COVID-19 Testing Pilot Study

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT04843878

Collaborator

Benjamin S. Abella, MD, MPhil (Other), Marcelo Der Torossian Torres, Ph.D. (Other), Cesar De La Fuente, Ph.D. (Other)

326

Enrollment

Location

2.2

Actual Duration (Months)

150.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the reliability of a low-cost rapid diagnostic test for COVID-19. The method of the testing procedure uses electrochemistry to detect COVID-19 spike proteins within human samples. To test the effectiveness of this new method, patients will be recruited as they present for testing at ambulatory Penn testing sites. Patients will be asked to self-collect one anterior nares samples under the supervision of authorized study personnel.

Condition or Disease	Intervention/Treatment	Phase
Diagnostic Test, Routine Coronavirus Diagnoses Disease Rapid Coronavirus Test	Diagnostic Test: COVID Detect

Study Design

Study Type:

Observational

Actual Enrollment :

326 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Feasibility Testing of a New COVID-19 Testing Platform

Actual Study Start Date :

Jan 5, 2021

Actual Primary Completion Date :

Mar 12, 2021

Actual Study Completion Date :

Mar 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
Positive Subjects that tested positive for COVID-19 based on the clinical gold standard PCR test.	Diagnostic Test: COVID Detect The study is determining the efficacy of a new rapid COVID testing method.
Negative Subjects that tested negative for COVID-19 based on the clinical gold standard PCR test.	Diagnostic Test: COVID Detect The study is determining the efficacy of a new rapid COVID testing method.

Arm

Intervention/Treatment

Positive

Subjects that tested positive for COVID-19 based on the clinical gold standard PCR test.

Diagnostic Test: COVID Detect

The study is determining the efficacy of a new rapid COVID testing method.

Negative

Subjects that tested negative for COVID-19 based on the clinical gold standard PCR test.

Diagnostic Test: COVID Detect

The study is determining the efficacy of a new rapid COVID testing method.

Outcome Measures

Primary Outcome Measures

Device Accuracy - Positive and Negative Percentage [3 Months]
The accuracy of the new prototype testing method will be determined by comparing the prototype's result to the clinical gold standard PCR test. The accuracy will be determined by calculating the percentage of the test's ability to correctly identify both the presence and absence of virus compared to the PCR result for the positive and negative results.
Device Accuracy - False positive and False negative percentage [3 Months]
The accuracy of the test will also be determined based on the percentage of false-positives and false-negatives compared to the gold standard clinical PCR test.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

The subject must be an adult (age>17) and either sex.
Written informed consent must be obtained prior to study enrollment.

A subject who is eighteen (18) years or older must be willing to give written informed consent and must agree to comply with study procedures.

Subject must be able to read and write in English.

Exclusion Criteria:

The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug, or device including either treatment or therapy.
The subject has previously participated in this research study.