DRDO's 2-DG anti-Covid drug: All you need to know
TIMESOFINDIA.COM | May 17, 2021, 14:42 IST
TIMESOFINDIA.COM
DCGI approves anti-COVID drug developed by DRDO for emergency use.
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NEW DELHI: Defence Minister Rajnath Singh and Union Health Minister Dr Harsh Vardhan on Monday released the first batch of anti-COVID drug 2-deoxy-D-glucose (2-DG) developed by the Defence Research and Development Organisation (DRDO).
The anti-Covid therapeutic application of the drug has been developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a leading laboratory of the DRDO, in collaboration with Dr Reddy's Laboratories (DRL) in Hyderabad. Earlier this month, the Drugs Controller General of India (DGCI) has approved the oral drug for emergency use as an adjunct therapy in moderate to severe coronavirus patients. The approval of the drug has come at a time when India is grappling with a record-breaking wave of the coronavirus pandemic that has stretched the country's healthcare infrastructure to its limit.
DRDO chairman Dr G Satheesh Reddy said that DRDO and Dr Reddy's lab had gone through the complete trials and conducted trials across 30 hospitals and on a large number of patients.
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 by stopping viral synthesis and energy production. Its selective accumulation in virally infected cells makes this drug unique.
Clinical trial results have shown that this drug helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence. Higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in Covid patients.
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.
PREVENTION
SYMPTOMS
TREATMENT
It said based on these results, the Drugs Controller & Central Drugs Standard Control Organisation (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 clinical trials to test the safety and efficacy of the drug in Covid-19 patients.
In Phase-II trials (including dose ranging) conducted during May-October 2020, the drug was found to be safe in Covid patients and showed significant improvement in their recovery, the ministry statement said adding, Phase-II was conducted in six hospitals and Phase IIb (dose ranging) clinical trial was conducted at 11 hospitals all over the country.
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.
In November 2020, Phase-3 trials were approved and went on from December to April. On May 1, the drug was approved for emergency use. Dr Reddy’s Labs is engaged in its production.
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. The detailed data of phase-III 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.
On May 01, 2021, DCGI granted permission for Emergency Use of this drug as adjunct therapy in moderate to severe Covid-19 patients.
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TIMESOFINDIA.COM | May 17, 2021, 14:42 IST
TIMESOFINDIA.COM
DCGI approves anti-COVID drug developed by DRDO for emergency use.
Get Notifications on latest India News
NEW DELHI: Defence Minister Rajnath Singh and Union Health Minister Dr Harsh Vardhan on Monday released the first batch of anti-COVID drug 2-deoxy-D-glucose (2-DG) developed by the Defence Research and Development Organisation (DRDO).
The anti-Covid therapeutic application of the drug has been developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a leading laboratory of the DRDO, in collaboration with Dr Reddy's Laboratories (DRL) in Hyderabad. Earlier this month, the Drugs Controller General of India (DGCI) has approved the oral drug for emergency use as an adjunct therapy in moderate to severe coronavirus patients. The approval of the drug has come at a time when India is grappling with a record-breaking wave of the coronavirus pandemic that has stretched the country's healthcare infrastructure to its limit.
DRDO chairman Dr G Satheesh Reddy said that DRDO and Dr Reddy's lab had gone through the complete trials and conducted trials across 30 hospitals and on a large number of patients.
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 by stopping viral synthesis and energy production. Its selective accumulation in virally infected cells makes this drug unique.
Clinical trial results have shown that this drug helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence. Higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in Covid patients.
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.
PREVENTION
SYMPTOMS
TREATMENT
It said based on these results, the Drugs Controller & Central Drugs Standard Control Organisation (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 clinical trials to test the safety and efficacy of the drug in Covid-19 patients.
In Phase-II trials (including dose ranging) conducted during May-October 2020, the drug was found to be safe in Covid patients and showed significant improvement in their recovery, the ministry statement said adding, Phase-II was conducted in six hospitals and Phase IIb (dose ranging) clinical trial was conducted at 11 hospitals all over the country.
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.
In November 2020, Phase-3 trials were approved and went on from December to April. On May 1, the drug was approved for emergency use. Dr Reddy’s Labs is engaged in its production.
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. The detailed data of phase-III 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.
On May 01, 2021, DCGI granted permission for Emergency Use of this drug as adjunct therapy in moderate to severe Covid-19 patients.
DRDO's 2-DG anti-Covid drug: All you need to know - Times of India
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