Registry of Sustained Immunity to COVID-19 Among ESKD Patients (RePAiR)

This is a multi-center, prospective registry study of subjects undergoing hemodialysis for treatment of end-stage renal disease in a DaVita center.

The objective of this study is to understand whether and to what degree anti-SARS-CoV-2 antibodies mitigate the risk of subsequent SARS-CoV-2 infection and COVID disease within the ESKD population.

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2 Infection; Anti-SARS-CoV-2 Infection

Detailed Description

This is a multi-center, prospective registry study of subjects undergoing hemodialysis for treatment of end-stage renal disease in a DaVita center.

The objective of this study is to understand whether and to what degree anti-SARS-CoV-2 antibodies mitigate the risk of subsequent SARS-CoV-2 infection and COVID disease within the ESKD population.

Following informed consent, participants will undergo baseline serologic characterization for anti-SARS-CoV-2 IgM and IgG. The study is planned to align with the present wave of COVID-19. Enrollment will continue until the total sample size of 2500 is reached or until the study sponsor determines. Should there be a subsequent wave of COVID- 19, participants will be actively surveiled for evidence of SARS-CoV-2 infection and for COVID-19 disease. The relationship between baseline serologic status and subsequent infection/disease will be determined.

This study will have 2 distinct phases.

Phase 1 (baseline characterization) start will be triggered by the sponsor and may start at different times at the active sites. Participants will be consented and enrolled and blood will be collected for anti-SARS-CoV-2 antibodies.

Phase 2: Start will be triggered by the sponsor in the fall of 2020 and each geographic study location may be triggered to start at separate times. Study participants will be followed prospectively for incidence and severity of COVID-19. Study visits will commence upon sponsor trigger and will occur once monthly for 4 months.

• Study Type: Observational
• Enrollment (Actual): 2315

Contacts and Locations

Study Locations

• United States
  • California
    • Victorville, California, United States, 92394
      • DCR Victorville
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • DCR Connecticut
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • DCR Twin Cities
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • DCR Las Vegas
  • New York
    • Bronx, New York, United States, 10461
      • DCR Bronx
  • Ohio
    • Canton, Ohio, United States, 44718
      • DCR Canton
  • Texas
    • El Paso, Texas, United States, 79925
      • DCR El Paso
    • Lewisville, Texas, United States, 75057
      • DCR Lewisville
    • San Antonio, Texas, United States, 78230
      • DCR San Antonio
    • San Antonio, Texas, United States, 78215
      • DCR San Antonio
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • DCR Norfolk
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • DCR Milwaukee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1. Between ≥18 and 80 years of age, inclusive.
2. Ability to provide informed consent.
3. Currently receiving hemodialysis treatment for end-stage kidney disease at a DaVita dialysis center.

Description

Inclusion Criteria:

• Between ≥18 and 80 years of age, inclusive.
• Ability to provide informed consent.
• Currently receiving hemodialysis treatment for end-stage kidney disease at a DaVita dialysis center.

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anti-SARS-CoV-2 antibodies	Through study completion (5 visits), an average of 6 months
Incidence and severity of COVID-19	Through study completion (5 visits), an average of 6 months

Collaborators and Investigators

• Sponsor: Davita Clinical Research
• Investigators: Principal Investigator: Francesca Tentori, MD, Davita Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2020
• Primary Completion (Actual): February 12, 2021
• Study Completion (Actual): February 12, 2021

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Immunoglobulin G; Immunoglobulin M
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases
• Other Study ID Numbers: 20-M-0044-00

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No