Trial Outcomes & Findings for Rutgers Pilot for PREDICT- Patient LAB Test (NCT NCT05607043)

Results Overview

Percentage of 36 patients who were approached to enroll in the study who actually enrolled

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

Day 1

Results posted on

2023-09-22

Participant Flow

11 asymptomatic dental patients with upcoming appointments at the Oral Medicine clinic, Rutgers School of Dental Medicine, 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 infection as described. Testing for SARS CoV2 RNA: Device: Testing for SARS CoV2 RNA- lab-based RNA RT-PCR testing
Overall Study STARTED	11
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	2

Reasons for withdrawal

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 infection as described. Testing for SARS CoV2 RNA: Device: Testing for SARS CoV2 RNA- lab-based RNA RT-PCR testing
Overall Study Lost to Follow-up	2

Baseline Characteristics

Rutgers Pilot for PREDICT- Patient LAB Test

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SARS-CoV-2 Testing n=11 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 infection as described. Testing for SARS CoV2 RNA: Device: Testing for SARS CoV2 RNA- lab-based RNA RT-PCR testing
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	55.9 years STANDARD_DEVIATION 7.651 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	9 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: 36 patients were approached to enroll in the study. The percentage of 36 patients who consented to participate in the study is tabulated

Percentage of 36 patients who were approached to enroll in the study who actually enrolled

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Testing n=36 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 infection as described. Testing for SARS CoV2 RNA: Device: Testing for SARS CoV2 RNA- lab-based RNA RT-PCR testing
Patient Willingness to Participate in the Study	30 percentage

PRIMARY outcome

Timeframe: 26 days

Percentage of patients who complete the study

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Testing n=11 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 infection as described. Testing for SARS CoV2 RNA: Device: Testing for SARS CoV2 RNA- lab-based RNA RT-PCR testing
Willingness/Ability to Follow Through With the Study With Surveys, Triage and Testing	9 Participants

PRIMARY outcome

Timeframe: Day 1

Percentage of patients with completed SARS-CoV-2 testing

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Testing n=11 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 infection as described. Testing for SARS CoV2 RNA: Device: Testing for SARS CoV2 RNA- lab-based RNA RT-PCR testing
Patient Test Completion	10 Participants

PRIMARY outcome

Timeframe: From initial consent through study completion- approximately 4 weeks

Percentage of subjects completing study activities within the defined optimal window

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Testing n=11 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 infection as described. Testing for SARS CoV2 RNA: Device: Testing for SARS CoV2 RNA- lab-based RNA RT-PCR testing
Percentage of Subjects Who Complete Study Activities to Optimize Gap Between Testing and Study Visit	9 participants

PRIMARY outcome

Timeframe: Day 26

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

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Testing n=11 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 infection as described. Testing for SARS CoV2 RNA: Device: Testing for SARS CoV2 RNA- lab-based RNA RT-PCR testing
Ease of Complying With Protocol	8 Participants

PRIMARY outcome

Timeframe: 1 week

Percentage of patients participating in the study who completed pre-visit, triage and post-visit surveys

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Testing n=11 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 infection as described. Testing for SARS CoV2 RNA: Device: Testing for SARS CoV2 RNA- lab-based RNA RT-PCR testing
Percent of Patients Who Completed All of the Required Surveys	9 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: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place