Trial Outcomes & Findings for Rutgers Pilot for Dental Health Care Worker SARS-CoV-2 Testing (NCT NCT05607147)

Results Overview

Number of Dental Health Care Workers (DHCWs) approached to enroll 10 consenting subjects to participate in the study

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Day 1

Results posted on

2023-08-24

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SARS-CoV-2 Testing n=10 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	39.9 years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Number of Dental Health Care Workers (DHCWs) approached to enroll 10 consenting subjects to participate in the study

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Testing n=10 Participants 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 adoption of risk mitigation practices and for perceptions of safety
Dental Health Care Worker (DHCW) Willingness to Participate in the Study	10 Participants

PRIMARY outcome

Timeframe: Day 28

Percentage of Dental Healthcare workers (DHCW)s who complete the study steps of surveys, triage and testing

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Testing n=10 Participants 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 adoption of risk mitigation practices and for perceptions of safety
DHCW Willingness/Ability to Follow Through With the Study Surveys, Triage and Testing	10 Participants

PRIMARY outcome

Timeframe: Day 28

Percentage of DHCWs with completed SARS-CoV-2 test completed

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Testing n=10 Participants 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 adoption of risk mitigation practices and for perceptions of safety
DHCW Test Completion	10 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Testing n=10 Participants 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 adoption of risk mitigation practices and for perceptions of safety
DHCW Ease of Complying With Protocol	9 Participants

PRIMARY outcome

Timeframe: Through study completion (3 months)

Number of participants with complete Start-of-study, Triage and End-of-Study surveys

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Testing n=10 Participants 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 adoption of risk mitigation practices and for perceptions of safety
Number of DHCW With Complete Surveys	10 Participants

SECONDARY outcome

Timeframe: 28 days

Number of participants testing positive for SARS CoV2 using a point-of-care Rapid Antigen Testing

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Testing n=10 Participants 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 adoption of risk mitigation practices and for perceptions of safety
SARS CoV2 Rapid Antigen Testing (Point-of-care)- Number of Participants Who Tested Positive	0 Participants

SECONDARY outcome

Timeframe: 28 days

Number of participants who tested positive for antibody to SARS-CoV2

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Testing n=10 Participants 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 adoption of risk mitigation practices and for perceptions of safety
Positive Antibody Testing	5 Participants

SECONDARY outcome

Timeframe: 28 days

Percentage of dental healthcare workers who responded feeling safe and comfortable reporting to work in the survey presented in the pilot study

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Testing n=10 Participants 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 adoption of risk mitigation practices and for perceptions of safety
Number of DCHWs Who Reported Feeling Safe and Comfortable Reporting to Work	10 Participants

Adverse Events

SARS-CoV-2 Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gayathri Subramanian, PhD, DMD

Rutgers School of Dental Medicine, Newark, New Jersey, United States

Phone: 7328247241

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place