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OpenTrials
Completed

NCT Number: NCT04843878

COVID-19 Testing Pilot Study

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.

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Key information

Conditions

Diagnostic Test, Routine COVID-19 Coronaviridae Infections Coronavirus Coronavirus Infections Diagnoses Disease Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Rapid Coronavirus Test Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 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.

Treatment and study plan

COVID Detect

Diagnostic Test

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

Primary outcomes

  1. Device Accuracy - Positive and Negative Percentage

    Time frame: 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.

  2. Device Accuracy - False positive and False negative percentage

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

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

Registry information

Official study title

Feasibility Testing of a New COVID-19 Testing Platform

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 14, 2021
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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