N/A
N=14
Rutgers Pilot for PREDICT- Patient POC Test
SARS CoV 2 Infection
Bottom Line
View on ClinicalTrials.gov: NCT05612724 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Patient Willingness to Follow Through With the Study Surveys, Triage and Testing — 71.42 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Testing for SARS CoV2 Antigen (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Willingness to Follow Through With the Study Surveys, Triage and Testing |
71.42 | — |
| PRIMARY Patient Test Completion |
10 | — |
| PRIMARY Patient Ease of Complying With Protocol |
10 | — |
| PRIMARY Percentage of Surveys Completed by Patients |
10 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05612724). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.