Back to resultsDCI COVID-19 Surveillance Project
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SARS-CoV-2 RT-PCR Assay for Detection of COVID-19 Infection
Sponsored by
About this trial
This is an interventional screening trial for Covid19
Eligibility Criteria
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
Sites / Locations
- Dialysis Clinic, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Cohort
Arm Description
Outcomes
Primary Outcome Measures
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
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
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
Presence of antibodies in cases of reinfection
Antibody formation assessed using the Beckman Coulter Access SARS-CoV-2 IgG Antibody Test
Secondary Outcome Measures
Full Information
NCT ID
NCT04780698
First Posted
February 12, 2021
Last Updated
February 15, 2023
Sponsor
Temple University
Collaborators
Dialysis Clinic, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04780698
Brief Title
DCI COVID-19 Surveillance Project
Official Title
DCI COVID-19 Surveillance Project
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 12, 2021 (Actual)
Primary Completion Date
October 13, 2022 (Actual)
Study Completion Date
October 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
Dialysis Clinic, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Cohort
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
SARS-CoV-2 RT-PCR Assay for Detection of COVID-19 Infection
Other Intervention Name(s)
Beckman Coulter Access SARS-CoV-2 IgG Antibody Test
Intervention Description
COVID-19 infection and antibody testing
Primary Outcome Measure Information:
Title
Incidence of COVID-19 infection in the cohort
Description
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)
Title
Link the presence of COVID-19 infection to COVID-19 antibody formation (seroconversion) from qualitative testing
Description
Antibody formation assessed using the Beckman Coulter Access SARS-CoV-2 IgG Antibody Test
Time Frame
monthly through study completion (average of 18 months)
Title
Incidence of COVID-19 reinfection
Description
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)
Title
Presence of antibodies in cases of reinfection
Description
Antibody formation assessed using the Beckman Coulter Access SARS-CoV-2 IgG Antibody Test
Time Frame
monthly through study completion (average of 18 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avrum Gillespie, MD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dialysis Clinic, Inc.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19129
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
DCI COVID-19 Surveillance Project
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