COVID-19 Testing Pilot Study

Feasibility Testing of a New COVID-19 Testing Platform

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.

Study Overview

• Status: Completed
• Conditions: Diagnoses Disease; Coronavirus; Diagnostic Test, Routine; Rapid Coronavirus Test
• Intervention / Treatment: Diagnostic test: COVID Detect

• Study Type: Observational
• Enrollment (Actual): 326

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Presbyterian Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited as they present for treatment at ambulatory Penn testing sites. Subjects who present with symptoms of COVID-19-like illness at the study site as defined in Inclusion Criteria below and have come to the study site for routine evaluation of their condition may be enrolled in this clinical study. Males and females aged >17 years old may be enrolled, and should be represented in proportions representative of the population.

Description

Inclusion Criteria:

1. The subject must be an adult (age>17) and either sex.

2. Written informed consent must be obtained prior to study enrollment.

   a. 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.

3. Subject must be able to read and write in English.

Exclusion Criteria:

1. 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.
2. The subject has previously participated in this research study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Accuracy - Positive and Negative Percentage	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.	3 Months
Device Accuracy - False positive and False negative percentage	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.	3 Months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Benjamin S. Abella, MD, MPhil; Marcelo Der Torossian Torres, Ph.D.; Cesar De La Fuente, Ph.D.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 5, 2021
• Primary Completion (ACTUAL): March 12, 2021
• Study Completion (ACTUAL): March 12, 2021

Study Registration Dates

• First Submitted: April 9, 2021
• First Submitted That Met QC Criteria: April 9, 2021
• First Posted (ACTUAL): April 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 9, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; Asymptomatic; Pandemic; Symptomatic; Detect; Anterior Nares
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: 844488

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No