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DCI COVID-19 Surveillance Project

Sponsor
Temple University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04780698
Collaborator
Dialysis Clinic, Inc. (Industry)
30
Enrollment
1
Location
1
Arm
21.6
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: SARS-CoV-2 RT-PCR Assay for Detection of COVID-19 Infection
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
DCI COVID-19 Surveillance Project
Actual Study Start Date :
Feb 12, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. 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

    4. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dialysis Clinic, Inc. Philadelphia Pennsylvania United States 19129

    Sponsors and Collaborators

    • Temple University
    • Dialysis Clinic, Inc.

    Investigators

    • Principal Investigator: Avrum Gillespie, MD, Temple University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Temple University
    ClinicalTrials.gov Identifier:
    NCT04780698
    Other Study ID Numbers:
    • 27042
    First Posted:
    Mar 3, 2021
    Last Update Posted:
    May 31, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Immunoglobulin G

    Study Results

    No Results Posted as of May 31, 2022