India to go for clinical trial of sepsis drug to fight Covid-19

India's state-owned Council of Scientific and Industrial Research (CSIR) is initiating a clinical trial to evaluate the efficacy of a drug, which is meant for saving lives of critically ill patients suffering from Gram-negative sepsis, to reduce the deaths of critically ill Covid-19 patients.

Gram-negative bacteria cause infections including pneumonia, bloodstream infections, wound or surgical site infections, and meningitis in healthcare settings.

The CSIR, through its flagship New Millennium Indian Technology Leadership Initiative (NMITLI) programme, has been supporting Cadila Pharmaceuticals Ltd, Ahmedabad since 2007 for developing a drug to save lives of critically ill patients suffering from Gram-negative sepsis, our New Delhi correspondent reports quoting an official statement issued last night.

The entire development effort (pre-clinical and clinical studies) has been supervised by a CSIR-appointed monitoring committee.

The drug has been shown to reduce the mortality of critically ill patients by more than half. It also leads to faster recovery of organ dysfunction seen in this condition, an official statement said last night. It is now approved for marketing in India and will be available commercially. No other drug was approved in Gram-negative sepsis for reducing mortality (death) globally, the statement said.

In Gram-negative sepsis as well as in critically ill Covid-19 patients, there is an altered immune response leading to a massive change in their cytokine profile. The drug modulates the immune system of the body and thereby inhibits the cytokine storm leading to reduced mortality and faster recovery.

"Looking at similarities between clinical characteristics of patients suffering from Covid-19 and Gram-negative sepsis, the CSIR is now initiating a randomised, blinded, two arms, active comparator-controlled clinical trial to evaluate the efficacy of the drug for reducing deaths in critically ill Covid-19 patients," according to the statement.

The Drugs Controller General of India (DCGI) has approved the trial and it will start soon at multiple hospitals, it said.