COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000412-28/BE

Hopital Erasme, Université Libre de Bruxelles - data manager

delphine.kemlin@erasme.ulb.ac.be

2021-02-04

nonRCT

Non-randomized

Single group assignment

Open label

single-center

Prevention

- Age of 18 years old or older - Patients should met one of the cohort criteria - life expectancy > 12 months - Ability to provide informed consent

- women who are pregnant or breastfeeding. To reflect the real-world population of kidney transplant patients, the NEPHRO-VAC transplantation project is designed as inclusive as possible. Exclusion criteria are minimal and serve to exclude patients who are not evaluable, or in whom vaccination is considered not safe or not effective. Since baseline blood samples before vaccination will provide an individual reference level of antibody measures, potential bias can be anticipated for. As such, we can still evaluate the immune response induced by the vaccination only. Moreover, At baseline (ie before vaccination) blood samples will be taken. The existence of SARS-Cov-2 antibodies will be examined in the samples in retrospect. As such, based on the baseline antibody levels, we can divide the study population in a COVID+ and COVID- subgroup and perform subgroup analysis to evaluate the effect of this variable. We feel it is not feasible and necessary to exclude patients for the trial based on prevaccination SARS-CoV-2 antibody positivity. First of all the procedures in the study reflect the real life situation. Secondly, analyzing the study results the revaccination antibody levels will be a variable used in the analysis.

1

Hopital Erasme, Université Libre de Bruxelles

18

100

Belgium

High risk patients

N/A

80

ELISA RBD antibodies (IgG) 28 days after booster dose. For those with a previous COVID infection, the in house multiplex assay from Sciensano will be performed to discriminate between previous infection and vaccination

nan

Phase 4

[{"arm_notes": "30\u00b5g;2", "treatment_id": 339, "treatment_name": "Covid-19 mrna vaccine (nucleoside-modified)", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]