Table 3.

Clinical endpoints LESS-CoV-2 study

Primary endpoint

Incidence (per person-year) of COVID-19 in a two-years period after SARS-CoV-2 vaccination in patients with CKD stage G4-G5 or on KRT.

Secondary endpoints

Efficacy

• The antibody based immune response to SARS-CoV-2 vaccination at 28 days after SARS-CoV-2 vaccination.

• The durability of the antibody response at 6 months after SARS-CoV-2 vaccination

Safety

• Incidence of mortality

• Incidence of AEs of specific interest as defined by (inter) national authorities

• Incidence of a combined endpoint of acute rejection or graft failure in kidney transplant recipients

• Incidence of HLA antibodies defined as cPRA > 5% in dialysis patients on the waiting list for their first kidney transplantation

Exploratory endpoints

Vaccination coverage rates

Disease severity in patients who develop COVID-19, assessed as

• Hospitalization

• ICU admission

• Mechanical ventilation

PROMs in patients on dialysis

SARS-CoV2 genotype in patients with COVID-19 (in case available)

COVID-19 Coronavirus Disease 2019, SARS-CoV-2 Severe Acute Respiratory Syndrome Coronavirus-2, CKD Chronic Kidney Disease, KRT Kidney Replacement Therapy, AEs Adverse Events, HLA Human Leukocyte Antigen, cPRA Calculated Panel Reactive Antibody, ICU Intensive Care Unit, PROMs Patient Reported Outcome Measures