clinical trial of sepsis drug

Clinical Trial of Sepsis Drug Against Covid-19 By Indian Researchers

One of the strategies deployed by the Council of Scientific and Industrial Research (CSIR) is the repurposing of existing drugs. This strategy is being implemented by the Council by evaluating an existing drug that is used for treating gram-negative sepsis patients.

The Sepsivac drug is commercially available. The altered immune response leads to a massive change in the cytokine profile in critically ill COVID-19 patients and in Gram-negative sepsis patients. As a response to an infection, cytokines are produced. For host defense against pathogens, cytokines are essential. Cytokines are of 6 types and there are different families of cytokines in each type. Different pathogens are acted upon by different mix of cytokines known as cytokine profiles. An immune response called a cytokine storm is one of the major contributors to death by COVID-19.

Both the infected and uninfected cells start getting attacked by the immune system. This leads to tissue damage, in turn, resulting in sepsis as it does not make any difference between a friend and a foe. The drug leads to reduced mortality and faster recovery as it modulates the immune system of the body and thereby inhibits

the cytokine storm.

Cytokine storm is also experienced by Gram-negative sepsis patients. Thus, to evaluate the efficacy of the drug for reducing mortality (deaths) in critically ill COVID-19 patients, CSIR is now initiating a randomized, blinded, two arms, active comparator-controlled clinical trial after looking at the similarities between clinical characteristics of patients suffering from COVID-19 and Gram-negative sepsis. The trial will start soon at multiple hospitals as it was approved by the Drugs Controller General of India (DCGI).

Heat-killed Mycobacterium W (Mw) is present in the drug. No systemic side effects are associated with its use and it is found to be safe in patients. Without any restriction, it can be used simultaneously with any other therapies required. Suppressing non-protective response (Th2) and boosting protective immunity (Th1, TLR2 agonist) are among its unique properties.

The Director-General of CSIR, Dr. Shekhar C Mande said, ” On preventing deaths against gram-negative Sepsis, with more than 50% reduction in deaths of critically ill patients, extensive clinical trials have been conducted by Cadila Pharmaceuticals Ltd. In reducing deaths due to Covid-19, we hope that the clinical trials will show this to be equally useful.”

Since 2007, for developing this drug to save the lives of critically ill patients suffering from Gram-negative sepsis, Cadila Pharmaceuticals Ltd., Ahmedabad has been receiving support from CSIR through its flagship New Millennium Indian Technology Leadership Initiative (NMITLI) program. CSIR appointed Monitoring Committee has supervised this entire development effort (pre-clinical and clinical studies). The mortality of critically ill patients reduced by more than half with the use of this drug. Organ dysfunction seen in this condition was also led to faster recovery by the drug. In India, it is approved now for marketing.