The Council of Scientific and Industrial Research (CSIR) in collaboration with Laxai Life Sciences has initiated Phase-II clinical trial with the anti-helminitic drug Niclosamide for the treatment of COVID-19. The trial is a multi-centric, phase-II, randomised, open-label clinical study to evaluate the efficacy, safety and tolerability of Niclosamide for the treatment of hospitalised COVID-19 patients.

Niclosamide has been extensively used in past for the treatment of tapeworm’s 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.

Dr Shekhar C Mande, Director General, CSIR expressed his happiness over the SEC recommendations to conduct this Phase II clinical trial using Niclosamide, which is a generic, affordable drug and easily available in India and therefore can be made available to our population.

Dr Ram Vishwakarma, Advisor to DG-CSIR pointed out that in a screen to identify drugs that can inhibit syncytia formation, Niclosamide was identified as a promising repurposed drug by a research group from King’s College, London, who collaborated in this project. The syncytia or fused cells observed in the lungs of patients with COVID-19 probably results from the fusogenic activity of the SARS-CoV-2 spike protein and Niclosamide can inhibit syncytia formation.

He also mentioned that independently, collaborative research between CSIR-IIIM, Jammu and NCBS, Bangalore has recently demonstrated that Niclosamide is also a potential SARS-CoV2 entry inhibitor blocking the viral entry through the pH-dependent endocytic pathway. Given these two independent experimental studies, Niclosamide has now emerged as a promising drug candidate for the clinical trial in COVID-19 patients.