Covid19
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTSARS-CoV-2 RT-PCR Assay for Detection of COVID-19 Infection
COVID-19 infection and antibody testing
Sponsors
Dialysis Clinic, Inc.
Temple University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of COVID-19 infection in the cohort | monthly through study completion (average of 18 months) | COVID-19 infection assessed using the Hologic Aptima SARS-CoV-2 Assay and/or the Luminex NxTAG SARS-CoV-2 Extended Panel |
| Link the presence of COVID-19 infection to COVID-19 antibody formation (seroconversion) from qualitative testing | monthly through study completion (average of 18 months) | Antibody formation assessed using the Beckman Coulter Access SARS-CoV-2 IgG Antibody Test |
| Incidence of COVID-19 reinfection | monthly through study completion (average of 18 months) | COVID-19 infection assessed using the Hologic Aptima SARS-CoV-2 Assay and/or the Luminex NxTAG SARS-CoV-2 Extended Panel |
| Presence of antibodies in cases of reinfection | monthly through study completion (average of 18 months) | Antibody formation assessed using the Beckman Coulter Access SARS-CoV-2 IgG Antibody Test |
Countries
United States
Outcome results
None listed