SARS CoV 2 InfectionNCT05612724
Rutgers Pilot for PREDICT- Patient POC Test
A study testing Testing for SARS CoV2 Antigen in people with SARS CoV 2 Infection, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS CoV 2 Infection
- What is being tested?
- Testing for SARS CoV2 Antigen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2020to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dental Patients with upcoming appointment at the Oral Medicine Clinic at Rutgers School of Dental Medicine
Who cannot join
- Patients previously participating in the study
- Patients unwilling to have their de-identified data made available to researchers
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers School of Dental Medicine
Newark, New Jersey, 07103
About this study
Official title: Rutgers Pilot for Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT)- Patient POC Test
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.
Read the detailed description
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 on their appointments, the remaining 4 patients did not present for their appointment.
Following initial interest in participation over the phone, the subjects completed a pre-visit survey prior to their upcoming appointment. The day prior to their visit, a phone triage was completed and repeated as they checked in for their appointment. A nasal sample was collected and processed using the FDA EUA authorized Rapid Antigen Test BD Veritor Plus Analyzer, BD Sciences. An end-of-study survey was collected to assess patients' feedback about their experience and their perception of safety.
- Conditions
- SARS CoV 2 Infection
- Being tested
- Testing for SARS CoV2 Antigen
- Keywords
- Screening, Point-of-care testing, Asymptomatic patients, Perception of safety, Feasibility
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing for SARS CoV2 AntigenDevice
Device: Testing for SARS CoV2 Antigen Antigen testing: Rapid Antigen testing (Point-of-care)
| Study group | Role | What they receive |
|---|---|---|
| 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 Antigen as described. Receives: Device: Testing for SARS CoV2 Antigen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Willingness to Follow Through With the Study Surveys, Triage and Testing
Percentage of 14 patients who complete the study
Measured: Through study completion, an average of 21 days
Patient Test Completion
Percentage of 14 patients with completed SARS-CoV-2 testing
Measured: Day 1
Patient Ease of Complying With Protocol
Number of participants indicating that it was easy to complete the surveys
Measured: Day 21
Percentage of Surveys Completed by Patients
Percentage of patients with completed pre-visit, triage and post-visit surveys completed
Measured: Through study completion (21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start30 Dec 2020
- Primary completion20 Jan 2021
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SARS CoV 2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study to assess feasibility of testing asymptomatic dental patients for SARS-CoV-2 antigen using Rapid Antigen point-of-care testing
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Cecile A. Feldman, DMD, Rutgers, The State University of New Jersey
- Investigators
- Cecile A Feldman, Principal investigator, Rutgers School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612724
- Sponsor's protocol ID
- Pro2020002998
- Other IDs
- X01DE030407
- Status last verified
- Mar 2024
- First submitted
- 31 Oct 2022
- Last updated
- 27 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: D: 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.
Publications
1. 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.
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.
PubMed 33071007Shirazi 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.
PubMed 34176567
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rutgers Pilot for Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT)- Patient POC Test
- ClinicalTrials.gov ID
- NCT05612724
- Acronym / sponsor ID
- Pro2020002998
- Conditions
- SARS CoV 2 Infection
- Keywords
- Screening, Point-of-care testing, Asymptomatic patients, Perception of safety, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 10 Nov 2022 (actual)
- Results
- Posted 27 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 on their appointments, the remaining 4 patients did not present for their appointment.
Following initial interest in participation over the phone, the subjects completed a pre-visit survey prior to their upcoming appointment. The day prior to their visit, a phone triage was completed and repeated as they checked in for their appointment. A nasal sample was collected and processed using the FDA EUA authorized Rapid Antigen Test BD Veritor Plus Analyzer, BD Sciences. An end-of-study survey was collected to assess patients' feedback about their experience and their perception of safety.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study to assess feasibility of testing asymptomatic dental patients for SARS-CoV-2 antigen using Rapid Antigen point-of-care testing
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 testing | Other | Device: Testing for SARS CoV2 AntigenThere 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 Antigen as described. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dental Patients with upcoming appointment at the Oral Medicine Clinic at Rutgers School of Dental Medicine
Key exclusion criteria (2 listed)
- Patients previously participating in the study
- Patients unwilling to have their de-identified data made available to researchers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testing for SARS CoV2 AntigenDevice: Testing for SARS CoV2 Antigen Antigen testing: Rapid Antigen testing (Point-of-care) | Device | SARS-CoV-2 testing |
Primary outcome
Patient Willingness to Follow Through With the Study Surveys, Triage and Testing
Time frame: Through study completion, an average of 21 days
Percentage of 14 patients who complete the study
Patient Test Completion
Time frame: Day 1
Percentage of 14 patients with completed SARS-CoV-2 testing
Patient Ease of Complying With Protocol
Time frame: Day 21
Number of participants indicating that it was easy to complete the surveys
Percentage of Surveys Completed by Patients
Time frame: Through study completion (21 days)
Percentage of patients with completed pre-visit, triage and post-visit surveys completed
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background1. 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: PubMed 33071007Estrich 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.
- Background: PubMed 34176567Shirazi 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.
- Individual participant dataSharing planned: No. D: 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.
Related trials for SARS CoV 2 Infection
RecruitingPhase 2
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age
SARS-CoV-2
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Recruiting
RSV Burden in Outpatient and Hospital Settings
RSV Infection, Children, Only
Active, not recruitingObservational study
Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)
COVID-19 Vaccination
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecile A Feldman principal investigator
Rutgers School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Testing for SARS CoV2 Antigen in people with SARS CoV 2 Infection, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Willingness to Follow Through With the Study Surveys, Triage and Testing (time frame: Through study completion, an average of 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05612724, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.