Council of Scientific & Industrial Research (CSIR), and Laxai Life Sciences Hyderabad, have received regulatory approval from the Drugs Controller General of India (DCGI) to undertake a two-arm phase-II clinical trial to assess the safety and efficacy of the drug Colchicine 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 the CSIR-Indian Institute of Integrative Medicine (IIIM), Jammu.
Dr. Shekhar C Mande, Director General of CSIR, welcomed the decision on the approval granted to conduct the clinical trial on this approved drug, used to treat gout and related inflammatory conditions.
Dr. Ram Vishwakarma, advisor to DG-CSIR highlighted that colchicine in combination with standard of care will be a significant therapeutic intervention for Covid patients with cardiac co-morbidities and also for reducing pro-inflammatory cytokines, resulting in a speedier recovery.
A number of global studies have proved that cardiac complications during the course of COVID-19 infections and post-covid syndrome are leading to the loss of many lives, and it is important to look for new or repurposed drugs.
Dr. S. Chandrasekhar (Director of CSIR-IICT, Hyderabad) and Dr. DS Reddy (Director of 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 could lead to a life-saving intervention in the management of hospitalized patients. India is one of the world’s major producers of this key drug and if successful, it will be made available to the patients at an affordable cost.
Dr. Ram Upadhayay, CEO of Laxai informed that the enrollment of patients has already commenced at multiple sites across India and the trial is expected to be completed in the next 8-10 weeks. He further added that this drug can be made available to the large population of India based on the results of this trial and regulatory approval.
According to recent clinical studies published in leading medical journals states that colchicine is being associated with a significant reduction in the rates of recurrent pericarditis, postpericardiotomy syndrome, and peri-procedural atrial fibrillation following cardiac surgery and atrial fibrillation ablation.
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