Status:
COMPLETED
RECOVAC - Long Term Efficacy and Safety of COVID-19 (SARS-CoV-2) Vaccination in Kidney Disease Patients
Lead Sponsor:
University Medical Center Groningen
Conditions:
Covid19
SARS-CoV Infection
Eligibility:
All Genders
18+ years
Brief Summary
Rationale: COVID-19 is associated with severely increased morbidity and mortality in patients with chronic kidney disease stage G4-G5 and patients on dialysis or after kidney transplantation. Therefor...
Detailed Description
1. OBJECTIVES Primary objective: To assess the efficacy of SARS-CoV-2 vaccination by the incidence of COVID-19 in patients with chronic kidney disease stage G4-G5, on dialysis and patients aft...
Eligibility Criteria
Inclusion
- Eligible for COVID-19 vaccination as described by the instructions of the manufacturer.
- Age of 18 years or older
- Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained)
- Either
- eGFR \< 30 ml/min/1.73m2 but not on dialysis or with a kidney transplant
- Hemodialysis, or peritoneal dialysis
- Kidney Transplant recipient at least 6 weeks after transplantation
Exclusion
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s).
- Patients who opted out for research in the Santeon, RENINE and NOTR registries.
- Patients who participate in the RECOVAC-IR study.
- Of note, patients will be eligible whether or not they have a history of COVID-19. Analyses will be performed in the overall population, but also shown separately for those without and with a history of COVID-19.
Key Trial Info
Start Date :
April 22 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 18 2023
Estimated Enrollment :
4868 Patients enrolled
Trial Details
Trial ID
NCT04841785
Start Date
April 22 2021
End Date
December 18 2023
Last Update
March 18 2024
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