SARS-CoV2 InfectionPREDICT-DHCWNCT05607147
Rutgers Pilot for Dental Health Care Worker SARS-CoV-2 Testing
A study testing Testing for SARS CoV2 Antigen and Antibody in people with SARS-CoV2 Infection, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
10 asymptomatic DHCWs in 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 DHCWs' perceptions of safety and adoption of risk mitigation behavior. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV2 Infection
- What is being tested?
- Testing for SARS CoV2 Antigen and Antibody
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2021to 11 Feb 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dental healthcare workers (DHCW)s employed at Rutgers School of Dental Medicine
Who cannot join
- Previous participation
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)- Dental Health Care Workers
10 asymptomatic DHCWs in 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 DHCWs' perceptions of safety and adoption of risk mitigation behavior. Following a baseline survey, finger-prick blood samples were collected twice two weeks apart using an innovative microsampling technique that replaces the need for venipuncture. Samples were processed using an in-house ELISA assay to detect IgM and IgG directed against the Receptor Binding Domain (RBD) of the Spike protein. Weekly Rapid Antigen testing of nasal swab specimens was used to document Antigen negativity during the study.
Read the detailed description
10 asymptomatic DHCWs in the Oral Medicine clinic, Rutgers School of Dental Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled in the DHCW arm of the study. The DCHWs underwent triage that included self-reported symptoms, temperature check and obtaining a pulse oximeter reading at every study time-point (See DHCW Arm in Results Section). Weekly Rapid Antigen testing of nasal swab specimens was used to document Antigen negativity during the study (BD Veritor Plus Analyzer, BD Sciences). The DHCWs' perceptions of safety and adoption of risk mitigation behavior were interrogated. Following a baseline survey, finger-prick blood samples were collected twice two weeks apart using avolumentric absorptive microsampling with a Neoteryx Mitra cartridge device (https://www.neoteryx.com) device that allows for self-sampling by non-specialized personnel (https://doi.org/10.1101/2021.07.09.21260266). Briefly, this microsampler allows for volumentric absorption of 10-30 μl of blood depending on selected size. Following the collection, microsamplers were dried and kept within the protective cassettes at room temperature for maximum period of 2 weeks from the collection date. Each microsampler tip (20µl in the present study) was added to 200 μl VAMS extraction buffer (1x PBS (Corning) supplemented with 1% bovine serum albumin (Roche Diagnostics, Mannheim, Germany) and 0.5% Tween20 (Sigma, MO, USA) in a 1 ml deep-well 96 well plate (Greiner bio-one-780261). The plate was then covered with an adhesive seal and incubated 16 hours at 40C on a shaker at 250 rpm. The resulting eluates were heat inactivated at 560C for 60 minutes and centrifugation to collect the supernatant (eluate). Eluates were further processed for an in-house ELISA assay to detect IgM and IgG directed against the Receptor Binding Domain (RBD) of the SARS-CoV-2 Spike protein as described (https://doi.org/10.1101/2021.07.09.21260266)..
- Conditions
- SARS-CoV2 Infection
- Being tested
- Testing for SARS CoV2 Antigen and Antibody
- Keywords
- Dental Healthcare Worker, Testing, Seroprevalence, Perception of Safety, Adoption of risk mitigation practice
- 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 Antigen and AntibodyDevice
Antigen testing: Rapid Antigen testing (Point-of-care) Antibody testing: ELISA testing of microsampling 'finger-prick' specimen DHCW Survey for adoption of risk mitigation practices and for perceptions of safety
| 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 and antibody to the virus as described. Receives: Device: Testing for SARS CoV2 Antigen and Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Health Care Worker (DHCW) Willingness to Participate in the Study
Number of Dental Health Care Workers (DHCWs) approached to enroll 10 consenting subjects to participate in the study
Measured: Day 1
DHCW Willingness/Ability to Follow Through With the Study Surveys, Triage and Testing
Percentage of Dental Healthcare workers (DHCW)s who complete the study steps of surveys, triage and testing
Measured: Day 28
DHCW Test Completion
Percentage of DHCWs with completed SARS-CoV-2 test completed
Measured: Day 28
DHCW Ease of Complying With Protocol
Number of DHCWs who reported ease of complying with protocol as their choices on questions on the survey enquiring ease at start-of-study, end-of-study
Measured: Day 28
Number of DHCW With Complete Surveys
Number of participants with complete Start-of-study, Triage and End-of-Study surveys
Measured: Through study completion (3 months)
Secondary outcomes (3)
SARS CoV2 Rapid Antigen Testing (Point-of-care)- Number of Participants Who Tested Positive
Number of participants testing positive for SARS CoV2 using a point-of-care Rapid Antigen Testing
Measured: 28 days
Positive Antibody Testing
Number of participants who tested positive for antibody to SARS-CoV2
Measured: 28 days
Number of DCHWs Who Reported Feeling Safe and Comfortable Reporting to Work
Percentage of dental healthcare workers who responded feeling safe and comfortable reporting to work in the survey presented in the pilot study
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start26 Jan 2021
- Primary completion11 Feb 2021
- Study completion11 Feb 2021
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-CoV2 InfectionStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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 dental healthcare workers for seropositivity and antigen positivity for SARS-CoV-2 (Rapid Antigen point-of-care testing).
