COVID-19 Testing Pilot Study

NCT ID: NCT04843878

Last Updated: 2021-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

326 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-05

Study Completion Date

2021-03-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diagnostic Test, Routine Coronavirus Diagnoses Disease Rapid Coronavirus Test

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Positive

Subjects that tested positive for COVID-19 based on the clinical gold standard PCR test.

COVID Detect

Intervention Type DIAGNOSTIC_TEST

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.

COVID Detect

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

COVID Detect

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Benjamin S. Abella, MD, MPhil

UNKNOWN

Sponsor Role collaborator

Marcelo Der Torossian Torres, Ph.D.

UNKNOWN

Sponsor Role collaborator

Cesar De La Fuente, Ph.D.

UNKNOWN

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Benjamin S Abella, MD, MPhil

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

844488

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

COVID Breath Test - Ancon
NCT04760639 COMPLETED
Screening for COVID-19
NCT04615208 WITHDRAWN