LUCKNOW: The Central Drug Research Institute (CDRI) has claimed to have developed an indigenous anti-viral drug– Umifenovir—for the treatment of Covid-19. Lucknow-based CSIR institution was involved in the clinical trial of this drug.
According to CDRI director Professor Tapas Kundu, the trial of Umifenovir conducted on 132 Covid-19 patients showed that if a proper dose is given twice for five days, it can effectively reduce the viral load in patients with mild or moderate symptoms. Even in asymptomatic patients, it is capable of checking the multiplication of the virus.
The clinical trial of Umifenovir was conducted at King George’s Medical University (KGMU), Ram Manohar Lohia Institute of Medical Sciences (RMLIMS), and Era’s Lucknow Medical College and Hospital (ELMCH).
“Since Umifenovir is a broad-spectrum antiviral which is in use as a safe over-the-counter option for influenza and pneumonia for over 20 years in Russia, China, and other countries, the first two trials were not mandatory,” said the CDRI director.
He added that the CDRI directly went for Phase-III trial which was conducted on 132 patients who were either admitted to hospitals or were under home quarantine under the supervision of these hospitals. The clinical trials also involved patients who were detected with delta variants.
“The results of the clinical study showed that viral load in mild, moderate, or asymptomatic patients after being given two doses of Umifenovir (800mg) twice a day, became zero in an average of five days. Patients did not experience any side effects and their symptoms also did not turn severe,” said the director.
Studies conducted by CDRI in collaboration with CSIR-Institute of Microbial Technology (IMT), Chandigarh, showed that Umifenovir exhibits good cell culture inhibition of SARS-Cov2, suggesting that the drug inhibited the entry of SARS-Cov2 virus into human cells, Prof Kundu said.
He said the institute was getting the dosage plan patented as it had not been used earlier for the treatment of Covid-19. He added that the Drug Controller General of India (DCGI) had evaluated the clinical trials report and with highly encouraging results, he had asked the team to continue the studies on more mild, asymptomatic patients for grant of emergency approval of the drug.
CDRI Chief scientist Prof R Ravishankar, who led the team of scientists, said that Umifenovir would be economical for treating Covid-19 patients as it is around 50-54% cheaper as compared to current medication. The studies showed that the drug was safe for pregnant women and children.
“We are looking into the possibility of Umifenovir syrup for children and also in powder form so that it can be used as puff inhalers,” said Prof Ravishankar.
CDRI spokesperson Sanjeev Yadav said, “Umifenovir was selected from 16 drugs suggested by the CSIR after looking into the feasibility of synthesis using locally available chemicals at the peak of the pandemic. The DCGI then gave permission for trials in June last year.”
A team of CDRI chemists, Ajay K Srivastava, Chandra Bhushan Tripathi, Nayan Ghosh and Nilanjana Majumdar, and their students, synthesized the drug and developed the process technology – chemical processing used to refine raw material into the finished product – in record time.