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COVID-19 Testing Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04843878
Recruitment Status : Completed
First Posted : April 14, 2021
Last Update Posted : April 14, 2021
Sponsor:
Collaborators:
Benjamin S. Abella, MD, MPhil
Marcelo Der Torossian Torres, Ph.D.
Cesar De La Fuente, Ph.D.
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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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
Diagnostic Test, Routine Coronavirus Diagnoses Disease Rapid Coronavirus Test Diagnostic Test: COVID Detect

Study Design
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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 : January 5, 2021
Actual Primary Completion Date : March 12, 2021
Actual Study Completion Date : March 12, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04843878


Locations
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United States, Pennsylvania
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Benjamin S. Abella, MD, MPhil
Marcelo Der Torossian Torres, Ph.D.
Cesar De La Fuente, Ph.D.
Investigators
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Principal Investigator: Benjamin S Abella, MD, MPhil University of Pennsylvania
More Information
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04843878    
Other Study ID Numbers: 844488
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans to share IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pennsylvania:
COVID-19
Detect
Pandemic
 Symptomatic
Asymptomatic
Anterior Nares
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
 Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases