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CSIR To Assess Efficacy Of Gout Drug 'Colchicine' For Covid-19 Treatment, Receives DCGI Approval

CSIR To Assess Efficacy Of Gout Drug 'Colchicine' For Covid-19 Treatment, Receives DCGI Approval
Colchicine is used to prevent or treat the symptoms of gout. (Image: Recovery Trial)

Colchicine is expected to be an important therapeutic intervention for Covid-19 patients with cardiac co-morbidities. But the RECOVERY trial has already closed recruitment to colchicine treatment arm.

Written by Longjam Dineshwori |Published : June 12, 2021 3:56 PM IST

Several reproposed drugs are being used and tested on COVID-19 patients. Colchicine, an anti-inflammatory drug used to treat gout and rheumatic disease, is also seen as a potential treatment for COVID-19. The Council of Scientific and Industrial Research (CSIR) and Hyderabad-based Laxai Life Sciences Pvt Ltd will undertake a two-arm phase-II clinical trial to assess the safety and efficacy of the drug Colchicine for the treatment of Covid-19 patients. They have been given regulatory approval by Drugs Controller General of India (DCGI) for the same.

As indicated by several international studies, cardiac complications during Covid-19 infections and post-Covid syndrome are leading to deaths of many patients. Experts at CSIR believe that Colchicine with standard of care will be an important therapeutic intervention for Covid patients with cardiac co-morbidities and also for reducing pro-inflammatory cytokines, leading to faster recovery. India is one of the largest producers of this drug Colchicine. This means if the drug is found affective in Covid-19 treatment, it would likely be available to Covid patients at an affordable price.

The CSIR-Indian Institute of Chemical Technology (IICT), Hyderabad and CSIR-Indian Institute of Integrative Medicine (IIIM), Jammu will be taking part in this important clinical trial.

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According to Dr Ram Upadhayay, CEO, Laxai, the enrollment of patients for the trial has already begun at multiple sites across India and it is likely to be completed in the next 8-10 weeks.

RECOVERY trial closes recruitment to colchicine arm

Recent clinical studies have found colchicine 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. But, so far, there has been no convincing evidence of its effect on clinical outcomes of COVID-19 patients.

This March, the Randomised Evaluation of COVID-19 Therapy (RECOVERY Trial) in the United Kingdom, the world's largest clinical trial into potential treatments for COVID-19, closed recruitment to the colchicine treatment arm. The RECOVERY trial independent Data Monitoring Committee (DMC) reviewed the available safety and efficacy data on patients randomised to colchicine vs. usual care alone, but found no convincing evidence of worthwhile mortality benefit in patients admitted to hospital with COVID-19.

"On the advice of the DMC, recruitment to the colchicine arm of the RECOVERY trial has now closed. Recruitment to all other treatment arms aspirin, baricitinib, Regeneron's antibody cocktail, and (in selected hospitals) dimethyl fumarate continues as planned," said a statement from the RECOVERY trial chief investigators released on March 5, 2021.

Martin Landray, Professor of Medicine and Epidemiology at the Nuffield Department of Population Health, University of Oxford, and Joint Chief Investigator, noted that the RECOVERY trial has already identified two anti-inflammatory drugs dexamethasone and tocilizumab that improve the chances of survival for patients with severe COVID-19. "So, it is disappointing that colchicine, which is widely used to treat gout and other inflammatory conditions, has no effect in these patients. We do large randomised trials to establish whether a drug that seems promising in theory has real benefits for patients in practice. Unfortunately, colchicine is not one of those," the investigator said.

Peter Horby, Professor of Emerging Infectious Diseases in the Nuffield Department of Medicine, University of Oxford, and Joint Chief Investigator for the RECOVERY trial, added, "This is the largest ever trial of colchicine. Whilst we are disappointed that the overall result is negative, it is still important information for the future care of patients in the UK and worldwide."

The preliminary results of the colchicine comparison were published on MedRxiv on May 18, 2021.