294: Auxora Improves D-Dimer Levels in Patients With Severe COVID-19 Pneumonia

INTRODUCTION: Calcium release-activated calcium (CRAC) channel inhibitors stabilize the pulmonary endothelium and block proinflammatory cytokine release, potentially mitigating respiratory complications in patients with COVID-19 D-dimer levels have been correlated with disease severity and risk of mortality in patients with COVID-19 The effect of CRAC channel inhibition on D-dimer levels was investigated METHODS: The safety and efficacy results of a randomized, controlled, open-label study comparing Auxora, a novel, intravenously administered CRAC channel inhibitor, to standard of care (SOC) in adults with severe/critical COVID-19 pneumonia have been previously reported In this study, D-dimer levels were recorded at baseline and every 48 hours thereafter Shortages of Personal Protective Equipment for laboratory personnel at 2 sites and restrictions in shipments of blood samples containing SARS-CoV2 at one site prevented laboratory personnel from drawing blood at times outlined in the protocol Consequently, a limited number of patients had blood samples drawn prior to randomization RESULTS: In total, 17 patients with severe COVID-19 pneumonia were randomized to Auxora and 9 to SOC All patients received anticoagulation according to SOC Over the course of this study, D-dimer levels decreased in patients receiving Auxora but increased in those receiving SOC From baseline to 48 hours, the median change was -0 24 μg/ mL for patients receiving Auxora (n=10) and 0 63 μg/mL in patients receiving SOC (n=8), and from baseline to 96 hours the median change was -0 85 μg/mL (n=6) and 0 07 μg/mL (n=3), respectively Two patients receiving SOC developed femoral deep vein thrombosis No patients receiving Auxora developed thromboembolic disease In the 30 days postrandomization, 2 patients receiving Auxora and 2 receiving SOC died due to respiratory failure, all of whom experienced >100% increase in D-Dimer levels in the first 48 hours CONCLUSIONS: Auxora demonstrated improved D-dimer levels as early as 48 hours and as previously reported, a favorable safety profile and improved clinical outcomes Results from this study suggest that a >100% increase in D-dimer levels in the first 48 hours may identify patients with severe COVID-19 at risk for mortality from respiratory failure