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In collaboration with Laxai Life Sciences Private Ltd, the Council for Scientific and Industrial Research has initiated the phase-II clinical trial with anti-helminitic drug Niclosamide for the treatment of Covid-19, the Ministry of Science & Technology said on Sunday.
The trial is a multi-centric, phase-II, randomized, open-label clinical study to evaluate efficacy, safety and tolerability of NIclosamide for the treatment of hospitalized Covid-19 patients, the Ministry said in a statement.
Niclosamide has been extensively used in the past to treat tapeworm’s infection in adults and children. The safety profile of this drug has been tested over time and has been found safe for human consumption at different dose levels, the statement said.
Niclosamide is a generic, affordable drug and readily available in India and therefore can be made available to the broader population, said Dr Shekhar C Mande, Director General, CSIR.
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, that collaborated in this project, the statement added. 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.
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 clinical trials in Covid-19 patients, the Ministry said.
Realizing the potential of Niclosamide, efforts were initiated last year itself to undertake clinical trials, said Dr Ram Upadhayaya, CEO, Laxai. Having received approval from the drug regulator, the clinical trial has been initiated this week at different sites and it is expected that the trial will be completed within 8-12 weeks.
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