DCI COVID-19 Surveillance Project

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 Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: SARS-CoV-2 RT-PCR Assay for Detection of COVID-19 Infection

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19129
      • Dialysis Clinic, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Temple University
• Collaborators: Dialysis Clinic, Inc.
• Investigators: Principal Investigator: Avrum Gillespie, MD, Temple University

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2021
• Primary Completion (Actual): October 13, 2022
• Study Completion (Actual): October 13, 2022

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Immunoglobulin G
• Other Study ID Numbers: 27042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No