The CSIR — Central Drug Research Institute (CDRI) Lucknow, has received permission for carrying out clinical trial of antiviral drug Umifenovir for treating coronavirus patients.
The Phase III clinical trials 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, Lucknow, it added.
Phase III trials involve testing a drug for safety and efficacy on a large number of humans, usually running into thousands.
“This clinical trial is an integral part of the CSIR strategy of repurposing drugs for covid-19 and complimented the team of scientists of CSIR-CDRI, Nilanjana Majumdar, Ajay Kumar Srivastava, Chandra Bhushan Tripathi and Nayan Ghosh, who were coordinated by Dr. Ravishankar Ramachandran, nodal scientist,” said Dr Shekhar Mande, director-general, CSIR.
“This drug has a good safety profile and acts by preventing the entry of virus into human cells and also by priming the immune system,” said the statement. To be sure, umifenovir does not have the approval of the US drug administration for treatment or prevention of influenza.
Umifenovir is mainly used for treatment of influenza and is available in China and Russia, and has recently come into prominence due to its potential use for COVID-19 patients.
To evaluate its efficacy in Indian patients, CSIR-CDRI has taken up the clinical trial.
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 has already received a test license from DCGI, it added.
CSIR labs have been trying to repurpose different drugs for treating coronavirus patients. For the last three months, the Drug Controller General of India has allowed the use of Favipiravir drug, developed within the country by a CSIR laboratory, for clinical trials to treat coronavirus patients.
In another case, the Council for Scientific and Industrial Research (CSIR), has tied up with Cadila Pharmaceuticals Ltd to evaluate Mycobacterium W (Mw) for faster recovery of hospitalised COVID-19 infected patients.