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DCI COVID-19 Surveillance Project

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ClinicalTrials.gov Identifier: NCT04780698
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Collaborator:
Dialysis Clinic, Inc.
Information provided by (Responsible Party):
Temple University

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
Covid19 Diagnostic Test: SARS-CoV-2 RT-PCR Assay for Detection of COVID-19 Infection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: DCI COVID-19 Surveillance Project
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : March 2022

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
  • Mount Sinai COVID-19 ELISA IgG Antibody Test




Primary Outcome Measures :
  1. Incidence of COVID-19 infection in the cohort [ Time Frame: monthly through study completion (average of 6 months) ]
  2. Link the presence of COVID-19 infection to COVID-19 antibody formation (seroconversion) from quantitative and qualitative testing [ Time Frame: monthly through study completion (average of 6 months) ]
  3. Incidence of COVID-19 reinfection [ Time Frame: monthly through study completion (average of 6 months) ]
  4. Presence of antibodies in cases of reinfection [ Time Frame: monthly through study completion (average of 6 months) ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780698


Contacts
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Contact: Sally B Quinn, RN, MSN 215-707-7576 Sally.Quinn@tuhs.temple.edu
Contact: Jean Lee, MD 215-707-0744 jean.lee@tuhs.temple.edu

Locations
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United States, Pennsylvania
Dialysis Clinic, Inc. Recruiting
Philadelphia, Pennsylvania, United States, 19129
Sponsors and Collaborators
Temple University
Dialysis Clinic, Inc.
Investigators
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Principal Investigator: Crystal A Gadegbeku, MD Temple University
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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT04780698    
Other Study ID Numbers: 27042
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Antibodies
Immunoglobulins
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs