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DRDO’s anti-COVID drug approved for emergency use

Clinical trial results have shown that this molecule helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence…reports Asian Lite News.

The Drugs Controller General of India has approved an anti-COVID-19 drug developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS) for emergency use, the Defence Ministry has said.

An anti-Covid-19 therapeutic application of the drug 2-deoxy-D-glucose (2-DG) has been developed by INMAS, a lab of the Defence Research and Development Organisation (DRDO), in collaboration with Dr Reddy’s Laboratories (DRL), Hyderabad.

Clinical trial results have shown that this molecule 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 patients. The drug will be of immense benefit to the people suffering from Covid-19.

“Pursuing Prime Minister Narendra Modi’s call for preparedness against the pandemic, DRDO took the initiative of developing anti-COVID therapeutic application of 2-DG,” the ministry said in a statement on Friday.

A health worker inoculates a Man with a dose of the Covishield vaccine against the Covid-19 coronavirus at a school temporary converted into a vaccination center, in New Delhi on India May 03, 2021 (Pallav Paliwal)

In April 2020, during the first wave of the pandemic, INMAS-DRDO scientists conducted laboratory experiments with the help of the Centre for Cellular and Molecular Biology (CCMB), Hyderabad and found that this molecule works effectively against the SARS-CoV-2 virus and inhibits the viral growth.

Based on these results, the Drugs Controller General of India’s (DCGI) Central Drugs Standard Control Organization (CDSCO) permitted the Phase-II clinical trial of 2-DG in COVID-19 patients in May 2020.

The DRDO, along with its industry partner DRL, Hyderabad, started clinical trials to test the safety and efficacy of the drug in COVID-19 patients.

In Phase-II trials (including dose-ranging) conducted from May to October 2020, the drug was found to be safe in Covid-19 patients and showed significant improvement in their recovery.

Phase-IIa was conducted in six hospitals and Phase IIb (dose-ranging) clinical trial was conducted at 11 hospitals all over the country. The Phase-II trial was conducted on 110 patients.

A medical worker prepares a dose of the Covishield vaccine against the Covid-19 coronavirus at a school temporary converted into a vaccination center, in New Delhi on India. (Pallav Paliwal)

Inefficacy trends, the patients treated with 2-DG showed faster symptomatic cure than Standard of Care (SoC) on various endpoints.

“A significantly favorable trend (2.5 days difference) was seen in terms of the median time to achieving normalization of specific vital signs parameters when compared to SoC,” the ministry said.

Based on successful results, the DCGI further permitted the Phase-III clinical trials in November 2020.

The Phase-III 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 the Phase-III clinical trial was presented to the DCGI.

“In 2-DG arm, a 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,” the ministry stated.

A similar trend was observed in patients aged more than 65 years.

On May 1, 2021, the DCGI granted permission for the Emergency Use of this drug as an adjunct therapy in moderate to severe COVID-19 patients.

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DRDO develops oxygen delivery system

Hypoxia is a state in which the amount of oxygen reaching the tissues is inadequate to fulfill all the energy requirements of the body. This is exactly the situation that gets replicated in a Covid patient due to the virus infection and has been a leading factor in the current crisis…reports Asian Lite News.

Defence Research and Development Organisation (DRDO) has developed SpO2 (Blood Oxygen Saturation) supplemental Oxygen Delivery System for soldiers posted at extreme high-altitude areas.

Developed by Defence Bio-Engineering & ElectroMedical Laboratory (DEBEL), Bengaluru of DRDO, the system delivers supplemental oxygen based on the SpO2 levels and prevents the person from sinking in to a state of Hypoxia, which is fatal in most cases, if sets in. This automatic system can also prove to be a boon during the current Covid-19 situation.

Hypoxia is a state in which the amount of oxygen reaching the tissues is inadequate to fulfill all the energy requirements of the body. This is exactly the situation that gets replicated in a Covid patient due to the virus infection and has been a leading factor in the current crisis.

The electronic hardware of the system is designed for functioning at extreme altitudes featuring low barometric pressures, low temperatures and humidity. The software safety checks incorporated into the system are critical in ensuring the functional reliability of the system in field conditions.

DRDO develops SpO2 (Blood Oxygen Saturation) supplemental Oxygen Delivery System which can be used for moderate COVID patients for oxygen flow therapy.https://t.co/qppUAUqfUy pic.twitter.com/8VpbABqZiX
— DRDO (@DRDO_India) April 19, 2021

The system reads SpO2 levels of the subject from a wrist-worn pulse oximeter module through wireless interface and controls a proportional solenoid valve to regulate the oxygen supply to the subject. The oxygen is delivered from a lightweight portable oxygen cylinder through nasal nares.

The system is available in various sizes from one litre and one kg weight with 150 litres of oxygen supply to 10 litres & 10 kg weight with 1,500 litres of oxygen supply which can sustain for 750 minutes with a continuous flow of two liters per min (lpm).

Since the system is indigenously developed for operation in field conditions, it is unique with its dual qualities of being robust & cheap and is already in bulk production with the industry.

The system is a boon in the current pandemic as it can be used in the household for moderate Covid patients for Oxygen flow therapy with flow controlled at 2/5/7/10 lpm flow. The automatic usage has a huge advantage in the household, as the oximeter would give an alarm for lower SpO2 value.

It will automatically increase/decrease the O2 flow based on SpO2 setting which can be auto adjusted at 2, 5, 7, 10 lpm flow rate. The optimal O2 flow rate conserves the O2 resources/O2 management and greatly increases the endurance.

With its availability and simple to use facility by a common person, the system shall greatly reduce the workload and exposure time of doctors and paramedics to monitor the SpO2 levels of the patient. The automated Calibrated Variable Flow Control for Low O2 levels (User preset, <90%, <80%) through a calibrated Flow Control Valve (PFCV) will facilitate in economising the oxygen supply (1-10 lpm with ±0.5 lpm). A moderate Covid patient requires long term moderate O2 supply 10Litre/150bar–10kg–1500 litres which can sustain up to 750 minutes.

This automated, easy to use Oxygen Delivery System now available is a great boon particularly in these critical times when medical resources are stretched to their limits. Its proliferation would mitigate the crisis in management of such a huge number of Covid patients in many ways all across the country.

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