The Council of Scientific and Industrial Research (CSIR) in collaboration with Laxai Life Sciences began the phase-II clinical trials of the Niclosamide drug on Sunday for treating the coronavirus disease (Covid-19). According to a press release issued by the ministry of science and technology, the clinical trial is a multi-centric, randomised, open-label clinical study to evaluate the efficacy, safety and tolerability of the drug for treating hospitalised Covid-19 patients.
The ministry pointed out that Niclosamide has been extensively used in the past for treating tapeworm in children and adults. The drug’s safety profile has been tested over time and has found to be safe for human consumption at different dose levels. News agency PTI reported on Thursday that Niclosamide was also used for treating patients during the SARS outbreak of 2003-04 and is currently a part of the World Health Organization’s (WHO’s) list of essential medicines.
Dr Shekhar C Mande, the Director general (DG) of the CSIR expressed happiness over the subject expert committee’s (SEC’s) recommendations to conduct phase-II clinical trials using Niclosamide, which is generic, affordable and easily available in India, the release said.
“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,” Dr Ram Vishwakarma, advisor to the CSIR DG said.
Dr Vishwakarma cited a collaborative research work between CSIR-IIIM andJammu and the National Center For Biological Sciences (NCBS), Bengaluru which showed that Niclosamide was a potential SARS-CoV-2 entry inhibitor blocking the viral entry through pH-dependent endocytic pathway.
Dr Ram Upadhayaya, the chief executive officer (CEO) of Laxai, meanwhile, said considering the potential of Niclosamide, efforts had started in 2020 to undertake clinical trials of the anti-helminthic drug. The science ministry’s release also stated the clinical trial has been initiated at different sites and is expected to be completed within 8-12 weeks.
However, Niclosamide is not the only drug which the Centre is evaluating for treating the coronavirus disease.
On May 17, India rolled out 2-DG, developed by the Defence Research and Development Organisation (DRDO) in collaboration with Hyderabad-based Dr Reddy’s Laboratories (DRL). And on June 1, the DRDO said that 2-DG should be prescribed as early as possible by doctors for moderate to severe Covid-19 patients for a maximum duration of up to 10 days.