NCT04780698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 12, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2022

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

February 12, 2021

Last Update Submit

February 15, 2023

Conditions

Covid19

Outcome Measures

Primary Outcomes (4)

  • 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)

Study Arms (1)

Study Cohort

EXPERIMENTAL
Diagnostic Test: SARS-CoV-2 RT-PCR Assay for Detection of COVID-19 Infection

Interventions

SARS-CoV-2 RT-PCR Assay for Detection of COVID-19 InfectionDIAGNOSTIC_TEST

COVID-19 infection and antibody testing

Also known as: Beckman Coulter Access SARS-CoV-2 IgG Antibody Test
Study Cohort

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who receive in-center chronic dialysis (\>3 months) at DCI Henry Avenue
  • Patients who are able to consent for study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dialysis Clinic, Inc.

Philadelphia, Pennsylvania, 19129, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Avrum Gillespie, MD

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2021

First Posted

March 3, 2021

Study Start

February 12, 2021

Primary Completion

October 13, 2022

Study Completion

October 13, 2022

Last Updated

February 16, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)