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Indian Researchers Plan Clinical Trials of Sepsis Drug Against New Coronavirus

Indian Researchers Plan Clinical Trials of Sepsis Drug Against New Coronavirus

A view of the CSIR HQ in Delhi. Photo: CSIR/Facebook.

New Delhi: Among other strategies to beat the novel coronavirus, researchers at the Council of Scientific and Industrial Research (CSIR) are also repurposing existing drugs. And one of their latest candidates – Sepsivac, a commercial drug used to treat patients with gram-negative sepsis – seems to offer some promise.

The human body produces defensive agents called cytokines in response to any infection. Cytokines are essential for the host’s defence against pathogens. There are six different types of cytokines, and each type is composed of different families of substances. A specific mix of cytokines is called a cytokine profile, and different cytokine profiles act on different pathogens.

One of the major contributors to death by COVID-19 is a form of heightened immune response called a cytokine storm. In this event, the body develops an aggressive immune response and produces an excess of cytokines, eventually damaging both infected and uninfected cells in the body. The subsequent tissue damage leads to a condition called sepsis.

Gram-negative sepsis occurs when some dangerous gram-negative bacteria release toxins in the blood, in response to which the body produces defensive agents that mitigate the toxin’s effects but also damage the body’s own tissues. Patients affected by gram-negative sepsis also undergo a cytokine storm.

The drug Sepsivac is used to modulate the immune system by reducing the chances of a cytokine storm, in turn reducing mortality and improving the person’s chances of recovery.

Researchers at CSIR had noted similarities between the clinical characteristics of patients suffering from COVID-19 and from gram-negative sepsis, and are now woking on initiating a randomised, blinded, controlled clinical trial to evaluate Sepsivac’s efficacy to reduce mortality in critically ill COVID-19 patients. The Drugs Controller General of India has approved the trial and it is expected to begin soon in multiple hospitals around India.

Sepsivac contains heat-killed bacteria of the species Mycobacterium indicus pranii (previously known as Mycobacterium w or Mw). It is found to be safe in patients and no systemic side effects have been associated with its use. It can also be used concurrently with any other therapies required to manage critically ill patients without any restrictions. Its unique properties include boosting protective immunity and suppressing non-protective response.

Through its flagship New Millennium Indian Technology Leadership Initiative (NMITLI) programme, CSIR has been supporting Cadila Pharmaceuticals Ltd., an Ahmedabad-based company, since 2007 to develop Sepsivac for the treatment of gram-negative sepsis.

“Extensive clinical trials have been conducted by Cadila Pharmaceuticals Ltd on preventing deaths against gram-negative sepsis, with more than 50% reduction in deaths of critically ill patients,” Shekhar C. Mande, the director general of CSIR, said. “We are hoping that the clinical trials will show this to be equally useful in reducing deaths due to COVID-19.”

A CSIR-appointed monitoring committee supervised the entire development effort – including pre-clinical and clinical studies. The drug has already been shown to reduce the mortality of critically ill sepsis patients by more than half, and to  lead to faster recovery of organs rendered dysfunctional by gram-negative sepsis.

Jyoti Singh writes for India Science Wire and tweets at @ashajyoti11.

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