Lucknow: Central Drug Research Institute (CDRI) claimed on Tuesday that clinical trials of antiviral drug, umifenovir, have been successful in the treatment of Kovid-19.
Trial of umifenovir on 132 COVID-19 patients has shown that, if the appropriate dosage is given twice daily for five days, the drug can effectively reduce the viral load in mild or moderately symptomatic and asymptomatic patients by checking the multiplication of the virus. can reduce.
Clinical trial in three institutions, titled ‘Phase III, randomized, double-blind, placebo-controlled trial of efficacy, safety and tolerability of antiviral drug Umifenovir versus standard of therapy in non-severe COVID-19 patients’ It was organized by – King George’s Medical University (KGMU), Ram Manohar Lohia Institute of Medical Sciences (RMLIMS) and Lucknow Medical College and Hospital (ELMCH) of Era.
“Since Umifenovir is a broad-spectrum antiviral and has been used in Russia, China and other countries as a safe over-the-counter drug for influenza and pneumonia for more than 20 years, the first two trials were not mandatory. Hence, CDRI went straight for Phase-III trial, which was conducted on 132 patients who were either admitted in hospitals or were under home quarantine under the supervision of these hospitals,” CDRI Director Prof. Tapas Kundu said.
“In one study, when doctors evaluate patients’ outcomes, the double-blind mode improves the reliability of results by preventing bias. Results showed that Umifenovir twice a day in patients with mild, moderate, or no symptoms After two doses of (800mg), the viral load dropped to zero in an average of five days. Patients experienced no side effects and did not have severe symptoms.”
“Studies conducted by CDRI in association with CSIR-IMT, Chandigarh also showed that Umifenovir exhibits good cell culture inhibition of SARS-Cov2, which suggests that the drug inhibits the entry of SARS-Cov2 virus into human cells. stops.” pro kundu said.
He said that the institute is patenting the dosage scheme as it was not used earlier for Kovid-19.
“The Drug Controller General of India (DCGI) has evaluated the clinical trial reports and given the highly encouraging results, they have asked the team to continue the study on more mild, asymptomatic patients for emergency approval of the drug,” he said. added.
Chief Scientist, CDRI, Professor R Ravi Shankar, who led the team of scientists, said: “Umifenovir will be economical to treat Covid-19 patients as it is about 50-54% cheaper than the current drug. Experts from three hospitals involved in the study said that the drug is safe for pregnant women and children. We are looking at the possibility of umifenovir syrup for children and also in powder form to be used as a puff inhaler.
According to CDRI, the head of the Department of Medicine of KGMU, Dr. Virendra Atmi, and medical superintendent, Dr Himanshu Reddy, who was the principal investigator of the study at the university, noted in his report for the study that faster recovery of coronavirus patients would reduce the shedding of the virus and consequently spread the infection to others. .
Also said that the Principal of Medical College of Era, Pro MMA Faridik, has mentioned in its report that Umifenovir can be prescribed for pregnant women and children if approved by the authorities.
Similarly, Prof Vikram Singh of RMLIMS suggested that since Umifenovir was safe, it had a significant effect on mild and asymptomatic patients and may also be useful as a prophylactic for high-risk patients.
CDRI Spokesperson Sanjeev Yadav “Umifenovir was selected out of 16 drugs recommended by CSIR after looking at the feasibility of synthesis using locally available chemicals at the peak of the pandemic. After this, DCGI had given permission for the trial in June last year.
A team of CDRI chemists, Ajay K Srivastava, Chandra Bhushan Tripathi, Nayan Ghosh and nilanjana majumdar, and his students synthesized the drug and developed the process technology — chemical processing to refine raw materials into a finished product — in record time.
Within a month the technology was transferred to a Goa-based private pharmaceutical company to make “active pharmaceutical ingredients” (APIs) and tablets for testing.
Finally, after obtaining ethical approval and completing a drug stability study at CDRI, the team of researchers obtained the consent of the patients and included them for the study.
Trial of umifenovir on 132 COVID-19 patients has shown that, if the appropriate dosage is given twice daily for five days, the drug can effectively reduce the viral load in mild or moderately symptomatic and asymptomatic patients by checking the multiplication of the virus. can reduce.
Clinical trial in three institutions, titled ‘Phase III, randomized, double-blind, placebo-controlled trial of efficacy, safety and tolerability of antiviral drug Umifenovir versus standard of therapy in non-severe COVID-19 patients’ It was organized by – King George’s Medical University (KGMU), Ram Manohar Lohia Institute of Medical Sciences (RMLIMS) and Lucknow Medical College and Hospital (ELMCH) of Era.
“Since Umifenovir is a broad-spectrum antiviral and has been used in Russia, China and other countries as a safe over-the-counter drug for influenza and pneumonia for more than 20 years, the first two trials were not mandatory. Hence, CDRI went straight for Phase-III trial, which was conducted on 132 patients who were either admitted in hospitals or were under home quarantine under the supervision of these hospitals,” CDRI Director Prof. Tapas Kundu said.
“In one study, when doctors evaluate patients’ outcomes, the double-blind mode improves the reliability of results by preventing bias. Results showed that Umifenovir twice a day in patients with mild, moderate, or no symptoms After two doses of (800mg), the viral load dropped to zero in an average of five days. Patients experienced no side effects and did not have severe symptoms.”
“Studies conducted by CDRI in association with CSIR-IMT, Chandigarh also showed that Umifenovir exhibits good cell culture inhibition of SARS-Cov2, which suggests that the drug inhibits the entry of SARS-Cov2 virus into human cells. stops.” pro kundu said.
He said that the institute is patenting the dosage scheme as it was not used earlier for Kovid-19.
“The Drug Controller General of India (DCGI) has evaluated the clinical trial reports and given the highly encouraging results, they have asked the team to continue the study on more mild, asymptomatic patients for emergency approval of the drug,” he said. added.
Chief Scientist, CDRI, Professor R Ravi Shankar, who led the team of scientists, said: “Umifenovir will be economical to treat Covid-19 patients as it is about 50-54% cheaper than the current drug. Experts from three hospitals involved in the study said that the drug is safe for pregnant women and children. We are looking at the possibility of umifenovir syrup for children and also in powder form to be used as a puff inhaler.
According to CDRI, the head of the Department of Medicine of KGMU, Dr. Virendra Atmi, and medical superintendent, Dr Himanshu Reddy, who was the principal investigator of the study at the university, noted in his report for the study that faster recovery of coronavirus patients would reduce the shedding of the virus and consequently spread the infection to others. .
Also said that the Principal of Medical College of Era, Pro MMA Faridik, has mentioned in its report that Umifenovir can be prescribed for pregnant women and children if approved by the authorities.
Similarly, Prof Vikram Singh of RMLIMS suggested that since Umifenovir was safe, it had a significant effect on mild and asymptomatic patients and may also be useful as a prophylactic for high-risk patients.
CDRI Spokesperson Sanjeev Yadav “Umifenovir was selected out of 16 drugs recommended by CSIR after looking at the feasibility of synthesis using locally available chemicals at the peak of the pandemic. After this, DCGI had given permission for the trial in June last year.
A team of CDRI chemists, Ajay K Srivastava, Chandra Bhushan Tripathi, Nayan Ghosh and nilanjana majumdar, and his students synthesized the drug and developed the process technology — chemical processing to refine raw materials into a finished product — in record time.
Within a month the technology was transferred to a Goa-based private pharmaceutical company to make “active pharmaceutical ingredients” (APIs) and tablets for testing.
Finally, after obtaining ethical approval and completing a drug stability study at CDRI, the team of researchers obtained the consent of the patients and included them for the study.
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