COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000930-32/BE

clinical trial center - CTC

ctc@azsintjan.be

2021-03-04

Completed

nonRCT

Non-randomized

Single group assignment

Open label

multi-center

Prevention

1. Consecutive series of hemodialysis patients receiving Covid-19 RNA vaccine. A target of at least 100 patients is envisioned. Minimum age for inclusion is 18 years. 2. at least thirty healthy volunteers receiving Covid-19 RNA vaccine. Minimum age for inclusion is 18 years. Individuals with immune disorders cannot participate. 3. at least thirty patients older than 50 years with at least 1 comorbidity (such as heart failure, diabetes, COPD, liver cirrhosis,....), but no chronic renal insufficiency. Minimum age for inclusion is 18 years. Only patients who receive vaccine on a voluntary basis will be included.

- patients younger than 18 years old - patients who do not voluntarily ask for a COVID-vaccination - patients not eligible according to abovementioned inclusion criteria

1

AZ Sint-Jan Brugge-Oostende AV

18

100

Belgium

High risk patients

N/A

580

1. Measurement of anti-S and anti-N antibodies. SARS-CoV-2 IgG against the S and N protein will be quantitatively measured by chemiluminescent microparticle immunoassay (Architect-I System by Abbott, Sligo, Ireland). 2. Measurement of interferon gamma production. Interferon production by SARS-CoV specific T cells will be measured using the QuantiFERON Sars-CoV-2 kit (Qiagen). 3. Baseline immune status (only in hemodialysis patients). Before vaccination the following parameters are determined: number of lymphocytes, number of CD4 positive lymphocytes, number of CD8 positive lymphocytes, number of CD19 positive lymphocytes, B and T cell memory subsets, protein electrophoresis, C3, C4, total IgG, IgA and IgM.

Declared number of arm (1.0) differs from found arms (2.0)

Phase 4

[{"arm_notes": "", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]