An interventional study of Testing for SARS CoV2 RNA in SARS-CoV2 Infection, sponsored by Rutgers, The State University of New Jersey. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-22.
Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Other
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)
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 11 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Device: Testing for SARS CoV2 RNA- lab-based RNA RT-PCR testing
Patient Willingness to Participate in the Study
Percentage of 36 patients who were approached to enroll in the study who actually enrolled
Time frame: Day 1
Willingness/Ability to Follow Through With the Study With Surveys, Triage and Testing
Percentage of patients who complete the study
Time frame: 26 days
Patient Test Completion
Percentage of patients with completed SARS-CoV-2 testing
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 week
11 asymptomatic dental patients with upcoming appointments at the Oral Medicine clinic, Rutgers School of Dental Medicine, were enrolled. Study participation ranged from January- February 2021.
| Milestone | SARS-CoV-2 Testing |
|---|---|
| Started | 11 |
| Completed | 9 |
| Not completed | 2 |
| Withdrew: Lost to follow-up | 2 |
Percentage of 36 patients who were approached to enroll in the study who actually enrolled
| percentage | SARS-CoV-2 Testing |
|---|---|
| Patient Willingness to Participate in the Study | 30 |
Percentage of patients who complete the study
| Participants | SARS-CoV-2 Testing |
|---|---|
| Willingness/Ability to Follow Through With the Study With Surveys, Triage and Testing | 9 |
Percentage of patients with completed SARS-CoV-2 testing
| Participants | SARS-CoV-2 Testing |
|---|---|
| Patient Test Completion | 10 |
Percentage of subjects completing study activities within the defined optimal window
| participants | SARS-CoV-2 Testing |
|---|---|
| Percentage of Subjects Who Complete Study Activities to Optimize Gap Between Testing and Study Visit | 9 |
Number of participants indicating that it was easy to complete the surveys
| Participants | SARS-CoV-2 Testing |
|---|---|
| Ease of Complying With Protocol | 8 |
Percentage of patients participating in the study who completed pre-visit, triage and post-visit surveys
| Participants | SARS-CoV-2 Testing |
|---|---|
| Percent of Patients Who Completed All of the Required Surveys | 9 |
Collected over From signing initial consent to completion of study visit- approximately 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SARS-CoV-2 Testing | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Categorical(Participants) | SARS-CoV-2 Testing |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 11 |
| >=65 years | 0 |
| Age, Continuous(years) | SARS-CoV-2 Testing |
|---|---|
| Mean | 55.9 ± 7.651 |
| Sex: Female, Male(Participants) | SARS-CoV-2 Testing |
|---|---|
| Female | 8 |
| Male | 3 |
| Race (NIH/OMB)(Participants) | SARS-CoV-2 Testing |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 9 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — If the COVID test results show that a participant is positive for COVID-19, the study staff will tell the participant the results. The study staff will be required to give the participant's name to the state's Department of Public Health if the participant tests positive because this is the law. At the end of the study, de-identified data will be provided to the National Coordinating Center.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Rutgers, The State University of New Jersey