Can a drug used to treat severe sepsis be deployed for critically ill coronavirus ( COVID-19 ) patients?
Sepsivac, a drug jointly developed by the Ahmedabad-based Cadilla Pharmaceuticals and the Council for Scientific and Industrial Research (CSIR), will be tested in 50 COVID-19 patients at the All-India Institute of Medical Sciences in Delhi and Bhopal, and Post Graduate Institute of Medical Education and Research, Chandigarh.
Results from a human trial are expected in the next two months, Ram Vishwakarma, Director, Indian Institute of Integrative Medicine, Jammu, told The Hindu . IIIM is a CSIR laboratory and was involved in the early development of Sepsivac.
Sepsivac was originally developed for treating sepsis by a class of pathogens called gram negative bacteria, that are known to cause life-threatening infections. Given the similarities in the immune-system response in critically ill COVID-19 patients, it is theorised, the therapy could stimulate a benign response.
A large quantity of cytokines, chemicals signalling the presence of an infection, are produced in the early stages of the body’s response against an infection to stimulate the production of antibodies. However, cytokines also cause inflammation of organs and can be counter-productive in protecting the body. Keeping them in check is the goal of so called immuno-modulators, or medicines like Sepsivac.
“The advantage is that we have a ready made product and can be put into trials. We already have an approval for phase-3 [large trials] and can be scaled up if it shows promise,” Dr. Vishwakarma added.
The drug uses the Mycobacterium w (formally known as mycobacterium indicus pranii) as it produces a different immune-system response.
Previous randomised trials in sepsis patients showed 11% absolute reduction and 55.5% relative reduction in mortality. Sepsivac reduces the days on ventilator, in ICU and hospital and incidence of secondary infection, Cadilla Pharmaceuticals have claimed on their website.
The United States and Australia are also going to start testing the efficacy of the BCG , or tuberculosis vaccine, that also employs a different strain of mycobacterium, in health care workers at the frontline of treating COVID-19 patients.
Statistics suggest that of India’s nearly 19,000 COVID-19 cases as on Tuesday, 3,800 had a clinical outcome — that is, they had either recovered/been discharged or had died. The death rate in those with an outcome was 16%.
CSIR has also planned to evaluate Mw for faster recovery of hospitalised COVID-19 infected patients and minimise the spread of disease through them as well for providing preventive treatment (prophylaxis) to persons coming in contact with COVID-19 infected patients like family members and health care workers, it said in a statement.