Medical Sciences

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Objective: The objectives of the project are: To provide an intervention working by entirely different mechanism of action i.e. inducing innate immune response for clearance of COVID-19 as well as correcting immune dysregulation; To provide an intervention which can be easily used in future pandemics irrespective of pathogen characteristics The project consists of three trials namely: CRSC20004: A clinical trial to evaluate the safety and efficacy of Mycobacterium W in critically ill patients suffering from COVID 19 infection. CRSC20005: A Randomized, Double-blind, Two arm, Placebo Controlled Clinical Trial to Evaluate the Efficacy and Safety of Mycobacterium w in preventing COVID-19 in subjects at risk of getting infected with COVID-19. CRSC20006: A Randomized, Double-blind, Two arm, controlled clinical trial to compare the Efficacy and Safety of Mycobacterium w (Mw) administered along with Standard of care versus Placebo administered along with Standard of care, in adult, COVID 19 positive patients hospitalized but not critically ill.

Summary: Mw is commercially available in India since 1999 following approval by drug controller general of India. Its efficacy and safety is well established. It has been extensively studied for Its protective efficacy against leprosy and tuberculosis. It is found to be effective in tuberculin conversion of tuberculin negative patients (surrogate marker for prophylaxis against tuberculosis) suffering from HIV. It is also being evaluated for its efficacy to prevent tuberculosis in a cohort of house hold contacts of patients diagnosed to have sputum positive tuberculosis. Its efficacy and safety are also well established in management of various infectious diseases for faster clearance of pathogens and rapid recovery irrespective of severity of disease Mw is approved for the treatment of gram-negative sepsis on the basis of clinical trials conducted so far. The development program was supported by CSIR under NMITLI program However, it has not been evaluated during COVID-19 pandemic for its efficacy. Current proposal aims to develop and approve a safe immunomodulator for management of whole spectrum of COVID-19 infections, from prevention of disease in contacts to reducing the morbidity and mortality associated with COVID-19 by controlling dysregulated immune system through the use of Mw, in a same way as has been successfully demonstrated in critically ill patients with gram negative Sepsis. This proposal attempts to address the global unmet medical need to manage critically ill COVID-19 patients.

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