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Completed

NCT Number: NCT04780698

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dialysis Clinic, Inc.

Philadelphia, Pennsylvania, 19129, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Diagnostic Test

COVID-19 infection and antibody testing

Other names: Beckman Coulter Access SARS-CoV-2 IgG Antibody Test

Primary outcomes

  1. Incidence of COVID-19 infection in the cohort

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: monthly through study completion (average of 18 months)

    Antibody formation assessed using the Beckman Coulter Access SARS-CoV-2 IgG Antibody Test

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • Dialysis Clinic, Inc.

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2021
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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