Bharat Serums gets DCGI nod to test sepsis drug on Covid-19 patients
Bharat Serums and Vaccines Ltd (BSVL) has received approval from the Drug Controller General of India (DCGI) to conduct phase-III clinical study on ulinastatin for mild-to-moderate acute respiratory distress syndrome (ARDS) patients with COVID 19, the company said in a statement.
New Delhi: Bharat Serums and Vaccines Ltd on Monday said it has received approval from the country's drug regulator to conduct clinical trials on existing drug ulinastatin for the potential treatment of patients with COVID-19 who are suffering from acute respiratory distress syndrome.
The company will join leading pharma firms Sun Pharmaceutical Industries, Glenmark Pharmaceuticals, and Strides Pharma Science that have already started clinical trials for potential drugs for COVID-19.
Bharat Serums and Vaccines Ltd (BSVL) has received approval from the Drug Controller General of India (DCGI) to conduct phase-III clinical study on ulinastatin for mild-to-moderate acute respiratory distress syndrome (ARDS) patients with COVID 19, the company said in a statement.
Ulinastatin is currently approved in India for severe sepsis and acute pancreatitis, it added.
"The clinical trials will be conducted in COVID-19 patients who are serious and are being hospitalised because of ARDS. Identifying effective antiviral agents and therapies to combat underlying pathology of COVID-19 is the need of the hour,"Â BSVL MD and CEO Sanjiv Navangul told PTI.
The trials would be conducted in 6-8 hospitals, he added.
Patients with severe coronavirus infection can develop fatal lung damage from a cytokine storm due to an increase in pro-inflammatory cytokines. Ulinastatin could combat underlying inflammatory condition in COVID-19 patients experiencing mild-to-moderate ARDS, BSVL said.
While there is no approved treatment against the SARS-CoV2 virus yet and experimental drugs are currently being used as a supportive therapy, it added.
"As per the approved clinical trial protocol, subjects with mild-to-moderate ARDS due to COVID-19 will be randomised in the study in a 1:1 ratio with ulinastatin and standard supportive care or standalone standard supportive care," BSVL said.
The product is being manufactured at the company's Ambernath facility at Thane in Maharashtra, it added.
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