- Masking
- None (open label)
- Enrolment
- 10 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, DMD, MBA, Principal investigator, Rutgers School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607147
- Sponsor's protocol ID
- Pro2020002896
- Other IDs
- X01DE030407
- Acronym
- PREDICT-DHCW
- Status last verified
- Aug 2023
- First submitted
- 31 Oct 2022
- Last updated
- 24 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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 24 Aug 2023. 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)- Dental Health Care Workers
- ClinicalTrials.gov ID
- NCT05607147
- Acronym / sponsor ID
- PREDICT-DHCW / Pro2020002896
- Conditions
- SARS-CoV2 Infection
- Keywords
- Dental Healthcare Worker, Testing, Seroprevalence, Perception of Safety, Adoption of risk mitigation practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 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
- 26 Jan 2021 (actual)
- Primary completion
- 11 Feb 2021 (actual)
- Study completion
- 11 Feb 2021 (actual)
- First posted
- 7 Nov 2022 (actual)
- Results
- Posted 20 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
10 asymptomatic DHCWs in 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 DHCWs' perceptions of safety and adoption of risk mitigation behavior. Following a baseline survey, finger-prick blood samples were collected twice two weeks apart using an innovative microsampling technique that replaces the need for venipuncture. Samples were processed using an in-house ELISA assay to detect IgM and IgG directed against the Receptor Binding Domain (RBD) of the Spike protein. Weekly Rapid Antigen testing of nasal swab specimens was used to document Antigen negativity during the study.
Detailed description
10 asymptomatic DHCWs in the Oral Medicine clinic, Rutgers School of Dental Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled in the DHCW arm of the study. The DCHWs underwent triage that included self-reported symptoms, temperature check and obtaining a pulse oximeter reading at every study time-point (See DHCW Arm in Results Section). Weekly Rapid Antigen testing of nasal swab specimens was used to document Antigen negativity during the study (BD Veritor Plus Analyzer, BD Sciences). The DHCWs' perceptions of safety and adoption of risk mitigation behavior were interrogated. Following a baseline survey, finger-prick blood samples were collected twice two weeks apart using avolumentric absorptive microsampling with a Neoteryx Mitra cartridge device (https://www.neoteryx.com) device that allows for self-sampling by non-specialized personnel (https://doi.org/10.1101/2021.07.09.21260266). Briefly, this microsampler allows for volumentric absorption of 10-30 μl of blood depending on selected size. Following the collection, microsamplers were dried and kept within the protective cassettes at room temperature for maximum period of 2 weeks from the collection date. Each microsampler tip (20µl in the present study) was added to 200 μl VAMS extraction buffer (1x PBS (Corning) supplemented with 1% bovine serum albumin (Roche Diagnostics, Mannheim, Germany) and 0.5% Tween20 (Sigma, MO, USA) in a 1 ml deep-well 96 well plate (Greiner bio-one-780261). The plate was then covered with an adhesive seal and incubated 16 hours at 40C on a shaker at 250 rpm. The resulting eluates were heat inactivated at 560C for 60 minutes and centrifugation to collect the supernatant (eluate). Eluates were further processed for an in-house ELISA assay to detect IgM and IgG directed against the Receptor Binding Domain (RBD) of the SARS-CoV-2 Spike protein as described (https://doi.org/10.1101/2021.07.09.21260266)..
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 dental healthcare workers for seropositivity and antigen positivity for SARS-CoV-2 (Rapid Antigen point-of-care testing).
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 testing | Other | Device: Testing for SARS CoV2 Antigen and AntibodyThere 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 and antibody to the virus as described. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dental healthcare workers (DHCW)s employed at Rutgers School of Dental Medicine
Key exclusion criteria (1 listed)
- Previous participation
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 Antigen and AntibodyAntigen testing: Rapid Antigen testing (Point-of-care) Antibody testing: ELISA testing of microsampling 'finger-prick' specimen DHCW Survey for adoption of risk mitigation practices and for perceptions of safety | Device | SARS-CoV-2 testing |
Primary outcome
Dental Health Care Worker (DHCW) Willingness to Participate in the Study
Time frame: Day 1
Number of Dental Health Care Workers (DHCWs) approached to enroll 10 consenting subjects to participate in the study
DHCW Willingness/Ability to Follow Through With the Study Surveys, Triage and Testing
Time frame: Day 28
Percentage of Dental Healthcare workers (DHCW)s who complete the study steps of surveys, triage and testing
DHCW Test Completion
Time frame: Day 28
Percentage of DHCWs with completed SARS-CoV-2 test completed
DHCW Ease of Complying With Protocol
Time frame: Day 28
Number of DHCWs who reported ease of complying with protocol as their choices on questions on the survey enquiring ease at start-of-study, end-of-study
Number of DHCW With Complete Surveys
Time frame: Through study completion (3 months)
Number of participants with complete Start-of-study, Triage and End-of-Study surveys
3 secondary outcomes
SARS CoV2 Rapid Antigen Testing (Point-of-care)- Number of Participants Who Tested Positive
Time frame: 28 days
Positive Antibody Testing
Time frame: 28 days
Number of DCHWs Who Reported Feeling Safe and Comfortable Reporting to Work
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- 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. 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.
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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, DMD, MBA 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 and Antibody in people with SARS-CoV2 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 1 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 24 Aug 2023. 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 20 Mar 2023). 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?
Dental Health Care Worker (DHCW) Willingness to Participate in the Study (time frame: Day 1). The study lists 5 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 NCT05607147, 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 24 Aug 2023.