Rationale for a randomized, placebo-controlled, Phase 2 study of Rejuveinix (RJX) in COVID-19 patients with acute lung injury and hypoxemic respiratory failure

Author(s): Kristina Cabala, Jackie Earabino, Peter Pacult, Fatih M. Uckun*

New drug products that can effectively improve the ability of supportive care to reduce the risk of ARDS or its mortality rate in COVID-19 patients are urgently needed. Rejuveinix (RJX) is a formulation of physiologically compatible active ingredients, including several vitamins, such as ascorbic acid, cyanocobalamin, thiamine hydrochloride, riboflavin 5' phosphate, niacinamide, pyridoxine hydrochloride, calcium d-pantothenate that exhibited promising anti-ARDS activity in animal models of sepsis and ARDS as well as clinical studies in patients with sepsis, septic shock, and ARDS. RJX could favorably affect the patient journey in COVID-19 at multiple stages, including (i) prevention of progression of mild disease, (ii) faster resolution of ARDS, prevention of multi-organ failure, and reduction of case mortality during respiratory failure, and (iii) improved long-term healing after recovery. Here we are reporting the critical design elements for a two-cohort, two-part placebo-controlled, and double-blind Phase II study of RJX in COVID-19 patients.