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?:abstract
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Background: New treatment platforms that can prevent acute respiratory distress syndrome (ARDS) or reduce its mortality rate in high-risk coronavirus disease 2019 (COVID-19) patients, such as those with an underlying cancer, are urgently needed Rejuveinix (RJX) is an intravenous formulation of anti-oxidants and anti-inflammatory agents Its active ingredients include ascorbic acid, cyanocobalamin, thiamine hydrochloride, riboflavin 5\' phosphate, niacinamide, pyridoxine hydrochloride, and calcium D-pantothenate RJX is being developed as an anti-inflammatory and anti-oxidant treatment platform for patients with sepsis, including COVID-19 patients with viral sepsis and ARDS Here, we report its clinical safety profile in a phase 1 clinical study (ClinicalTrials gov Identifier: NCT03680105) and its potent protective activity in the lipopolysaccharide galactosamine (LPS-GalN) mouse model of ARDS Methods: A phase 1, double-blind, placebo-controlled, randomized, two-part, ascending dose-escalation study was performed in participating 76 healthy volunteer human subjects in compliance with the ICH (E6) good clinical practice guidelines to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of RJX (Protocol No RPI003;ClinicalTrials gov Identifier: NCT03680105) The ability of RJX to prevent fatal shock, ARDS, and multi-organ failure was examined in the well-established LPS-GalN mouse model of sepsis and ARDS Standard methods were employed for the statistical analysis of data in both studies Findings: In the phase 1 clinical study, no participant developed serious adverse events (SAEs) or Grade 3-Grade 4 adverse events (AEs) or prematurely discontinued participation in the study In the non-clinical study, RJX exhibited potent and dose-dependent protective activity, decreased the inflammatory cytokine responses (interleukin-6, tumor necrosis factor alpha, transforming growth factor beta), and improved survival in the LPS-GalN mouse model of sepsis and ARDS Histopathological examinations showed that RJX attenuated the LPS-GalN induced acute lung injury (ALI) and pulmonary edema as well as liver damage Conclusion: RJX showed a very favorable safety profile and tolerability in human subjects It shows potential to favorably affect the clinical course of high-risk COVID-19 by preventing ARDS and its complications
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