Clinical trial on sepsis drug for Covid-19 patients to start soon

Shimona Kanwar | TNN | Updated: Apr 22, 2020, 11:43 IST

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CHANDIGARH: A drug clinically developed in 2012 by PGIMER for gram negative sepsis — a severe infection of blood — will be now tested on patients with severe form of Covid-19. The drug for sepsis, in form of intradermal injection, has been a game changer for blood infection as it has reduced mortality rate by 50%.
The randomised control trial, approved by the Drug Controller General of India, will be conducted in three hospitals — PGIMER, AIIMS Delhi and AIIMS Bhopal.
This drug, used for gram negative sepsis, has been developed by Cadila Pharmaceuticals Ltd Ahmedabad under the New Millennium Indian Technology Leadership Initiative programme of Council of Scientific and Industrial Research (CSIR). “ The drug modulates immune system of the body and thereby inhibits the cytokine storm, leading to reduced mortality and faster recovery,” said Dr Shekhar Mande, director-general CSIR. “We have got approval for the trials. AIIMS Bhopal has got its nod from the ethics committee. We shall soon get from the other two institutes.”
Trial will continue for up to 6 months
The randomised control trial will enrol 40 patients. Eligible patients will be enrolled after due consent — 20 will receive either test drug (along with the standard of care) and the remaining 20 will have water for injection (along with the standard of care). “We have sent protocol to the Institute Ethics Committee (IEC) for its approval. The nod will be given immediately. We will start enrolling patients soon after this. There is hope that we will be managing mortality with this,” said Prof Jagat Ram, director PGIMER.
The enrolled patients will be monitored for any adverse events or serious adverse events throughout the study period. The trial will continue for a maximum period of six months. As these patients are critical and their relatives will be quarantined, the consent will be verbal and not written.
“The clinical trial of ‘mycobacterium w’ in severe sepsis was conducted in PGI. The phase II-b trial was funded by CSIR and Cadila was the study coordinator. The trial was a multicentric trial and involved patients with severe sepsis. The trial was completed in October 2019 where we had better outcome. Based on the results of our study, DGCI has approved the use of ‘mycobacterium w’ in patients with severe sepsis,” said Dr Inderpaul Sehgal, department of pulmonary medicine , PGI, and investigator of the trial.