{"id":9056,"date":"2022-02-16T11:41:00","date_gmt":"2022-02-16T10:41:00","guid":{"rendered":"https:\/\/czecrin.cz\/project\/kh-solidact\/"},"modified":"2026-01-06T09:59:56","modified_gmt":"2026-01-06T08:59:56","slug":"kh-solidact","status":"publish","type":"project","link":"https:\/\/czecrin.cz\/en\/project\/kh-solidact\/","title":{"rendered":"KH SolidAct"},"content":{"rendered":"\n

CLINICAL TRIAL SolidAct<\/h3>\n\n\n\n
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European DisCoVeRy for Solidarity (EU-SolidAct): a clinical trial with an adaptive platform design for pandemics and emerging infections<\/p>\n\n\n\n

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: <\/p>\n\n\n\n

1. Sub-protocol Bari-SolidAct<\/h6>\n\n\n\n

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. <\/p>\n\n\n\n

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. <\/p>\n\n\n\n

2. Sub-protocol AXL-SolidAct<\/h6>\n\n\n\n

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. <\/p>\n\n\n\n

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. <\/p>\n\n\n\n

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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.<\/p>\n\n\n\n

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Important project links and documents<\/h2>\n\n\n\n
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EU Clinical Trials Database<\/strong><\/a><\/td>EU Clinical Trials Register – original, Bari-SolidAct arm<\/a><\/strong><\/td>KH registration on ClinicalTrials.gov<\/a><\/strong><\/td><\/tr>
Official project website<\/a><\/strong><\/td>EU-SolidAct Protocol<\/a><\/strong><\/td>Bari-SolidAct Protocol<\/a><\/strong><\/td><\/tr>
AXL-SolidAct protocol<\/a><\/strong><\/td>KH MEK FNUSA<\/a><\/strong><\/td><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
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Contact<\/h5>\n\n\n\n

Study sponsor:
Inge Christoffer Olsen (Oslo University Hospital) | incols@ous-hf.no<\/a><\/p>\n\n\n\n

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Project Manager:
Ing. Karol\u00edna Grodov\u00e1 | karolina.grodova@med.muni.cz<\/a><\/p>\n\n\n\n

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