COVID-19 Testing Pilot Study

Coronavirus Clinical Trial

Official title:

Feasibility Testing of a New COVID-19 Testing Platform

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04843878
• Other study ID #: 844488
• Status: Completed
• Start date: January 5, 2021
• Est. completion date: March 12, 2021

Study information

• Verified date: April 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: March 12, 2021
• Est. primary completion date: March 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• Diagnoses Disease
• Diagnostic Test, Routine
• Rapid Coronavirus Test

Intervention

Diagnostic Test:
• COVID Detect
The study is determining the efficacy of a new rapid COVID testing method.

Locations

Country	Name	City	State
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of Pennsylvania	Benjamin S. Abella, MD, MPhil, Cesar De La Fuente, Ph.D., Marcelo Der Torossian Torres, Ph.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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