Data collection and monitoring
ADVERSE EVENTS
Demographics and medical history were collected at baseline. Physical exam findings, vital signs, concomitant medications, and adverse events were collected daily from enrollment until day 6, then again at intensive care unit (ICU) discharge and at hospital discharge. Biomarker outcomes were collected at baseline and at day 6. Biomarkers were measured using the clinical laboratory at the University of Utah from blood drawn by clinical staff at the direction of study personnel. Patient records were utilized for follow up data as needed. Trial data were maintained on-site securely using paper records and REDCap. Any adverse events were reported by study personnel to the principal investigator. Severe adverse events were then reported to the medical monitor, and then to the DSMB within 3 days of occurrence.Data were delivered securely at regular intervals to the blinded statistical analysis team, who prepared reports for DSMB review. At pre-specified intervals (after enrollment of 5, 20 and 40 patients), the DSMB convened to review study progress and outcomes and to recommended cessation or continuation of the study. DSMB also reviewed all severe adverse events and recommended cessation or continuation of the study.