{"id":9058,"date":"2022-02-16T13:00:00","date_gmt":"2022-02-16T12:00:00","guid":{"rendered":"https:\/\/czecrin.cz\/project\/kh-covigi\/"},"modified":"2026-01-06T09:58:22","modified_gmt":"2026-01-06T08:58:22","slug":"kh-covigi","status":"publish","type":"project","link":"https:\/\/czecrin.cz\/en\/project\/kh-covigi\/","title":{"rendered":"CT CoVigi"},"content":{"rendered":"\n

CLINICAL TRIAL CoVigi<\/h3>\n\n\n\n
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CoVigi is a phase IV multicentre post-registration intervention study to monitor long-term safety and efficacy after vaccination against COVID-19.The study was initiated by Masaryk University in collaboration with the University Hospital Brno and the Masaryk Cancer Institute. A total of 559 patients were enrolled and underwent a total of 8 blood draws at predefined dates over a 2-year period. Antibody levels and cellular immunity over time were subsequently determined in the blood samples. In addition, the circulating immune profile of the cancer patients was monitored. <\/p>\n\n\n\n

Once a medicine has been authorised, it is essential that its efficacy and safety continue to be monitored (pharmacovigilance). This is also true for COVID-19 vaccines, and therefore the results of studies such as the CoVigi study are indispensable for obtaining important information on the substances under investigation. <\/p>\n\n\n\n

OVERVIEW OF RECRUITMENT<\/h6>\n\n\n\n

Recruitment for the CoVigi study is now closed. Enrolled patients continued to be visited at the centres and their immunity was monitored over time. <\/p>\n\n\n\n

Centres involved: Masaryk Institute of Oncology, Internal Hematology and Oncology Clinic<\/a><\/strong> (FN Brno), Department of Clinical Microbiology and Immunology<\/a><\/strong> (FN Brno)<\/p>\n\n\n\n

END OF STUDY<\/h6>\n\n\n\n

The visits of the enrolled patients to the centres have been completed and the data are now being prepared for analysis.<\/p>\n\n\n\n

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Important links to the project<\/h2>\n\n\n\n
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Access to REDCap database (for examiners)<\/a><\/strong><\/td>ECRIN protocol summary in ENG<\/a><\/strong><\/td>EU Clinical Trials Register<\/a><\/strong><\/td><\/tr>
Press Conference Report<\/a><\/strong><\/td>Publications in Annals of oncology<\/a><\/strong><\/td><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
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Project documents<\/h2>\n\n\n\n
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Approval of KH MEK FN Brno<\/a><\/strong><\/td>Protocol Synopsis (ENG)<\/a><\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
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Contact<\/h5>\n\n\n\n

Project manager:
MVDr. Kate\u0159ina Jansk\u00e1 | katerina.janska@med.muni.cz<\/a> <\/p>\n\n\n\n

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