May 3, 2020
CSIR is currently testing Cadila Pharmaceuticals’ “Sepsivac” against COVID-19. This treatment was developed as a result of a partnership between CSIR and Cadila Pharmaceuticals many years ago. This immunotherapy treatment, which boosts “innate immunity”, was initially approved by the Drug Controller General of India (DCGI) for gram negative sepsis which is a disease caused by bacteria.
CSIR got the approval to test “Sepsivac” against Covid-19 in a Phase 2 clinical trial about 10 days ago. The trial is being conducted on 50 patients at the All India Institute of Medical Sciences (AIIMS), New Delhi, AIIMS Bhopal, and Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh.
“We expect the results from this Phase 2 trial within 30-45 days from now. And if the results are encouraging, we will seek approval from the drug controller because of emergency and keep on continuing the Phase 3 trial. That’s how it happens,” Ram Vishwakarma, Director, Integrative Medicine (Council of Scientific & Industrial Research), Jammu, told IANS.
Meanwhile, Vishwakarma informed that CSIR has also got approval for conducting Phase 3 clinical trial of “Sepsivac” against Covid-19.
“The Phase 3 trials will be done on 1,100 people — 600 will be those who have tested positive but non- symptomatic, and 500 will be those who are out of hospital,” Vishwakarma said. “Sepsivac will be an immunomodulator, which will have protective effect and therapeutic effect both,” he said.
Sepsivac contains mycobacterium, an immunomodulator which is a non-pathogenic mycobacterium. As a result of the immunomodulator effect, Sepsivac effectively saves more lives in sepsis. Randomized trials in sepsis patients showed 11% absolute reduction and 55.5% relative reduction in mortality.