Rutgers Pilot for PREDICT- Patient LAB Test

NCT05607043 | Completed Results FDA Device

• 2 other identifiers: Pro2020002999X01DE030407
• Study Type: interventional
• Target: 11
• 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 RNA using an FDA approved RT-PCR test for SARS-CoV2- an RNA RT-PCR assay (Accurate Diagnostics)

Conditions

SARS-CoV2 Infection

Keywords

Screening; Lab-based testing; Asymptomatic patients; Perception of safety; Feasibility

Outcome Measures

Primary Outcomes (6)

• Patient Willingness to Participate in the Study

  Percentage of 36 patients who were approached to enroll in the study who actually enrolled

  Day 1

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

  Percentage of patients who complete the study

  26 days

• Patient Test Completion

  Percentage of patients with completed SARS-CoV-2 testing

  Day 1

• Percentage of Subjects Who Complete Study Activities to Optimize Gap Between Testing and Study Visit

  Percentage of subjects completing study activities within the defined optimal window

  From initial consent through study completion- approximately 4 weeks

• Ease of Complying With Protocol

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

  Day 26

• Percent of Patients Who Completed All of the Required Surveys

  Percentage of patients participating in the study who completed pre-visit, triage and post-visit surveys

  1 week

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 infection as described.

Device: Testing for SARS CoV2 RNA

Interventions

Testing for SARS CoV2 RNA DEVICE

Device: Testing for SARS CoV2 RNA- lab-based RNA RT-PCR testing

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:

• Adult 18 years or older; reporting to the Rutgers School of Dental Medicine for a dental visit

You may not qualify if:

• Previous participation

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)

• 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 lab-based RNA RT-PCR testing

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 7, 2022
• Study Start: January 31, 2021
• Primary Completion: February 25, 2021
• Study Completion: February 25, 2021
• Last Updated: September 22, 2023
• Results First Posted: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)