Several researchers and institutes in India are working tirelessly to find a viable solution against the COVID-19 virus. Institute of Nuclear Medicine and Allied Sciences (INMAS) has developed an anti-COVID drug (2-deoxy-D-glucose). The drug has been approved by the Drugs Controller General of India (DGCI) for emergency use.
INMAS, a lab of Defence Research and Development Organisation, in collaboration with Dr. Reddy’s Laboratories (DRL), Hyderabad has developed an anti-COVID-19 therapeutic application of the drug, 2-deoxy-D-glucose (2-DG). Therapeutics is the branch of medicine that is concerned specifically with the treatment of disease.
The drug comes in powder form in a sachet, which is taken orally by dissolving it in water. It accumulates in the virus-infected cells and prevents virus growth.
A higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in COVID patients. The drug can help the infected patients to fight against the virus.
In April 2020, INMAS-DRDO scientists conducted laboratory experiments with the help of the Centre for Cellular and Molecular Biology (CCMB), Hyderabad, and found that the drug works effectively against the SARS-CoV-2 virus and restrain viral growth.
Based on these results, DCGI’s Central Drugs Standard Control Organization (CDSCO) permitted Phase-II clinical trial of 2-DG in May 2020. DRDO with its industry partner DRL, Hyderabad, started the clinical trial on COVID-19 patients to measure the safety and efficacy of the drug. The Phase II trial was between May to October 2020, where the drug was tested on patients which incused the dose-ranging of the drug.
The drug was tested on 110 patients in Phase II. Further, In Phase II (a) it was tested in six hospitals, whereas Phase II (b) was conducted in 11 hospitals. The drug was found to be effective against the virus as the patient’s health was improved significantly. In efficacy trends, the patients treated with 2-DG showed faster symptomatic cure than Standard of Care (SoC) on various points.
Based on successful results, DCGI permitted the drug for the Phase-III clinical trials in November 2020. The drug was tested on 220 patients between Dec 2020 to Mar 2021. It was tested in 27 COVID hospitals across 9 States and New Delhi.
The detailed data from the Phase III trials was presented to DCGI. A significant number of patients administered with the drug became free from supplemental oxygen dependence (42% vs 31%) by Day-3 in comparison to Standard of Care (SoC).
A similar trend was observed in patients aged more than 65 years. On May 01, 2021, DCGI granted permission for the emergency use of this drug as an adjunct therapy in moderate to severe COVID-19 patients. Being a generic molecule, the drug can be easily produced and in a short period, it can be distributed across the country.