Registry of Sustained Immunity to COVID-19 Among ESKD Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Registry of Sustained Immunity to COVID-19 Among ESKD Patients

Conditions
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SARS-CoV-2 Infection, Anti-SARS-CoV-2 Infection

Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunoglobulin G, Immunoglobulin M