SARS-CoV2 Infection
Conditions
Keywords
Screening, Lab-based testing, Asymptomatic patients, Perception of safety, Feasibility
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.
Interventions
DEVICETesting for SARS CoV2 RNA
Device: Testing for SARS CoV2 RNA- lab-based RNA RT-PCR testing
Sponsors
National Institute of Dental and Craniofacial Research (NIDCR)
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Pilot study to assess feasibility of testing asymptomatic dental patients for SARS-CoV-2 antigen using lab-based RNA RT-PCR testing
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult 18 years or older; reporting to the Rutgers School of Dental Medicine for a dental visit
Exclusion criteria
* Previous participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Willingness to Participate in the Study | Day 1 | Percentage of 36 patients who were approached to enroll in the study who actually enrolled |
| Willingness/Ability to Follow Through With the Study With Surveys, Triage and Testing | 26 days | Percentage of patients who complete the study |
| 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 |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 infection as described.
Testing for SARS CoV2 RNA: Device: Testing for SARS CoV2 RNA- lab-based RNA RT-PCR testing | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | SARS-CoV-2 Testing |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 55.9 years STANDARD_DEVIATION 7.651 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Ease of Complying With Protocol
Number of participants indicating that it was easy to complete the surveys
Time frame: Day 26
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SARS-CoV-2 Testing | Ease of Complying With Protocol | 8 Participants |
Primary
Patient Test Completion
Percentage of patients with completed SARS-CoV-2 testing
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SARS-CoV-2 Testing | Patient Test Completion | 10 Participants |
Primary
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
Population: 36 patients were approached to enroll in the study. The percentage of 36 patients who consented to participate in the study is tabulated
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SARS-CoV-2 Testing | Patient Willingness to Participate in the Study | 30 percentage |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SARS-CoV-2 Testing | Percentage of Subjects Who Complete Study Activities to Optimize Gap Between Testing and Study Visit | 9 participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SARS-CoV-2 Testing | Percent of Patients Who Completed All of the Required Surveys | 9 Participants |
Primary
Willingness/Ability to Follow Through With the Study With Surveys, Triage and Testing
Percentage of patients who complete the study
Time frame: 26 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SARS-CoV-2 Testing | Willingness/Ability to Follow Through With the Study With Surveys, Triage and Testing | 9 Participants |