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LESS CoV-2
The RECOVAC LESS CoV-2 Study - Long Term Efficacy and Safety of SARS-CoV-2 Vaccination in Patients in Patients With Chronic Kidney Disease Stage G4-G5, on Dialysis or After Kidney Transplantation
Sponsor study identifier
observational
4,868
1 country
1
Study Start
April 22, 2021
Actual (reported)Primary Completion
November 30, 2021
Actual (reported)Study Completion
December 18, 2023
Actual (reported)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. Therefore, effective SARS-CoV-2 vaccination would be of great clinical importance in these patients. However, SARS-CoV-2 vaccination studies have excluded these patients so-far. Literature data indicate that vaccination may be less effective in these patient groups. Objective: To assess the efficacy and safety of SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, patients on dialysis or after kidney transplantation during two years follow-up after vaccination. Study design: prospective single center observational cohort study. Study population:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 18, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 22, 2021
Actual (reported)April 12, 2021
Actual (reported)April 22, 2021
Actual (reported)November 30, 2021
Actual (reported)December 18, 2023
Actual (reported)The incidence of COVID-19
After SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation.
two years after SARS-CoV-2 vaccination
Incidence of mortality
two years after SARS-CoV-2 vaccination
Incidence of adverse events
two years after SARS-CoV-2 vaccination
Patients with chronic kidney disease stage G4-G5 without dialysis or with a kidney transplant
Patients on hemodialysis and peritoneal dialysis
Patients with a kidney transplant at least 6 weeks after transplantation
All participants in the antibody measurement study will be sent a mailer-based finger-prick set. The sets will be sent to the home address of the patient, including a return envelope. After collecting and returning the samples SARS-CoV-2 antibodies will be analysed quantitatively at the laboratory.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
* Patients with chronic kidney disease stage G4-G5 from the Santeon registry * Patients on hemodialysis and peritoneal dialysis who gave informed consent for participating in the national registry RENINEKidney transplant recipients who gave informed consent for participating in the national registry NOTR
University Medical Center Groningen
Groningen, 9713 GZ, Netherlands
Ahn C, Amer H, Anglicheau D, Ascher NL, Baan CC, Battsetset G, Bat-Ireedui B, Berney T, Betjes MGH, Bichu S, Birn H, Brennan D, Bromberg J, Caillard S, Cannon RM, Cantarovich M, Chan A, Chen ZS, Chapman JR, Cole EH, Cross N, Durand F, Egawa H, Emond JC, Farrero M, Friend PJ, Geissler EK, Ha J, Haberal MA, Henderson ML, Hesselink DA, Humar A, Jassem W, Jeong JC, Kaplan B, Kee T, Kim SJ, Kumar D, Legendre CM, Man K, Moulin B, Muller E, Munkhbat R, Od-Erdene L, Perrin P, Rela M, Tanabe K, Tedesco Silva H, Tinckam KT, Tullius SG, Wong G. Global Transplantation COVID Report March 2020. Transplantation. 2020 Oct;104(10):1974-1983. doi: 10.1097/TP.0000000000003258. No abstract available.
Baric RS. Emergence of a Highly Fit SARS-CoV-2 Variant. N Engl J Med. 2020 Dec 31;383(27):2684-2686. doi: 10.1056/NEJMcibr2032888. Epub 2020 Dec 16. No abstract available.
Blood (in total maximum 1 mL) with a mailer-based finger-prick will be drawn
Jan-Stephan F Sanders, MD PhD
University Medical Center Groningen
Marc H Hemmelder, MD PhD
Maastricht University Medical Center
4,868 participants (actual enrollment reported by the registry).
First Submitted
March 22, 2021
First Posted
April 12, 2021
Study Start
April 22, 2021
Actual (reported)Incidence of acute rejection or graft failure in kidney transplant recipients
two years after SARS-CoV-2 vaccination
Incidence of HLA antibodies measured in blood
two years after SARS-CoV-2 vaccination
The antibody level against the SARS-CoV-2 Receptor Binding Domain measured in blood
28 days after second SARS-CoV-2 vaccination.
Vaccination coverage rate
two years
SARS-CoV-2 genotype
two years
Level of SARS-CoV-2 Receptor Binding Domain antibody in patients with and without COVID-19
two years
Contact the study team to confirm eligibility.
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Primary Completion
November 30, 2021
Actual (reported)Study Completion
December 18, 2023
Actual (reported)Last Updated
March 18, 2024
Record last verified: 2024-03
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Source: ClinicalTrials.gov.
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