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

Sponsor
Davita Clinical Research (Industry)
Overall Status
Completed
CT.gov ID
NCT04495764
Collaborator
(none)
2,315
Enrollment
12
Locations
6.8
Actual Duration (Months)
192.9
Patients Per Site
28.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    2315 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Registry of Sustained Immunity to COVID-19 Among ESKD Patients
    Actual Study Start Date :
    Jul 20, 2020
    Actual Primary Completion Date :
    Feb 12, 2021
    Actual Study Completion Date :
    Feb 12, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Anti-SARS-CoV-2 antibodies [Through study completion (5 visits), an average of 6 months]

    2. Incidence and severity of COVID-19 [Through study completion (5 visits), an average of 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 DCR Victorville Victorville California United States 92394
    2 DCR Connecticut Bridgeport Connecticut United States 06606
    3 DCR Twin Cities Minneapolis Minnesota United States 55404
    4 DCR Las Vegas Las Vegas Nevada United States 89128
    5 DCR Bronx Bronx New York United States 10461
    6 DCR Canton Canton Ohio United States 44718
    7 DCR El Paso El Paso Texas United States 79925
    8 DCR Lewisville Lewisville Texas United States 75057
    9 DCR San Antonio San Antonio Texas United States 78215
    10 DCR San Antonio San Antonio Texas United States 78230
    11 DCR Norfolk Norfolk Virginia United States 23502
    12 DCR Milwaukee Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Davita Clinical Research

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Davita Clinical Research
    ClinicalTrials.gov Identifier:
    NCT04495764
    Other Study ID Numbers:
    • 20-M-0044-00
    First Posted:
    Aug 3, 2020
    Last Update Posted:
    May 27, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Davita Clinical Research
    Immunoglobulin G
    Immunoglobulin M
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    COVID-19

    Study Results

    No Results Posted as of May 27, 2021