DCGI gives nod to phase-II clinical trial of Colchicine by Hyderabad-based firm for Covid treatment

HYDERABAD: The Council of Scientific & Industrial Research (CSIR) and Hyderabad-based pharmaceutical firm, Laxai Life Sciences, have been given the regulatory approval by Drug Controller General India (DCGI) to undertake a two-arm phase-II clinical trial to assess safety and efficacy of the drug Colchicine, in improvement of clinical outcomes during the treatment of COVID-19 patients. 

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.

Dr Ram Vishwakarma, advisor to DG-CSIR highlighted that colchicine in combination with the standard of care will be an important therapeutic intervention for Covid patients with cardiac co-morbidities and 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.

IICT Director, Dr. S. Chandrasekhar and IIIM Director, Dr. DS Reddy, 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. The partner CSIR institutes in this clinical trial are the Indian Institute of Chemical Technology(IICT), Hyderabad and Indian Institute of Integrative Medicine(IIIM), Jammu.

India is one of the largest producers of Colchicine and if the trial proves successful, it would be 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.

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.