Efficacy and Safety of Garadacimab in Combination with Standard of Care Treatment in Patients with Severe COVID-19.

"Declarations Competing InterestsML was the study investigator for this study. PS, MAB, YC and ML are employees of CSL Behring. YC holds stocks in CSL Behring. ML received funding from CSL Behring. FH was a member of the Data and Safety Monitoring Board for this study and has received honoraria for meetings and participation in advisory boards from CSL Behring. The authors report no other conflicts of interest in this work. Ethical ApprovalThe phase 2 study (ClinicalTrials.gov, NCT04409509) was approved by the authorised Institutional Review Boards or Independent Ethics Committees of the 14 study sites in the USA and conducted in accordance with the principles of Good Clinical Practice. Consent to ParticipateAll patients or caregivers provided written informed consent before screening. Competing Interests ML was the study investigator for this study. PS, MAB, YC and ML are employees of CSL Behring. YC holds stocks in CSL Behring. ML received funding from CSL Behring. FH was a member of the Data and Safety Monitoring Board for this study and has received honoraria for meetings and participation in advisory boards from CSL Behring. The authors report no other conflicts of interest in this work."

"Funding Open access funding provided by Università degli Studi di Ferrara within the CRUI-CARE Agreement. This study was funded by CSL Behring."

"ClinicalTrials. gov Identifier NCT04409509. Date of registration: 28 May, 2020."