CSIR, Hyderabad-based pharma firm get regulatory nod for clinical trials on COVID-19 patients with Colchicine
New Delhi: Council of Scientific & Industrial Research (CSIR), and Laxai Life Sciences Pvt. Ltd. Hyderabad, have been given the regulatory approval by DCGI to undertake a two-arm phase-II clinical trial to assess the safety and efficacy of the drug Colchicine in improvement of clinical outcomes during the treatment of COVID-19 patients. The partner CSIR institutes in this important clinical trial are the CSIR-Indian Institute of Chemical Technology (IICT), Hyderabad and CSIR-Indian Institute of Integrative Medicine (IIIM), Jammu.
Dr Shekhar C Mande, Director General of CSIR, expressed his happiness on the approval granted to conduct the clinical trial on this approved drug, used for treating gout and related inflammatory conditions. Dr Ram Vishwakarma, advisor to DG-CSIR highlighted that colchicine in combination with standard of care will be an important therapeutic intervention for Covid patients with cardiac co-morbidities and also for reducing proinflammatory cytokines, leading to faster recovery. A number of global studies have confirmed now that cardiac complications during course of COVID-19 infections and post-covid syndrome are leading to loss of many lives, and it is essential to look for new or repurposed drugs.
Dr. S. Chandrasekhar (Director CSIR-IICT, Hyderabad) and Dr. DS Reddy (Director, CSIR-IIIM, Jammu), the two partner institutes from CSIR said that they are looking forward to the outcome of this Phase II clinical efficacy trial on Colchicine, which may lead to life-saving intervention in the management of hospitalized patients. India is one of the largest producers of this key drug and if successful, it will be made available to the patients at an affordable cost.
Dr Ram Upadhayay, CEO, Laxai informed, that the enrollment of patients has already begun at multiple sites across India and the trial is likely to be completed in the next 8-10 weeks. He further added that this drug can be made available to large population of India based on the results of this trial and regulatory approval.
Recent clinical studies have reported in leading medical journals about colchicine being associated with a significant reduction in the rates of recurrent pericarditis, post-pericardiotomy syndrome, and peri-procedural atrial fibrillation following cardiac surgery and atrial fibrillation ablation.