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| ID | Type | Description | Link |
|---|---|---|---|
| X01DE030407 | Other Identifier | NIDCR |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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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.
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)..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testing for SARS CoV2 Antigen and Antibody | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Day 28 |
| DHCW Test Completion | Percentage of DHCWs with completed SARS-CoV-2 test completed | 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 | Day 28 |
| Number of DHCW With Complete Surveys | Number of participants with complete Start-of-study, Triage and End-of-Study surveys | Through study completion (3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 28 days |
| Positive Antibody Testing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cecile A Feldman, DMD, MBA | Rutgers School of Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers School of Dental Medicine | Newark | New Jersey | 07103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 33071007 | Background | 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. | |
| 34176567 |
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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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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. Study participation ranged from January- February 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Antigen and antibody to the virus as described. Testing for SARS CoV2 Antigen and Antibody: Antigen testing: Rapid Antigen testing (Point-of-care) Antibody testing: ELISA testing of microsampling 'finger-prick' specimen DHCW Survey for the adoption of risk mitigation practices and for perceptions of safety |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Antigen and antibody to the virus as described. Testing for SARS CoV2 Antigen and Antibody: Antigen testing: Rapid Antigen testing (Point-of-care) Antibody testing: ELISA testing of microsampling 'finger-prick' specimen DHCW Survey for the adoption of risk mitigation practices and for perceptions of safety |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Day 1 |
|
1 month
This study only involved a nasal swab, a finger-prick and survey.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Antigen and antibody to the virus as described. Testing for SARS CoV2 Antigen and Antibody: Antigen testing: Rapid Antigen testing (Point-of-care) Antibody testing: ELISA testing of microsampling 'finger-prick' specimen DHCW Survey for the adoption of risk mitigation practices and for perceptions of safety |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gayathri Subramanian, PhD, DMD | Rutgers School of Dental Medicine, Newark, New Jersey, United States | 7328247241 | subramga@sdm.rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 11, 2021 | Dec 11, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 19, 2021 | Dec 9, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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).
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Number of participants who tested positive for antibody to SARS-CoV2
| 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 | 28 days |
| Background |
| Shirazi 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | 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 | Posted | Count of Participants | Participants | Day 28 |
|
|
|
| Primary | DHCW Test Completion | Percentage of DHCWs with completed SARS-CoV-2 test completed | Posted | Count of Participants | Participants | Day 28 |
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | Day 28 |
|
|
|
| Primary | Number of DHCW With Complete Surveys | Number of participants with complete Start-of-study, Triage and End-of-Study surveys | Posted | Count of Participants | Participants | Through study completion (3 months) |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 28 days |
|
|
|
| Secondary | Positive Antibody Testing | Number of participants who tested positive for antibody to SARS-CoV2 | Posted | Count of Participants | Participants | 28 days |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 28 days |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |