Mumbai-based Bharat Serums and Vaccines Ltd will be conducting clinical trials on the drug ‘ulinastatin’ for the treatment of COVID-19 patients suffering from acute respiratory distress syndrome, PTI reported.
Ulinastatin is an approved drug currently used for severe sepsis and acute pancreatitis.
The company announced that it has received approval from the drug regulator of India. The trials will be conducted in 6-8 hospitals and will cover 120 patients. With this, BSVL will be joining other pharmaceutical firms who are studying drugs for the treatment of the novel coronavirus.
The drug could possibly help treat the inflammatory response caused by the cytokine storm in the bodies of COVID-19 patients experiencing mild-to-moderate ARDS, BSVL said.
"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," it added.
Importantly, there is no approved treatment for the disease yet. Patients are symptomatically treated with supportive therapy. Repurposing of existing drugs, such as ulinastatin, has been one of the ways researchers aim to fast-track a possible course of treatment.
Parallels Between Gram-Negative Sepsis & COVID-19
In April, the health ministry had shared that the Council of Scientific and Industrial Research (CSIR) was starting a randomized clinical trial to evaluate the drug ‘Sepsivac’, initially developed for treating patients suffering from gram-negative sepsis.”
FIT had spoken to doctors who explained the clinical similarities between the illnesses.
Dr Prakash Doraiswamy, Senior Consultant, Critical Care and Anaesthesiology at Aster CMI Hospital, said,
Now how exactly does this work?
Dr Shahid Jameel, a well-known Virologist and CEO of Wellcome Trust DBT India Alliance, explained, “In sepsis, the body overreacts to an infection. In a normal immune response, certain molecules called cytokines are produced in the body. When the infection is overwhelming, the body increases its cytokine output and there is an overreaction of the immune system, which eventually starts attacking healthy tissues as well. This can lead to a condition known as ‘cytokine storm’, because of which many organs start shutting down. This multiple organ failure is one of the hallmarks of sepsis.”
In many people who are dying of COVID-19, a similar effect on multiple organs of the body is being observed, he adds. While the lung is deeply damaged, the virus and the body’s response to it could injure many other organs. “The infection seeps into all organs and has been seen to cause damage to the lungs, heart, kidneys, liver, blood vessels.”
(With inputs from PTI)
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