The trial will evaluate efficacy, safety and tolerability of NIclosamide for hospitalized Covid-19 patients

The Council of Scientific & Industrial Research (CSIR) in collaboration with 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, phase-II, randomized, open label clinical study to evaluate efficacy, safety and tolerability of NIclosamide for the treatment of hospitalized Covid-19 patients, said a statement by the Ministry of Science and Technology on Sunday.

Niclosamide has been extensively used in the 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, the statement added.

The ministry's statement also highlighted what those associated with the project had to say about the development.

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

Advisor to DG-CSIR Ram Vishwakarma, who collaborated in this project, pointed out that Niclosamide was identified as a promising repurposed drug by a research group from King’s College, London.

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 pH dependent endocytic pathway, Vishwakarma argued.

He substantiated that given these two independent experimental studies, Niclosamide has now emerged as a promising drug candidate for clinical trial in Covid-19 patients.

Director CSIR-IICT Hyderabad Srivari Chandrashekhar highlighted that the Active Pharmaceutical Ingredient (API) is being made by Laxai Life Sciences based on improved technology developed at IICT and the lab is a partner in this important clinical trial which could provide cost effective therapeutic options for patients if the trial is successful.

CEO Laxai Ram Upadhayaya informed that realizing the potential of Niclosamide, efforts were initiated last year itself to undertake clinical trials.

Having received approval from the drug regulator, the clinical trial has been initiated this week at different sites and is expected that the trial will be completed within 8-12 weeks, Upadhyaya said.

Based on successful clinical evidence generated during clinical trials in Indian studies, emergency use authorization may be sought so that more treatment options are available to COVID-19 patients, he noted.