COVID-19: DCGI gives approval for phase-2 clinical trials of Colchicine
India's top drug regulator - the Drugs Controller General of India (DCGI) - has given approval to carry out phase-2 clinical trials of Colchicine on COVID-19 patients. The re-purposed drug, which is already approved for gout and related inflammatory conditions, is expected to reduce cardiac complications in coronavirus patients. The Council of Scientific & Industrial Research (CSIR) made the announcement today.
"The CSIR and Laxai Life Sciences Pvt. Ltd Hyderabad have 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...during the treatment of COVID-19 patients," the CSIR said in a statement.
Colchicine, when administered along with the standard care, can potentially prove beneficial for coronavirus patients with cardiac comorbidities and for reducing pro-inflammatory cytokines, Dr. Shekhar Mande, the Director General of CSIR, said, according to PTI. Several studies have confirmed that many COVID-19 patients develop cardiac issues during the course of the infection, which further increases their risk of death, Dr. Mande added.
According to a study published last year in the medical journal JAMA, a majority of people who had recovered from the coronavirus in the past two to three months suffered abnormalities in the heart. Researchers had also found myocardial inflammation in many of the patients who were tested. Most of these patients had notably not required hospitalization, the study said.
The CSIR-Indian Institute of Chemical Technology (IICT), Hyderabad and CSIR-Indian Institute of Integrative Medicine (IIIM), Jammu will reportedly partner in the trials for Colchicine. The enrollment of patients for these trials has already started and the trials are expected to be completed in the coming 8-10 weeks, according to Ram Upadhayay, the CEO of Laxai Life Sciences.
After facing the world's worst coronavirus outbreak, India's COVID-19 situation is finally improving. In the past 24 hours, the country reported 84,332 fresh coronavirus cases - the lowest daily surge in 70 days. Nearly 25 crore doses of coronavirus vaccines have been administered across India, but only 3.4% of the total population has been fully vaccinated.
