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.

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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