Study design
COVID-19 disease
RECRUITMENT, APPENDIX
The COVID-PREVENT trial was an open-label, multicenter, randomized, controlled clinical trial in patients with moderate to severe COVID-19 disease and a high prothrombotic risk defined by an elevated The study protocol was approved according to local regulatory requirements by the ethics committee and the Federal Institute for Drugs and Medical Devices. The study protocol inclusive its amendments and adaptions were registered at clinicaltrials.gov (NCT044160048). An independent data safety monitoring board was assigned to monitor the trial for efficacy and safety. Due to the decreasing incidence of COVID-19 in Germany during the third wave in spring 2021 and the likelihood not to be able to recruit the initially planned number of patients in a timely manner, the steering committee decided to stop the recruitment in June 2021. The approved protocol version with the summary of changes in protocol version 2.0 are provided in the Supplementary Appendix 1.