Rutgers Pilot for PREDICT- Patient POC Test

NCT05612724 | Completed Results FDA Device

• 2 other identifiers: Pro2020002998X01DE030407
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

A pilot study was initiated to assess feasibility of testing asymptomatic dental patients presenting to the Oral Medicine Clinic at Rutgers School of Dental Medicine for SARS-CoV-2 viral antigen using a point-of-care (POC) Rapid Antigen test. 14 subjects with upcoming appointment at the Oral Medicine clinic, Rutgers School of Dental Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled in a study that interrogated patients' perceptions of safety and feedback regarding their testing experience. All 14 patients expressed initial interest, however, 10 patients completed informed consent and completed study procedures. Institutional Clinical Laboratory Improvement Amendments (CLIA) certification of waiver was obtained prior to conducting the study. Communicable Diseases Reporting and Surveillance System (CDRSS) registration and training were completed to enable reporting results of the POC test.

Conditions

SARS CoV 2 Infection

Keywords

Screening; Point-of-care testing; Asymptomatic patients; Perception of safety; Feasibility

Outcome Measures

Primary Outcomes (4)

• Patient Willingness to Follow Through With the Study Surveys, Triage and Testing

  Percentage of 14 patients who complete the study

  Through study completion, an average of 21 days

• Patient Test Completion

  Percentage of 14 patients with completed SARS-CoV-2 testing

  Day 1

• Patient Ease of Complying With Protocol

  Number of participants indicating that it was easy to complete the surveys

  Day 21

• Percentage of Surveys Completed by Patients

  Percentage of patients with completed pre-visit, triage and post-visit surveys completed

  Through study completion (21 days)

Study Arms (1)

SARS-CoV-2 testing

OTHER

There is only one arm in this study- the study is a non-randomized pilot. All the subjects will be tested for SARS CoV 2 viral Antigen as described.

Device: Testing for SARS CoV2 Antigen

Interventions

Testing for SARS CoV2 Antigen DEVICE

Device: Testing for SARS CoV2 Antigen Antigen testing: Rapid Antigen testing (Point-of-care)

SARS-CoV-2 testing

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dental Patients with upcoming appointment at the Oral Medicine Clinic at Rutgers School of Dental Medicine

You may not qualify if:

• Patients previously participating in the study
• Patients unwilling to have their de-identified data made available to researchers

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Rutgers School of Dental Medicine

Newark, New Jersey, 07103, United States

Location

Related Publications (3)

• 1. American Dental Association COVID-19 Toolkit - Update to Office Procedures During COVID-19. https://www.ada.org/-/media/project/ada-organization/ada/ada-org/files/resources/coronavirus/update_to_office_procedures_during_covid19.pdf accessed on November 11, 2021.

  BACKGROUND

• Estrich CG, Mikkelsen M, Morrissey R, Geisinger ML, Ioannidou E, Vujicic M, Araujo MWB. Estimating COVID-19 prevalence and infection control practices among US dentists. J Am Dent Assoc. 2020 Nov;151(11):815-824. doi: 10.1016/j.adaj.2020.09.005.

  PMID: 33071007 BACKGROUND

• Shirazi S, Stanford CM, Cooper LF. Testing for COVID-19 in dental offices: Mechanism of action, application, and interpretation of laboratory and point-of-care screening tests. J Am Dent Assoc. 2021 Jul;152(7):514-525.e8. doi: 10.1016/j.adaj.2021.04.019. Epub 2021 May 4.

  PMID: 34176567 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Gayathri Subramanian, PhD, DMD
• Organization: Rutgers School of Dental Medicine, Newark, New Jersey, United States

subramga@sdm.rutgers.edu

732 824 7241

Study Officials

• Cecile A Feldman

  Rutgers School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Pilot study to assess feasibility of testing asymptomatic dental patients for SARS-CoV-2 antigen using Rapid Antigen point-of-care testing

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 10, 2022
• Study Start: December 30, 2020
• Primary Completion: January 20, 2021
• Study Completion: October 31, 2022
• Last Updated: March 27, 2024
• Results First Posted: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)