Study registration: *
Publication Manley HJ, medRxiv, 2021
Dates: 2021-02-01 to 2021-08-27
Funding: No specific funding
Conflict of interest: no COI (The authors have declared no competing interest.)

Methods

Study design:Cohort
Description of participants: Adult maintenance dialysis (home and in center) without known prior COVID-19 infection treated at Dialysis Clinic, Inc. in USA.
Inclusion criteria:
  • All adult (age ≥18 years) maintenance dialysis (home and in-center) patients without known prior COVID-19 infection prior to February 1, 2021 treated at Dialysis Clinic, Inc. (DCI) outpatient dialysis clinics between February 1 and August 26, 2021.

Exclusion criteria:
  • Transient patients (e.g. visiting from a non-DCI clinic)
  • Patients treated for acute kidney injury who were not designated as end-stage renal disease (ESRD).

Follow-up duration (months): 6.9
Vaccines:
  • 2 doses of BNT162b2 or mRNA-1273 or 1 dose of Ad26.COV2.S
  • 1 dose of Ad26.COV2.S
  • 1 or 2 doses of BNT162b2
Variant description :
Variant name: Delta
Evidence: Indirect evidence (prevalence of variant in the population: 1 to 99%)
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing stated: Yes
Data accessibility: Data available upon request
General comment The main concern is the potential for uncontrolled confounding, particularly by calendar time and symptoms at the time of potential vaccination.