New Delhi: In a key development, CSIR and Hyderabad-based Laxai Life Sciences Pvt Ltd have been given regulatory approval by 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 for the treatment of Covid-19 patients.
If successful, Colchicine will be made available to the patients at an affordable cost, as India is one of the largest producers of this key drug.
As a number of global studies have confirmed that cardiac complications during the course of Covid-19 infections and post-Covid syndrome are leading to the loss of many lives, Colchicine, Which is used for treating gout and related inflammatory conditions is expected to be an important therapeutic intervention for Covid patients with cardiac co-morbidities.
The CSIR-Indian Institute of Chemical Technology (IICT), Hyderabad and CSIR-Indian Institute of Integrative Medicine (IIIM), Jammu are the partner institutions in this clinical trial.
Dr Ram Vishwakarma, the 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 pro-inflammatory cytokines, leading to faster recovery.
Dr S. Chandrasekhar (Director CSIR-IICT, Hyderabad) and Dr D.S. 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.
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 a 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.