CSIR-Laxai get DCGI nod to begin Colchicine trials on Covid patients
By TIOL News Service
NEW DELHI, JUN 12, 2021: THE Council of Scientific and Industrial Research (CSIR) and Laxai Life Sciences have received approval from the Drug Controller General of India (DCGI) to undertake a two-arm phase-2 clinical trial to assess the safety and efficacy of the drug Colchicine in improvement of clinical outcomes during the treatment of COVID-19 patients.
Colchicine is a drug used for treating gout and related inflammatory conditions. In combination with standard care, it will be an important therapeutic intervention for Covid patients with cardiac comorbidities and also for reducing pro-inflammatory cytokines, leading to faster recovery.
A number of global studies have confirmed that cardiac complications during the course of COVID-19 infection and post-Covid syndrome are leading to loss of many lives, and it is essential to look for new or repurposed drugs.
The partner CSIR institutes in this important clinical trial are the CSIR-Indian Institute of Chemical Technology (IICT) in Hyderabad and the CSIR-Indian Institute of Integrative Medicine (IIIM) in Jammu.
The enrolment of patients has already begun at multiple sites across the country and the trial is likely to be completed in the next 8-10 weeks.
The phase-2 clinical efficacy trial of Colchicine may lead to life-saving interventions in the management of hospitalised patients. The drug can be made available to large population based on the results of the trial and regulatory approval.
"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 statement from the Ministry of Science and Technology.
Recent clinical studies in leading medical journals have found 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.