Conclusion
garadacimab, HAE, bleeding
EVENTS, BLEEDING, DISEASES
In patients with severe COVID-19, garadacimab did not confer a clinical benefit over placebo. Transient aPTT prolongation and suppressed FXIIa-mKA showed target engagement of garadacimab with no associated bleeding events, even with co-administered anticoagulation therapy. The safety profile of garadacimab was benign, consistent with previous studies in healthy volunteers and patients with HAE. These promising safety findings provide important supporting evidence for the ongoing clinical development of garadacimab in other diseases.