An anti-COVID-19 drug, which is developed by the Defence Research and Development Organisation (DRDO), has been approved by the Drugs Controller General of India (DCGI) for emergency use as an adjunct therapy in keeping a note on severe COVID-19 patients.

The approval to the suggested drug has come out at a time when India has been seeing a surve in COVID-19 patients due to the second wave of the coronavirus pandemic that has led the country’s healthcare infrastructure to expand to its possible limit.

Adjunctive therapy is a treatment used together with the primary treatment to assist it. The drug comes in powder form in a sachet and is taken orally by dissolving it in water.

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A potential cancer drug which is repurposed for COVID-19 treatment, 2-Deoxy-D-glucose (2-DG), has received the approval of DCGI for emergency use. The drug was curated by the Nuclear Medicine and Allied Sciences (INMAS), at Defence Research and Development Organisation (DRDO), in collaboration with DR. Reddy’s Laboratories which is a pharmacy major.

The ministry said in a statement that-

“On May 01, DCGI granted permission for emergency use of this drug as adjunct therapy in moderate to severe COVID-19 patients. Being a generic molecule and analogue of glucose, it can be easily produced and made available in plenty in the country.”

Clinical trial results of the drug have shown that it helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence. A higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in COVID-19 patients, a report published by Ministry stated it.

The ministry said the drug will be of high benefit to the people suffering from COVID-19. Talking about the trials the ministry issued few statements with the trials and the phases in which they are planning to carry it all forward.

“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, Hyderabad and found that this molecule works effectively against SARS-CoV-2 virus and inhibits the viral growth”

-the ministry issued this statement for the commencement of trials.

In Phase-II trials which were conducted during May to October 2020, the drug was found to be safe for COVID-19 patients and showed visible improvement in their recovery. Phase II was conducted in six hospitals and Phase IIb (dose ranging) clinical trial was conducted at 11 hospitals all over the country. Phase-II trial was conducted on 110 patients. The ministry said based on successful results, DCGI further permitted the Phase-III clinical trial in November 2020.

In conclusion the Ministry said that-

“The detailed data of Phase-III clinical trial was presented to DCGI. In 2-DG arm, a significantly higher proportion of patients improved symptomatically and became free from supplemental oxygen dependence (42 percent and 31 per cent) by Day-3 in comparison to SoC, indicating an early relief from Oxygen therapy/dependence, this similar trend was observed in patients more than 65 years old.”

 

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