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HomeHealthCSIR set to seek emergency use approval for sepsis drug Sepsivac repurposed...

CSIR set to seek emergency use approval for sepsis drug Sepsivac repurposed for treating Covid

Licensed for use in sepsis, Sepsivac has shown good results in phase 2 and 3 trials in serious Covid-19 patients. A separate study is also testing the drug as a vaccine.

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New Delhi: The Council of Scientific and Industrial Research (CSIR) is all set to apply for emergency use authorisation for its repurposed Covid-19 drug Sepsivac. The drug, which was originally licensed for use in 2012 in sepsis patients, is being tried as a drug against Covid-19 in moderate and serious patients and has so far given good results.

Speaking to ThePrint, Dr Ram Vishwakarma, honorary advisor to DG-CSIR and former Director, CSIR-IIIM (Indian Institute of Integrative Medicine), said, “The drug was already licensed for use in sepsis … so about a year back, in partnership with the manufacturer Cadila Pharmaceuticals, we started three trials. The first was a phase 2 trial in serious patients, that was completed successfully and went on to a phase 3 trial in 300 patients in PGI Chandigarh, AIIMS Delhi, AIIMS Bhopal and several other sites. That is now about to be completed. We are analysing the data and hope to apply for emergency use authorisation soon.”

He added that the phase 2 trial on moderate patients had also been completed last week. “The third trial is as a prophylactic immunomodator in 4,000 healthcare workers that is ongoing,” he said.

A prophylactic immuno modulator is an agent that prevents infection by activating the immune system of the body.

The idea of the drug, Dr Vishwakarma said, came from the fact that sepsis, which is a state of response of the body to an infection and often affects all organs, is similar to what happens to the body during a cytokine storm.

A cytokine storm caused by a hyperactive immune response is among the most common reasons for death in Covid-19 patients. The phase 3 trial happened in hospitalised patients on oxygen support and gave good results.

According to the US’s national health agency, sepsis is “the body’s extreme response to an infection. It is a life-threatening medical emergency. Sepsis happens when an infection you already have triggers a chain reaction throughout your body. Without timely treatment, sepsis can rapidly lead to tissue damage, organ failure, and death.”


Also read: Why Covid drug Ivermectin remains popular despite warnings & lack of evidence on efficacy


A possible vaccine candidate?

The drug is also being tested as a vaccine in 4,000 healthcare workers in an ongoing phase 2 trial, Dr Vishwakarma said.

“This is what is known as an immunotherapeutic drug/immunomodator that is made from the killed bacteria Mycobacterium w, which, you can say, is a cousin of BCG [vaccine for tuberculosis]. In the body, it triggers the innate or non-specific immunity — that is where the protective or vaccine-like function kicks in. Its second action, when it enters the body, is that it inhibits certain specialised cytokines, like interleukin-6 that can cause problems for Covid patients. It calms the cytokine storm,” Dr Vishwakarma explained.

As a preventive agent, Sepsivac works by activating T-cells, macrophages, natural killer cells and dendritic cells that attack an invading pathogen irrespective of its identity. These cells attack a wide range of disease-causing agents, and most often successfully thwart it even before a pathogen-specific immune response kicks off.

If the trial among healthcare workers is successful, this may be the first vaccine of its kind that does not trigger an immune response specific to the SARS-CoV-2 virus but causes a general activation of the immune system that can help the body fight not just that virus but any virus. Which is why there is also an ongoing discussion about the possibility of teaming it with some existing Covid-19 vaccines to see the results.

(Edited by Manasa Mohan)


Also read: People have to ensure there is no third wave of Covid, says CSIR Director General


 

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