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 SpO 2 levels, and decreased mortality with a hazard ratio: 0.234 (95% confidence interval: 0.264-2.31) (p = 0.001). MIP restored SpO 2 , 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.
Keywords: COVID-19; Mycobacterium indicus pranii; interleukins; mechanical ventilation; proinflammatory response and oxygen saturation.
【저자키워드】 COVID-19, Interleukins, mechanical ventilation, Mycobacterium indicus pranii, proinflammatory response and oxygen saturation., 【초록키워드】 Treatment, coronavirus disease, SARS-CoV-2, Efficacy, Cytokine storm, Mortality, severe COVID-19, hospital, India, Ventilation, Proinflammatory response, C-reactive protein, ferritin, cohort study, Computed tomography, Randomized, oxygen saturation, Chest, complications, proinflammatory cytokines, disease, placebo-controlled, Coronavirus-2, clinical study, chest CT scan, double-blind, acute respiratory syndrome, two groups, D-dimer levels, decreased mortality, Controlled clinical trial, standard treatment, significant increase, Mycobacterium, offer, MIP, evaluate, significantly, reported, conducted, reduced, induce, restored, BST, consecutive patient, infected with SARS-CoV-2, Jammu and Kashmir, lung abnormality, normalized, severe COVID-19 patient, 【제목키워드】 repurposing, cohort study, COVID-19 patient, Mycobacterium,