore can be made available to the population, said a press release on Sunday.
Niclosamide was identified as a promising repurposed drug by research group from King’s College, London, which collaborated on this project, in a screen to identify drugs that can inhibit ‘syncytia’ or fused cells observed in lungs of patients with COVID formation and this drug was found to be inhibiting the formation, said adviser to D-G, Ram Vishwakarma.
S. Chandrashekhar, director of CSIR-Indian Institute of Chemical Technology, also based here, said the Active Pharmaceutical Ingredient (API) made by Laxai Life Sciences was based on improved technology developed at IICT and is a partner in this important clinical trial.
Independently, collaborative research between CSIR-Indian Institute of Integrative Medicine, Jammu, and National Centre for Biological Sciences (NCBS), Bengaluru ,has demonstrated that Niclosamide is also a potential SARS-CoV2 entry inhibitor, blocking the viral entry through ‘pH dependent endocytic pathway’.
Laxai CEO Ram Upadhayaya said clinical trial has been initiated this week at different sites and will be completed within 8-12 weeks. Based on successful clinical evidence generated during clinical trials, emergency use authorisation may be sought so that more treatment options are available to COVID patients, the release added.
