COVID-19 Testing Pilot Study

Completed

• Conditions: Rapid Coronavirus Test; Diagnostic Test, Routine; Coronavirus; Diagnoses Disease
• Interventions: Diagnostic Test: COVID Detect

• Registration Number: NCT04843878
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-01-05
• Primary Completion: 2021-03-12
• Study Completion: 2021-03-12
• Status Verified: 2021-04
• Study First Submitted: 2021-04-09
• Study First Submitted QC: 2021-04-09
• Last Update Submitted: 2021-04-09
• Study First Posted: 2021-04-14
• Last Update Posted: 2021-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Negative	COVID Detect	Subjects that tested negative for COVID-19 based on the clinical gold standard PCR test.
Positive	COVID Detect	Subjects that tested positive for COVID-19 based on the clinical gold standard PCR test.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Penn Presbyterian Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States