Papi, Alberto http://orcid.org/0000-0002-6924-4500
Stapleton, Renee D.
Shore, Paul M.
Bica, Mihai Alexandru
Chen, Younan
Larbig, Michael
Welte, Tobias
Clinical trials referenced in this document:
Documents that mention this clinical trial
Efficacy and Safety of Garadacimab in Combination with Standard of Care Treatment in Patients with Severe COVID-19
https://doi.org/10.1007/s00408-023-00615-9
Funding for this research was provided by:
CSL Behring
Università degli Studi di Ferrara
Article History
Received: 19 December 2022
Accepted: 21 March 2023
First Online: 31 March 2023
Declarations
:
: 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.
: The 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.
: All patients or caregivers provided written informed consent before screening.