DCI COVID-19 Surveillance Project

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Diagnostic Test: SARS-CoV-2 RT-PCR Assay for Detection of COVID-19 Infection

• Registration Number: NCT04780698
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-12
• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-03
• Primary Completion: 2022-10-13
• Study Completion: 2022-10-13
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Cohort	SARS-CoV-2 RT-PCR Assay for Detection of COVID-19 Infection	-

Primary Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

Dialysis Clinic, Inc.; 🇺🇸 Philadelphia, Pennsylvania, United States