Trial Outcomes & Findings for Rutgers Pilot for PREDICT- Patient POC Test (NCT NCT05612724)

NCT ID: NCT05612724

Last Updated: 2024-03-27

Results Overview

Percentage of 14 patients who complete the study

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: Through study completion, an average of 21 days
• Results posted on: 2024-03-27

Participant Flow

14 asymptomatic dental patients with upcoming appointments at the Oral Medicine Clinic, Rutgers School of Dental Medicine, were enrolled. Study participation took place in between December 2020 and January 2021.

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 as described. Testing for SARS CoV2 Antigen: Device: Testing for SARS CoV2 Antigen Antigen testing: Rapid Antigen testing (Point-of-care)
Overall Study STARTED	14
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	4

Reasons for withdrawal

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 as described. Testing for SARS CoV2 Antigen: Device: Testing for SARS CoV2 Antigen Antigen testing: Rapid Antigen testing (Point-of-care)
Overall Study Lost to Follow-up	4

Baseline Characteristics

Rutgers Pilot for PREDICT- Patient POC Test

Baseline characteristics by cohort

Measure	SARS-CoV-2 Testing n=14 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 as described. Testing for SARS CoV2 Antigen: Device: Testing for SARS CoV2 Antigen Antigen testing: Rapid Antigen testing (Point-of-care)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	45.9 years STANDARD_DEVIATION 17.55 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	6 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 21 days

Population: 14 patients enrolled in the study. The percentage of 14 patients who completed the study is tabulated

Percentage of 14 patients who complete the study

Outcome measures

Measure	SARS-CoV-2 Testing n=14 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 as described. Testing for SARS CoV2 Antigen: Device: Testing for SARS CoV2 Antigen Antigen testing: Rapid Antigen testing (Point-of-care)
Patient Willingness to Follow Through With the Study Surveys, Triage and Testing	71.42 percentage of participants

PRIMARY outcome

Timeframe: Day 1

Percentage of 14 patients with completed SARS-CoV-2 testing

Outcome measures

Measure	SARS-CoV-2 Testing n=14 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 as described. Testing for SARS CoV2 Antigen: Device: Testing for SARS CoV2 Antigen Antigen testing: Rapid Antigen testing (Point-of-care)
Patient Test Completion	10 Participants

PRIMARY outcome

Timeframe: Day 21

Number of participants indicating that it was easy to complete the surveys

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 as described. Testing for SARS CoV2 Antigen: Device: Testing for SARS CoV2 Antigen Antigen testing: Rapid Antigen testing (Point-of-care)
Patient Ease of Complying With Protocol	10 Participants

PRIMARY outcome

Timeframe: Through study completion (21 days)

Percentage of patients with completed pre-visit, triage and post-visit surveys completed

Outcome measures

Measure	SARS-CoV-2 Testing n=14 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 as described. Testing for SARS CoV2 Antigen: Device: Testing for SARS CoV2 Antigen Antigen testing: Rapid Antigen testing (Point-of-care)
Percentage of Surveys Completed by Patients	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: 732 824 7241

Email: subramga@sdm.rutgers.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place