Outcomes
death, anaphylaxis, TEAEs, abnormal bleeding, garadacimab
INFECTIOUS DISEASES, THROMBOEMBOLIC EVENT, ANAPHYLAXIS, ALLERGY, ADVERSE EVENT, ABNORMAL BLEEDING, EVENTS, HYPERSENSITIVITY
Primary efficacy endpoint was the incidence of progression to tracheal intubation (TI) or death before TI from randomisation to Day 28 with garadacimab compared with placebo. Secondary efficacy endpoints included all-cause mortality, incidence of TI from randomisation to Day 28, clinical status as assessed on an 8-point National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale, use of continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BiPAP), use of high-flow nasal cannula (HFNC), median change in Sequential Organ Failure Assessment (SOFA) score and median hospital length of stay. The pharmacokinetics of garadacimab was also assessed with full details to be presented elsewhere.In this study, the number and percentage of patients who experienced an adverse event (AE) on or after administration of garadacimab or placebo [i.e. a treatment-emergent AE (TEAE)] was assessed. TEAEs, serious TEAEs and AEs of special interest (AESI: abnormal bleeding events, thromboembolic events and severe hypersensitivity, including anaphylaxis) were reported. AEs were coded using the Medical Dictionary for Regulatory Activities version 21.1 (or higher).