The Central Drug Research Institute (CDRI), Lucknow, a constituent lab of the Council of Scientific and Industrial Research (CSIR), has received permission for carrying out Phase III trials for the use of Umifenovir against coronavirus ( COVID-19 ). The randomised, double-blind, placebo-controlled trial will test the efficacy, safety and tolerability of the drug.
“This drug has a good safety profile and acts by preventing entry of virus into human cells and also by priming the immune system,” a release issued by the Central government on Thursday said.
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Umifenovir, mainly used for the treatment of influenza, is available in China and Russia, and has recently come into prominence due to its potential use for COVID-19 patients.
The Health Ministry added that to evaluate its efficacy in Indian patients, CSIR-CDRI has taken up the clinical trial. The trial will be carried out at King George’s Medical University (KGMU), Dr. Ram Manohar Lohia Institute of Medical Sciences (RMLIMS) and Era’s Lucknow Medical College & Hospital.
“Further it has developed the process technology for Umifenovir in record time and licensed the economical process technology for manufacturing and marketing the drug to M/s. Medizest Pharmaceuticals Private Ltd. Goa, who have already received test license from the Drug Controller General of India (DCGI),” it added.
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Tapas Kundu, Director of CSIR-CDRI, said that all the raw materials for the drug are indigenously available and if the clinical trial is successful, Umifenovir can be a safe, efficacious, affordable drug against COVID-19. Prof. Kundu also added that this drug has the potential for prophylactic use.
Shekhar Mande, Director General of CSIR, said that the clinical trial was an integral part of the CSIR strategy of repurposing drugs for COVID-19.
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The Ministry added that the clinical trial application was processed on high priority in keeping with the DCGI’s initiative against COVID-19. The next steps of the trial are being fast tracked to enable the availability of the drug to patients as soon as possible, it said.
