The Drugs Controller General of India has approved the trial of a drug developed for the treatment of critically-ill gram-negative sepsis patients, to evaluate if it can reduce mortality (deaths) in critically-ill COVID-19 patients.

Sepsivac has been developed by Ahmedabad-based Cadila Pharmaceuticals and supported by the Council of Scientific and Industrial Research (CSIR), for gram-negative sepsis patients. Due to the similarities between the clinical characteristics of COVID-19 and gram-negative sepsis patients, CSIR will initiate trials “soon” to test its efficacy, an April 20 government statement said.

Gram-negative sepsis and COVID-19

In response to an infection, cells in the human body produce small proteins called cytokines. There are both pro-inflammatory and anti-inflammatory cytokines.

These two types of cytokines constitute a “double-edged sword” in sepsis, a life-threatening condition in which chemicals released by the body to fight an infection trigger inflammation all over the body, a 2013 study noted. On the one hand, cytokines are critical to eliminate the infection, while on the other, excessive production can cause tissue and organ damage.

Based on a study in Wuhan, the epicentre of the COVID-19 in China, and after examining the clinical features and cytokine profile of critically-ill COVID-19 patients, a cytokine storm is understood to be associated with the severity of disease.

Cytokine storms occur when excessive or uncontrolled levels of cytokines are released, activating more immune cells, resulting in hyperinflammation, and causing sepsis or organ failure--which can all be fatal.

Gram-negative sepsis patients also face cytokine storms when gram-negative bacteria produce toxins for which the body produces combating agents, causing “diverse effects on host tissues, including organ dysfunction and shock”.

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”, noted the government release.

Sepsivac contains heat-killed Mycobacterium W (Mw) that is found to be “extremely safe in patients and no systemic side effects are associated with its use”. The drug modulates the immune system of the body and thereby inhibits the cytokine storm leading to reduced mortality and faster recovery.

(Paliath is an analyst with IndiaSpend.)