WHAT HAS HAPPENED?
The Drugs Controller General of India (DCG) has approved the emergency use of Drug 2-deoxy-D-glucose (2-DG) as an adjunet therapy in moderate to severe Covid-19 patients.
WHO DEVELOPED IT?
The Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of Defence Research and Development Organisation (DRD0), has developed the drug, In collaboration with Dr Reddy's Laboratories, Hyderabad.
WHEN & HOW IT WAS DEVELOPED?
In April 2020, during the first wave of the pandemic, INMAS-DRDO scientists conducted laboratory experiments with the help of Centre for Cellular and Molecular Biology (CCMB), Hyderabad and Found that this molecule works effectively against SARS-CoV-2 virus and inhibits the viral growth. Based on these results, Drugs Controller General of India's (DCG) Central Drugs Standard Control Organization (CDSCO) permitted Phase-II clinical trial of 2-DG in COVID-19 patients in May 2020.
The DRDO, along with its industry partner DRL, Hyderabad, started the elinical trials to test the safety and efficacy of the drug in COVID-19 patients. In Phase-II trials conducted during May to October 2020, the drug was found to be safe in COVID-19 patients and showed significant
improvement in their recovery.
Phase Ila was conducted in six hospitals and Phase IIb clinical trial was conducted at 11 hospitals all over the country. Phase-II trial was conducted on 110 patients.
In efficacy trends,the patients treated with 2-DG showed faster symptomatic cure than Standard of Care (SoC) on various endpoints. A significantly favourable trend (2.5 days difference) was seen in terms of the median time to achieving normalisation of specific vital signs parameters when compared to SOC.
PHASE 3
Based on successful results, DCGIl further permitted the Phase-1II clinical trials in November 2020. The Phase-IIl clinical trial was conducted on 220 patients between December 2020 to March 2021 at 27 COVID hospitals in Delhi, Uttar Pradesh, West Bengal, Gujarat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu. The detailed data of phase-IlI clinical trial was presented to DCGI.In 2-DG arm, significantly higher proportion of patients improved symptomatically and became free from supplemental oxygen dependence(42% vs 31%) by Day-3, In comparison to SoC, indicating an early relief from Oxygen therapy/dependence.
PATIENTS ABOVE 65 YEARS
The similar trend was observed in patients aged more than 65 years.On May 01, 2021, DCGI granted permission for Emergency Use of this drug as adjunct therapy in moderate to severe COVID-19 patients.
2-DG, works by preventing the supply of glucose molecules to the cancerous cells, which need glucose for survival. With the drug stopping the glucose supply, the cells start dying.The drug is, however, not yet approved for cancer treatment.
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