CSIR, Laxai Life Sciences get nod to conduct clinical trials of colchicine on COVID-19 patients

The partner CSIR institutes in this clinical trial are the CSIR-Indian Institute of Chemical Technology (IICT), Hyderabad, and the CSIR-Indian Institute of Integrative Medicine (IIIM), Jammu.

By Newsmeter Network  Published on  12 Jun 2021 11:29 AM GMT
CSIR, Laxai Life Sciences get nod to conduct clinical trials of colchicine on COVID-19 patients

Hyderabad: The Drugs Controller General of Idia (DCGI) has given permission to the Council of Scientific and Industrial Research (CSIR) and Laxai Life Sciences Pvt. Ltd, Hyderabad, to undertake a two-arm Phase II clinical trial to assess the safety and efficacy of the drug Colchicine.

The partner CSIR institutes in this clinical trial are the CSIR-Indian Institute of Chemical Technology (IICT), Hyderabad, and CSIR-Indian Institute of Integrative Medicine (IIIM), Jammu.

The drug Colchicine is 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-19 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 COVID-19 infections and post-COVID syndrome are leading to the loss of many lives and it is essential to look for new or repurposed drugs.

Dr. S. Chandrasekhar, the director of Hyderabad's CSIR-IICT, and Dr. D.S Reddy, the director of CSIR-IIIM, Jammu, said they are looking forward to the outcome of the 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.

Meanwhile, the CEO of Laxai, Dr. Ram Upadhayay, said the enrollment of patients has already started at multiple sites across India and the trial is likely to be completed in the next eight-10 weeks. He further added that this drug can be made available to India's large population based on the results of this trial and regulatory approval.

Recent clinical studies in leading medical journals have reported that colchicine is 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.


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