Diagnostic Test, RoutineNCT04843878
COVID-19 Testing Pilot Study
An observational study of Diagnostic Test, Routine and Coronavirus, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diagnostic Test, Routine, Coronavirus, Diagnoses Disease
- What is being tested?
- COVID Detect
- How many people
- 326 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2021to 12 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- The subject must be an adult (age>17) and either sex.
- Written informed consent must be obtained prior to study enrollment.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
- Being tested
- COVID Detect
- Keywords
- COVID-19, Detect, Pandemic, Symptomatic, Asymptomatic, Anterior Nares
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID DetectDiagnostic test
The study is determining the efficacy of a new rapid COVID testing method.
| Study group | Role | What they receive |
|---|---|---|
| Positive | Subjects that tested positive for COVID-19 based on the clinical gold standard PCR test. Receives: Diagnostic Test: COVID Detect | |
| Negative | Subjects that tested negative for COVID-19 based on the clinical gold standard PCR test. Receives: Diagnostic Test: COVID Detect |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start5 Jan 2021
- Primary completion12 Mar 2021
- Study completion12 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic Test, RoutineStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Benjamin S. Abella, MD, MPhil, Marcelo Der Torossian Torres, Ph.D., Cesar De La Fuente, Ph.D.
- Responsible party
- Sponsor
- Investigators
- Benjamin S Abella, MD, MPhil, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843878
- Sponsor's protocol ID
- 844488
- Status last verified
- Apr 2021
- First submitted
- 9 Apr 2021
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Testing of a New COVID-19 Testing Platform
- ClinicalTrials.gov ID
- NCT04843878
- Acronym / sponsor ID
- 844488
- Keywords
- COVID-19, Detect, Pandemic, Symptomatic, Asymptomatic, Anterior Nares
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Benjamin S. Abella, MD, MPhil, Marcelo Der Torossian Torres, Ph.D., Cesar De La Fuente, Ph.D.
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive | – | Diagnostic Test: COVID DetectSubjects that tested positive for COVID-19 based on the clinical gold standard PCR test. |
| Negative | – | Diagnostic Test: COVID DetectSubjects that tested negative for COVID-19 based on the clinical gold standard PCR test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- The subject must be an adult (age>17) and either sex.
- Written informed consent must be obtained prior to study enrollment.
- Subject must be able to read and write in English.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID DetectThe study is determining the efficacy of a new rapid COVID testing method. | Diagnostic test | Negative, Positive |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Individual participant dataSharing planned: No. No plans to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin S Abella, MD, MPhil principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnostic Test, Routine and Coronavirus, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Accuracy - Positive and Negative Percentage (time frame: 3 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.