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April 23, 2020

Drugs Controller General of India approves Clinical Trials of an approved immunomodulator, Sepsivac®, to Enhance Innate Immunity of the Body to Limit the Spread of COVID-19 and Fasten the Recovery of COVID-19 Patients.

India Covid Drug

New Delhi, April 23, 2020 — Natural defense mechanism of the body (innate immunity) plays a crucial role in the fight against COVID-19 and other viral infections. It is a fast, first, and efficient immune response for identifying and eliminating COVID-19 and other viruses. The majority of persons coming in contact with COVID-19 or other illnesses either do not get the disease or get a milder form of the self-limiting disease if innate immunity is adequate. Cells of the human immune system like Macrophages, NK cells offer such protection.

India’s Ministry of Science & Technology provided this information today.

While the world is working towards producing vaccines and antiviral agents for the management of COVID-19, the Council of Scientific and Industrial Research (CSIR), India, has decided to develop/repurpose an approved immunomodulator, Sepsivac®. The medicine would enhance the innate immunity of the body, limit the spread of COVID-19, and fasten the recovery of the patients.

Sepsivac® would act as follows:

1. Protect the close contacts of COVID-19 patients and health care staff by boosting their innate response and thereby preventing them from acquiring the disease.

2. Provide quicker recovery to the hospitalized COVID-19 patients, who are not critically ill. It will also prevent the progression of the illness, wherein patients will need ICU management.

The Drugs Controller General of India (DCGI) has now approved both these new clinical trials. They will be randomized, double-blind, two-arm, controlled clinical trials. These two clinical trials are in addition to the recently announced test on evaluating the efficacy of the drug for reducing mortality in critically ill COVID-19 patients.

Sepsivac® contains heat-killed Mycobacterium W (Mw). It is exceptionally safe in patients, and no systemic side effects are associated with its use, India’s Ministry of Science & Technology elaborated.

Sepsivac®, developed under the NMITLI (New Millennium Indian Technology Leadership Initiative) program of CSIR (Council of Scientific and Industrial Research), is manufactured by Cadila Pharmaceuticals Ltd., Ahmedabad.

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Edited & Posted by the Editor | 1:08 PM | Link to this Post

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