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European DisCoVeRy for Solidarity (EU-SolidAct): Clinical study with adaptive platform design for pandemics and new infections
Within the platform design, the study follows a generic main protocol, to which a drug-specific sub-protocol is always added. So far, there are two arms in the EU-SolidAct study:
The treatment of COVID-19 is still a major challenge for medical research, so new drugs are being explored or the use of existing drugs is being optimized. One way to use an existing authorized medicine is to use a janus kinase (JAK) inhibitor called baricitinib. The arm of Bari-SolidAct clinical trial aims to evaluate the efficacy of baricitinib in hospitalized patients with severe or critical COVID-19 disease. A total of 2,000 patients are planned to be included in the study. Recruitment to the Bari-SolidAct arm was terminated on 16 December 2022 based on the decision of the EU-SolidAct Trial Steering Committee.
The Bari-SolidAct study was initiated in the Czech Republic in February 2022. Of the total number of patients planned to be included in the Czech Republic (100), 0 patients are currently included. Recruitment closed on December 16, 2022.
The second newly established AXL-SolidAct arm uses the highly selective AXL tyrosine kinase inhibitor Bemcentinib. The primary objective of AXL-SolidAct is to evaluate the effect of bemcentinib + standard of care compared to the effect of placebo + standard of care on disease status in hospitalized patients with moderate COVID-19 disease. In total, 500 patients are planned to be included in the study.
The AXL-SolidAct study was initiated in the Czech Republic in October 2022. Of the total number of patients planned to be included in the Czech Republic (25), 0 patients are currently included.
The sponsor of the multicenter clinical study is Oslo University Hospital, which conducts the study in one center in the Czech Republic through RI CZECRIN.