DCGI Approves Phase 2 Clinical Trial Of Repurposed Drug 'Colchicine' On COVID-19 Patients
The Drug Controller General of India has given its approval to a proposal by the Council of Scientific and Industrial Research (CSIR) and Hyderabad-based Laxai Life Sciences Private Limited to conduct clinical trials of the drug Colchicine on COVID-19 patients.
Colchicine is an approved drug used in the treatment of gout and related inflammatory conditions.
The Indian drug regulator has given a go ahead to CSIR and Laxai Life to undertake a two-arm phase-II clinical trial to assess the safety and efficacy of the drug Colchicine in improvement of clinical outcomes during the treatment of COVID-19 patients.
CSIR-Indian Institute of Chemical Technology (IICT), Hyderabad and CSIR-Indian Institute of Integrative Medicine (IIIM), Jammu are the partner CSIR institutes in the clinical trial, according to a Science and Technology Ministry release.
According to the release, Dr Ram Vishwakarma, advisor to DG-CSIR, said 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 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, the release said.
India is one of the largest producers of Colchicine and if successful, it will be made available to the patients at an affordable cost, it added.
Laxai CEO Dr Ram Upadhaya 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.
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, the release said.
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