Covid-19: AstraZeneca to bring Dare-19 trial to India; 10 sites identified

Biopharmaceutical major AstraZeneca, which has undertaken a global research study to test the effects of drug dapagliflozin in preventing serious complications such as organ failure in Covid-19 patients, is likely to begin the trials in India by July end.

Called the Dare 19 trial, it is one of the several global research efforts by the British company to find a solution to treat Covid-19. Ten sites have already been identified for the study in India and the process is on to get approval from the Drugs Controller General of India for this.

“We hope to start the process by the end of July and timelines are very tight so we expect to finish the trials in September and have the results shortly thereafter,” said V K Chopra, senior director at Max hospital, who been appointed the national coordinating investigator for Dare 19 study in India by Saint Luke’s mid America heart institute. The institute has collaborated with AstraZeneca to initiate a global Phase III trial to assess the potential of Forxiga (dapagliflozin) as a treatment in patients hospitalised with Covid-19 who are at risk of developing serious complications.

Forxiga, which is an anti-diabetic drug, has also been approved in India for treatment of patients with heart failures.

“Heart failure is a serious health condition that affects 6.4 crore people worldwide and at least 8–10 million in India. The accelerated regulatory approval in India will provide the much-needed treatment to help patients reduce their disease burden and live longer,” said Gagandeep Singh, Managing Director, AstraZeneca India. The drug has been priced at Rs 57 per day for India.

AstraZeneca is also in partnership with Pune-headquartered vaccine maker Serum Institute of India to provide one billion doses of University of Oxford's potential Covid-19 vaccines to low and middle-income countries, with a commitment to provide 400 million before the end of 2020.