Rutgers Pilot for Dental Health Care Worker SARS-CoV-2 Testing

SARS-CoV2 Infection Clinical Trial

— PREDICT-DHCW  

Official title:

Rutgers Pilot for Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT)- Dental Health Care Workers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05607147
• Other study ID #: Pro2020002896
• Secondary ID: X01DE030407
• Status: Completed
• Phase: N/A
• Start date: January 26, 2021
• Est. completion date: February 11, 2021

Study information

• Verified date: August 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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)..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 11, 2021
• Est. primary completion date: February 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Dental healthcare workers (DHCW)s employed at Rutgers School of Dental Medicine

Exclusion Criteria:

• Previous participation

Related Conditions & MeSH terms

• COVID-19
• Infections
• SARS-CoV2 Infection

Intervention

Device:
• 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 adoption of risk mitigation practices and for perceptions of safety

Locations

Country	Name	City	State
United States	Rutgers School of Dental Medicine	Newark	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. Erratum In: J Am Dent Assoc. 2021 Sep;152(9):719. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Day 1
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	Day 28
Primary	DHCW Test Completion	Percentage of DHCWs with completed SARS-CoV-2 test completed	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	Day 28
Primary	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)
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	28 days
Secondary	Positive Antibody Testing	Number of participants who tested positive for antibody to SARS-CoV2	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	28 days