Rutgers Pilot for PREDICT- Patient POC Test

• Sponsor: Rutgers, The State University of New Jersey (Other)
• Overall Status: Completed
• CT.gov ID: NCT05612724
• Collaborator: National Institute of Dental and Craniofacial Research (NIDCR) (NIH)
• Enrollment: 14
• Location: 1
• Arm: 1
• Actual Duration (Months): 22
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SARS CoV 2 Infection	Device: Testing for SARS CoV2 Antigen	N/A

Detailed Description

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 on their appointments, the remaining 4 patients did not present for their appointment.

Following initial interest in participation over the phone, the subjects completed a pre-visit survey prior to their upcoming appointment. The day prior to their visit, a phone triage was completed and repeated as they checked in for their appointment. A nasal sample was collected and processed using the FDA EUA authorized Rapid Antigen Test BD Veritor Plus Analyzer, BD Sciences. An end-of-study survey was collected to assess patients' feedback about their experience and their perception of safety.

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Pilot study to assess feasibility of testing asymptomatic dental patients for SARS-CoV-2 antigen using Rapid Antigen point-of-care testingPilot study to assess feasibility of testing asymptomatic dental patients for SARS-CoV-2 antigen using Rapid Antigen point-of-care testing
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Rutgers Pilot for Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT)- Patient POC Test
• Actual Study Start Date: Dec 30, 2020
• Actual Primary Completion Date: Oct 31, 2022
• Actual Study Completion Date: Oct 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: SARS-CoV-2 testing 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; Device: Testing for SARS CoV2 Antigen Antigen testing: Rapid Antigen testing (Point-of-care)

Outcome Measures

Primary Outcome Measures

1. Patient willingness to follow through with the study surveys, triage and testing [Day 1]

   Percentage of patients who complete the study

2. Patient test completion [Day 1]

   Percentage of patients with completed SARS-CoV-2 testing

3. Patient ease of complying with protocol [Day 1]

   Questions on survey on how easy it was to complete pre-visit and post-visit formalities

4. Percentage of surveys completed by patients [Through study completion (3 months)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• Patients previously participating in the study

• Patients unwilling to have their de-identified data made available to researchers

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rutgers School of Dental Medicine	Newark	New Jersey	United States	07103

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Cecile A Feldman, Rutgers School of Dental Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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. Erratum In: J Am Dent Assoc. 2021 Sep;152(9):719.

• Responsible Party: Cecile A. Feldman, DMD, Professor, Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT05612724
• Other Study ID Numbers: Pro2020002998; X01DE030407
• First Posted: Nov 10, 2022
• Last Update Posted: Nov 10, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Cecile A. Feldman, DMD, Professor, Rutgers, The State University of New Jersey: Screening; Point-of-care testing; Asymptomatic patients; Perception of safety; Feasibility
• Additional relevant MeSH terms: Infections; COVID-19

Study Results

No Results Posted as of Nov 10, 2022