Trial Outcomes & Findings for Clinical Validation of New Injection Molded Flocked Nasopharyngeal Swabs in Response to the COVID-19 Pandemic (NCT NCT04368260)

NCT ID: NCT04368260

Last Updated: 2022-02-17

Results Overview

Both the prototype and control nasopharyngeal swabs will be utilized in each subject. The rate of agreement between the swabs will be determined by the number of subjects for which both swabs provide the same COVID-19 PCR result.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: at time of enrollment
• Results posted on: 2022-02-17

Participant Flow

Participant milestones

Measure	All Study Participants 40 subjects with either presumed positive COVID-19 status or presumed negative COVID-19 status were included in this study. Control and prototype nasopharyngeal swabs were collected from each subject.
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	All Study Participants n=40 Participants 40 subjects with either presumed positive COVID-19 status or presumed negative COVID-19 status were included in this study. Control and prototype nasopharyngeal swabs were collected from each subject.
Age, Categorical <=18 years	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=40 Participants
Age, Categorical >=65 years	9 Participants n=40 Participants
Sex: Female, Male Female	20 Participants n=40 Participants
Sex: Female, Male Male	20 Participants n=40 Participants
Region of Enrollment United States	40 participants n=40 Participants
Presumed COVID-19 Status Presumed COVID-19 Positive	20 Participants n=40 Participants
Presumed COVID-19 Status Presumed COVID-19 Negative	20 Participants n=40 Participants

PRIMARY outcome

Timeframe: at time of enrollment

Both the prototype and control nasopharyngeal swabs will be utilized in each subject. The rate of agreement between the swabs will be determined by the number of subjects for which both swabs provide the same COVID-19 PCR result.

Outcome measures

Measure	Control Swab n=40 Participants FDA cleared swab Control swab: FDA-cleared nasopharyngeal swab	Prototype Swab n=40 Participants Injection molded polypropylene flocked nylon NP swab Prototype swab: Injection molded polypropylene flocked nylon nasopharyngeal swab
Number of Subjects for Which the Prototype Swab and the Control Swab Provide the Same COVID-19 PCR Result Positive Sample	18 participants	17 participants
Number of Subjects for Which the Prototype Swab and the Control Swab Provide the Same COVID-19 PCR Result Negative Sample	22 participants	23 participants

Adverse Events

Control Swab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Prototype Swab

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

Dr. Amy Mathers

University of Virginia

Phone: 434-924-9678

Email: ajm5b@virginia.edu

Results disclosure agreements

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