Rutgers Pilot for PREDICT- Patient LAB Test

Not Applicable

Completed

• Conditions: SARS-CoV2 Infection
• Interventions: Device: Testing for SARS CoV2 RNA

• Registration Number: NCT05607043
• Lead Sponsor: Rutgers, The State University of New Jersey

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)

Detailed Description

Patients with upcoming dental appointments at the Oral Medicine clinic at Rutgers School of Dental Medicine were contacted to solicit interest in participating in a pilot study to assess feasibility of testing asymptomatic dental patients for SARS CoV 2 infection using an RNA RT-PCR assay. Interested subjects completed a previsit survey after confirming their interest electronically. Subsequently, they received kit to collect their saliva sample at home along with instructions on how to do so. They were directed to drop off their saliva samples for testing at the dental clinic and signed the consent form at that time. After confirming a negative result, the patients were subsequently triaged over the phone for any symptoms and the following day, presented for their dental visit.

On the day of their visit, they were triaged, completed their dental visit and were surveyed to get their feedback on the study procedures and their perceptions of safety.

Study Timeline

• Study Start: 2021-01-31
• Primary Completion: 2021-02-25
• Study Completion: 2021-02-25
• Study First Submitted: 2022-10-31
• Study First Submitted QC: 2022-10-31
• Study First Posted: 2022-11-07
• Results First Submitted: 2023-07-13
• Results First Submitted QC: 2023-08-31
• Status Verified: 2023-09
• Results First Posted: 2023-09-13
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

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

Exclusion Criteria

• Previous participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SARS-CoV-2 testing	Testing for SARS CoV2 RNA	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.

Primary Outcome Measures

Name	Time	Method
Willingness/Ability to Follow Through With the Study With Surveys, Triage and Testing	26 days	Percentage of patients who complete the study
Patient Willingness to Participate in the Study	Day 1	Percentage of 36 patients who were approached to enroll in the study who actually enrolled
Patient Test Completion	Day 1	Percentage of patients with completed SARS-CoV-2 testing
Percentage of Subjects Who Complete Study Activities to Optimize Gap Between Testing and Study Visit	From initial consent through study completion- approximately 4 weeks	Percentage of subjects completing study activities within the defined optimal window
Ease of Complying With Protocol	Day 26	Number of participants indicating that it was easy to complete the surveys
Percent of Patients Who Completed All of the Required Surveys	1 week	Percentage of patients participating in the study who completed pre-visit, triage and post-visit surveys

Trial Locations

Locations (1)

Rutgers School of Dental Medicine; 🇺🇸 Newark, New Jersey, United States