From Our Special Correspondent
Daijiworld Media Network
Bengaluru, May 14: Close on the heels of the news about India’s premier science institute, the Indian Institute of Science (IISc), Bengaluru developing a very efficient vaccine against the Covid pandemic, comes news from another central facility Defence Research Development Organisation (DRDO) campus in Bengaluru developing a 2-DG drug that promises to help in the faster recovery of hospitalized Covid patients and reduces their oxygen dependence.
Karnataka’s health and family welfare as well as medical education minister Dr K Sudhakar, who visited the IISc, Bengaluru and interacted with its director Prof Govindan Rangarajan on Thursday, paid a visit to the DRDO campus in the city and interacted with its scientists on Friday to learn about the development of the 2-DG drug, which he said could be a game-changer in the battle against the pandemic.
"The 2-DG drug developed by DRDO is a big breakthrough and could be a game-changer in the battle against pandemic as it helps in faster recovery of hospitalised patients and reduces oxygen dependence,’’ Dr Sudhakar said.
PM-CARES Fund will procure 1.5 lac units of Oxycare System at a cost of Rs 322.5 crore, he said.
Dr Sudhakar said another innovative solution, the Oxycare System, reduces the workload and exposure of healthcare providers by eliminating the need of routine measurement and manual adjustments of oxygen flow.
2-DG drug, a game-changer
An anti-COVID-19 therapeutic application of the drug 2-deoxy-D-glucose (2-DG) has been developed by Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of 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, the DRDO scientists told the minister.
Pursuing Prime Minister Narendra Modi’s call for preparedness against the pandemic, DRDO took the initiative of developing an anti-Covid therapeutic application of 2-DG.
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.
Clinical trials, approvals
Based on these results, the Drugs Controller General of India’s (DCGI) Central Drugs Standard Control Organization (CDSCO) permitted a 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 trial 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.
In the 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.
Based on successful results, 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, Dr Sudhakar said quoting information from DRDO scientists.
The detailed data of the phase-III clinical trial was presented to DCGI. In the 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. A similar trend was observed in patients aged more than 65 years.
On May 1, 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 and analogue of glucose, it can be easily produced and made available in plenty in the country,’’ DRDO scientists said.
The drug comes in powder form in sachets, which is taken orally by dissolving it in water. It accumulates in the virus-infected cells and prevents virus growth by stopping viral synthesis and energy production. Its selective accumulation in virally infected cells makes this drug unique.
In the ongoing second Covid-19 wave, a large number of patients are facing severe oxygen dependency and need hospitalization, the minister mentioned.
The drug is expected to save precious lives due to the mechanism of operation of the drug in infected cells. This also reduces the hospital stay of Covid-19 patients.
Oxycare System, a smart solution
Oxycare System is a comprehensive system developed by DRDO to regulate oxygen being administrated to patients based on the sensed values of their SpO2 levels. The system has been developed in two configurations.
The basic version consists of a 10-litre oxygen cylinder, a pressure regulator cum flow controller, a humidifier and a nasal cannula.
The oxygen flow is regulated manually based on the SpO2 readings. The intelligent configuration includes a system for automatic regulation of oxygen through a low pressure regulator, electronic control system and a SpO2 probe in addition to the basic version.
SpO2-based oxygen control system optimises the consumption of oxygen based on the SpO2 level of the patient and effectively increases the endurance of the portable oxygen cylinder.
The threshold SpO2 value for initiating flow from the system can be adjusted by the health staff and the SpO2 levels are continuously monitored and displayed by the system.
It reduces the workload and exposure of healthcare providers by eliminating the need for routine measurement and manual adjustments of Oxygen flow, thereby facilitating teleconsultation also.
The automatic system also provides a suitable audio warning for various failure scenarios including low SpO2 values and probe disconnections.
These Oxycare Systems can be used at homes, quarantine centres, Covid Care Centres and hospitals, according to DRDO scientists.
In addition, Non-Rebreather Masks (NRM) are integrated with the Oxycare Systems for efficient use of oxygen which results in saving oxygen by 30-40%.
DRDO has transferred the technology to multiple industries in India that will be producing the Oxycare Systems for use all across India.
The current medical protocol recommends oxygen therapy for all severe and critical Covid-19 patients. Given the current status of oxygen generation, transport and storage, oxygen cylinders have proved to be effective.
Considering the present Covid pandemic situation with a large number of individuals requiring oxygen therapy, sourcing only one type of system may not be practical, as all the manufacturing plants making the basic building blocks of the system are already running at their maximum capacity, the minister felt.
A mix and match of the system would prove to be a useful arrangement in the given situation.
While the capacity of existing domestic manufacturers of carbon-manganese steel cylinders is very limited, as an alternative, DRDO has suggested light material portable cylinders which can easily act as substitutes for normal oxygen cylinders.
Minister lauds IISc, DRDO scientists
PM-CARES Fund has accorded sanction for procurement of 1,50,000 units of Oxycare System at a cost of Rs 322.5 crore.
"Bengaluru is the science and technology capital of India and home to several premier institutes. The efforts of institutes like IISc and DRDO to find innovative and effective solutions to fight this pandemic is laudable. The vaccine developed by IISc which can be stored in warm temperatures and the 2-DG drug and Oxycare System developed by DRDO are game-changers in the battle against Covid-19," said Dr Sudhakar.