CLINICAL TRIAL CoVigi
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.
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.
OVERVIEW OF RECRUITMENT
Recruitment for the CoVigi study is now closed. Enrolled patients continued to be visited at the centres and their immunity was monitored over time.
Centres involved: Masaryk Institute of Oncology, Internal Hematology and Oncology Clinic (FN Brno), Department of Clinical Microbiology and Immunology (FN Brno)
END OF STUDY
The visits of the enrolled patients to the centres have been completed and the data are now being prepared for analysis.
Important links to the project
| Access to REDCap database (for examiners) | ECRIN protocol summary in ENG | EU Clinical Trials Register |
| Press Conference Report | Publications in Annals of oncology |
Project documents
Contact
Project manager:
MVDr. Kateřina Janská | katerina.janska@med.muni.cz