Pancreas 2021 Apr 29. Epub 2021 Apr 29.
From the Departments of Critical Care Medicine Emergency Medicine, Regions Hospital, HealthPartners, St. Paul, MN Departments of Emergency Medicine Internal Medicine, Henry Ford Hospital System Department of Emergency Medicine, Wayne State University, Detroit, MI Departments of Pulmonary Medicine Critical Care Medicine, Riverside Methodist Hospital, Columbus, OH Department of Radiology, St. Antonius Hospital, Nieuwegein, The Netherlands CalciMedica, Inc, La Jolla, CA.
Objectives: To assess the safety of Auxora in patients with acute pancreatitis (AP), systemic inflammatory response syndrome (SIRS), and hypoxemia, and identify efficacy endpoints to prospectively test in future studies.
Methods: This phase 2, open-label, dose-response study randomized patients with AP, accompanying SIRS, and hypoxemia (n = 21) to receive low-dose or high-dose Auxora plus standard of care (SOC) or SOC alone. All patients received pancreatic contrast-enhanced computed tomography scans at screenings, day 5/discharge, and as clinically required 90 days postrandomization; scans were blinded and centrally read to determine AP severity using computed tomography severity index. Read More