Z99.2 U07.1
Conditions
Interventions
Group 1: Patients on dialysis (Hemo- or peritonealdialysis for longer than 1 month)
Group 2: Patients without chronic kidney disease (45 ml/min/1.73m2))
Sponsors
Nierenzentrum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Arm 1: Patients on dialysis; hemo- or peritonealdialysis for longer than 1 month; no current immunosupppressive medication; no active malignancy; >18years of age. Arm 2: patients without chronic kidney disease (>CKD Stadium 3b, eGFR >45ml/min/1.73m2); no immunosuppresssive medication; no active malignancy; >18years of age.
Exclusion criteria
Exclusion criteria: No informed consent available; not meeting above mentioned eligibility criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SARS-CoV-2 specific immunity after SARS-CoV-2 antigen exposure 1) Antibody-mediated immune response 28-42 days (=d) after SARS-CoV-2 antigen exposure (infection OR vaccination). Quantificatino of SARS-CoV-2 specific antibodies (IgG against nucleocapsid-antigen; IgG and IgM against receptor-binding-domain of S1-antigen) 2) Cellular immunity 28-42d after SARS-CoV-2 antigen exposure (infection OR exposure). Evaluation of SARS-CoV-2 antigen-specific t-cellular response by FACS-anaylsis | — |
Secondary
| Measure | Time frame |
|---|---|
| SARS-CoV-2 specific immunity after SARS-CoV-2 antigen exposure, maximum of 10 measurements per patient, depending on availability 1) Antibody-mediated immune response, same as in primary outcome measures, at further time points (14-21d, 42-56d, 56-70d, 84-94d, 112-126d, 140-154d, 168-182d, 196-210d) after SARS-CoV-2 antigen exposure 2) Evaluation of cellular immunity as in primary outcome measures, at further time points (14-21d, 42-56d, 56-70d, 84-94d, 112-126d, 140-154d, 168-182d, 196-210d) after SARS-CoV-2 antigen exposure | — |
Countries
Germany
Contacts
Public ContactClaudius Speer
Nierenzentrum Heidelberg
Outcome results
None listed