DCI COVID-19 Surveillance Project

Temple University30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Covid19

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: monthly through study completion (average of 18 months)

DCI COVID-19 Surveillance Project

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes