Trial design
arrhythmias, coronavirus disease 2019
ARRHYTHMIAS, CORONAVIRUS DISEASE 2019
We conducted a phase 2 randomized, double-blind, placebo-controlled, parallel-group trial with an adaptive design with the potential to test doses between 2 and 6 mg kgThe maximum number of individuals that could be enrolled based on the adaptive design was 108. Patients wore 12-lead Holter monitors to assess both efficacy and safety for at least 8 h after the infusion; the collected data were analyzed by a core laboratory for arrhythmias and semiautomated measurement of ECG intervals based on triplicate ECG extracts at prespecified time points. Patients were followed until day 30 after receiving the infusion. Please refer to the protocol in Supplementary Note In December 2022, the sponsor decided to stop the trial early because of slow enrollment, mainly due to the coronavirus disease 2019 pandemic, at a time when the sample size in the 5 mg kgThe trial protocol was approved by the following ethics committees: Den Videnskabsetiske Komité, Region Sjælland, Denmark and Egészségügyi Tudományos Tanács Klinikai Farmakológiai Etikai Bizottsága, Budapest, Hungary.All participants provided written informed consent. The trial was sponsored and funded by Acesion Pharma.ClinicalTrials.gov registration: 