New Delhi, Jun12: The Council of Scientific and Industrial Research (CSIR) in collaboration with Hyderabad based pharma company Laxai Life Sciences Pvt Ltd has been given the regulatory approval by DCGI 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.
The CSIR allied institute -Indian Institute of Chemical Technology (IICT), Hyderabad and CSIR-Indian Institute of Integrative Medicine (IIIM), Jammu have also been roped in this clinical trial process.
This drug once go through the second trial phase, will l be an important therapeutic intervention for Covid patients with cardiac co-morbidities and also for reducing proinflammatory cytokines, leading to faster recovery with special care provided to them.
Laxai CEO Dr Ram Upadhayay has 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.
Expressing satisfaction over the regulatory approval, the CSIR Director General Dr Shekhar C Mande said that Colchicine will be used for treating gout and related inflammatory conditions while the advisor to the CSIR Dr Ram Vishwakarma said that 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.
Both directors of the partner institutes CSIR-IICT Hyderabad and CSIR-IIIM, Jammu) also 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.
“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”, they added.
