DCI COVID-19 Surveillance Project

Covid19 Clinical Trial

Official title:

DCI COVID-19 Surveillance Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04780698
• Other study ID #: 27042
• Status: Completed
• Phase: N/A
• Start date: February 12, 2021
• Est. completion date: October 13, 2022

Study information

• Verified date: February 2023
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 13, 2022
• Est. primary completion date: October 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Diagnostic Test:
• SARS-CoV-2 RT-PCR Assay for Detection of COVID-19 Infection
COVID-19 infection and antibody testing

Locations

Country	Name	City	State
United States	Dialysis Clinic, Inc.	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	Dialysis Clinic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)