New Delhi: The Council of Scientific and Industrial Research (CSIR) and Hyderabad’s Laxai Life Sciences Private Limited have been given the 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 colchicine drug 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.
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CSIR Director General Dr Shekhar C. Mande expressed his delight on the approval granted to conduct the clinical trial on this approved drug, which is used for treating gout and related inflammatory conditions.
CSIR Director General’s Advisor Dr Ram Vishwakarma highlighted that colchicine in combination with standard of care will be an important therapeutic intervention for the Covid patients with cardiac co-morbidities and also for reducing pro-inflammatory cytokines, leading to faster recovery.
The DCGI nod comes as a number of global studies have confirmed now that cardiac complications during course of the 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 D.S. Reddy (Director, CSIR-IIIM, Jammu) - the two partner institutes from CSIR - said 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 hospitalised 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,” said a release issued by the Ministry of Science and Technology.
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Laxai CEO Dr Ram Upadhayay on his part 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 eight to ten weeks.
“This drug can be made available to large population of India based on the results of this trial and regulatory approval,” he added.
The Ministry of Science and Technology said 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.