Repurposing of Mycobacterium indicus pranii for the severe form of COVID-19 patients in India: A cohort study.

Abstract

Severe acute respiratory syndrome coronavirus‐2 (SARS‐CoV‐2) induces the production of proinflammatory cytokines, which results in a cytokine storm, and immune‐modulators like Mycobacterium indicus pranii (MIP) might ameliorate coronavirus disease of 2019 (COVID‐19) related cytokine storm. Therefore, the present study evaluates whether MIP offers an advantage in the treatment of severe COVID‐19 patients infected with SARS‐CoV‐2. A prospective MIP cohort study was conducted in chest disease hospitals in Srinagar, Jammu and Kashmir, India. In the present prospective, randomized clinical study, critically severe COVID‐19 patients were divided into two groups, the MIP group (n = 105) and the best standard treatment (BST) group (n = 210). Procalcitonin, ferritin, high‐sensitive C‐reactive protein, D‐dimer levels, and interleukin levels on 5th‐day posttreatment were significantly reduced in the MIP group compared to the BST group. Compared to the BST group, 105 consecutive patients with severe COVID‐19 in the MIP group reported early weaning off ventilation, resolution of chest architecture (computed tomography [CT] scan), a significant increase in SpO2 levels, and decreased mortality with a hazard ratio: 0.234 (95% confidence interval: 0.264–2.31) (p = 0.001). MIP restored SpO2, immune/inflammatory response, normalized lung abnormalities (chest CT scan), and reduced mortality without any serious complications. However, there is a need for placebo‐controlled double‐blind and controlled clinical trials to confirm the efficacy.