DCI COVID-19 Surveillance Project

Study Overview
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Brief Summary
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This is a prospective longitudinal census study conducted at a single center (DCI Inc., Henry Avenue, Philadelphia). The purpose of this study is to gain information about COVID-19 infection and antibody response in an in-center dialysis population. The investigators hypothesize that screening and surveillance for COVID-19 positive test (viral infection) and antibodies response to infection (potential immunity) in a dialysis center population within a high-prevalence region can provide foundational information to guide approaches toward prevention of COVID-19 related illness in a susceptible population. Participants will be given a questionnaire initially and monthly over the study period to find out whether they have had COVID-19 infection, hospitalization, or symptoms. A nasopharyngeal swab test for COVID-19 infection and a blood sample for COVID-19 antibody will be collected monthly for the study period.

Official Title
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DCI COVID-19 Surveillance Project

Conditions
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Covid19

Intervention / Treatment
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* Diagnostic Test: SARS-CoV-2 RT-PCR Assay for Detection of COVID-19 Infection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who receive in-center chronic dialysis (>3 months) at DCI Henry Avenue Patients who are able to consent for study Exclusion Criteria: Patients receiving transient hemodialysis at DCI or receiving hemodialysis for Acute Renal Failure Patients who are unable to consent Patients who are receiving other forms of dialysis therapy (e.g. home hemodialysis, peritoneal dialysis) Patients whose life expectancy is <12 months Patients who are planning to leave the dialysis center within 12 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Cohort<br> | Diagnostic Test: SARS-CoV-2 RT-PCR Assay for Detection of COVID-19 Infection<br>* COVID-19 infection and antibody testing<br>* Other names: Beckman Coulter Access SARS-CoV-2 IgG Antibody Test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of COVID-19 infection in the cohort | COVID-19 infection assessed using the Hologic Aptima SARS-CoV-2 Assay and/or the Luminex NxTAG SARS-CoV-2 Extended Panel | monthly through study completion (average of 18 months) | 
| Link the presence of COVID-19 infection to COVID-19 antibody formation (seroconversion) from qualitative testing | Antibody formation assessed using the Beckman Coulter Access SARS-CoV-2 IgG Antibody Test | monthly through study completion (average of 18 months) | 
| Incidence of COVID-19 reinfection | COVID-19 infection assessed using the Hologic Aptima SARS-CoV-2 Assay and/or the Luminex NxTAG SARS-CoV-2 Extended Panel | monthly through study completion (average of 18 months) | 
| Presence of antibodies in cases of reinfection | Antibody formation assessed using the Beckman Coulter Access SARS-CoV-2 IgG Antibody Test | monthly through study completion (average of 18 months) |