CLINICAL TRIAL SolidAct
European DisCoVeRy for Solidarity (EU-SolidAct): a clinical trial with an adaptive platform design for pandemics and emerging 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:
1. Sub-protocol Bari-SolidAct
The treatment of COVID-19 is still a major challenge for medical research, so new drugs are being investigated or the use of existing drugs is being optimized. One option to use an existing registered drug is a treatment with a janus kinase (JAK) inhibitor called baricitinib. The Bari-SolidAct clinical trial arm 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 enrolled in the study. Recruitment into the Bari-SolidAct arm was terminated as of December 16, 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 enrolled in the Czech Republic (100), 0 patients are currently enrolled. Recruitment was completed on 16 December 2022.
2. Sub-protocol AXL-SolidAct
The second newly developed arm of AXL-SolidAct uses the highly selective AXL tyrosine kinase inhibitor Bemcentinib. The primary objective of AXL-SolidAct is to evaluate the effect of bemcentinib + standard care versus placebo + standard care on disease status in hospitalized patients with moderate COVID-19 disease.
The AXL-SolidAct study was initiated in the Czech Republic in October 2022. Of the total number of patients planned to be enrolled in the Czech Republic (25), 0 patients are currently enrolled.
The sponsor of the multicentre clinical study is Oslo University Hospital, which is implementing the study in one centre in the Czech Republic through VI CZECRIN.
Important project links and documents
Contact
Study sponsor:
Inge Christoffer Olsen (Oslo University Hospital) | incols@ous-hf.no
Project Manager:
Ing. Karolína Grodová | karolina.grodova@med.muni.cz