A Clinical Evaluation of COVID-19 Rapid Point of Care Antigen Tests

October 16, 2020 updated by: E25Bio, Inc.

A Clinical Performance Evaluation of the SARS-COV-2 Direct Antigen Rapid Test "DART"

The current standard of care for diagnosis of Severe Acute Respiratory Syndrome associated Coronavirus -2 (SARS-CoV-2 ) infection involves sample collection to be prepared and measured via real time-polymerase chain reaction (RT-PCR). This process is often time consuming depending on the level of automation within the laboratory processing the samples. In many cases, sample turn-around times can take hours to several days. A rapid assay that does not require the sophisticated laboratory equipment and techniques could provide a significant advantage to the way practitioners screen and ultimately treat patients. Moreover, the collection of samples from the nasal nares should prove useful and less invasive. The study aims to validate the use of nasal swabs and also to validate the antigen test using nasal swabs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A rapid point of care bioassay for the detection of virus proteins will be compared to the hospital validated RT-PCR detection standard. Nasopharyngeal, nasal and saliva samples will be collected along with hospital standard of care collection. Nasal and saliva will be self-administered collection. Samples will be collected in an Emergency Room setting from up to 100 subjects who entered the hospital over concerns about SARS-CoV-2. The goal is to collect a minimum of N=30 confirmed Covid-19 positive subjects and N=30 confirmed Covid-19 negative subjects of comparable ages, genders and races. The SARS-CoV-2 Direct Antigen Rapid Test ("DART") is an immunoassay for point-of-care, qualitative detection of SARS-CoV-2 viral particles/secreted protein in nasopharyngeal swabs from suspected patients with Coronavirus Disease 2019 or COVID-19 infection. Dipsticks are printed with a monoclonal antibody that binds the signature SARS-CoV-2 viral particles/protein (Test line) and a control antibody (Control line) for quality control. A second monoclonal antibody is attached to gold nanoparticles (conjugate) and quencher buffer, and mixed with the patient samples, though in the near future the final format will contain the dry conjugate. The SARS-CoV-2 viral particles/Spike protein attach to both antibodies resulting in a visual line on the test strip within 15 minutes. Prior experience for detection virus and viral proteins via antibody binding using lateral flow are E25Bio portfolio platform for dengue, Zika and Chikungunya viruses among others.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 033401
        • JFK Medical Center
      • Miami, Florida, United States, 33175
        • Kendall Regional
      • Miami, Florida, United States, 33180
        • Aventura Hospital and Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provision of verbal informed consent form
  • Subject is suspected case of COVID-19 by clinical criteria a patient with acute respiratory tract infection (sudden onset of at least one of the following: cough, fever, shortness of breath, fatigue, decreased appetite, myalgia)
  • No other etiology that fully explains the clinical presentation
  • With or without a history of close contact with a confirmed or probable COVID-19 case in the last 14 days prior to onset of symptoms.
  • Subject is an appropriate candidate for Nasopharyngeal sample collection
  • Subject is willing to provide nasopharyngeal swab and saliva samples

Exclusion Criteria:

• Individuals who present to ER with 10 or greater days of COVID-19 Related Symptoms, (Fever, Cough, Fatigue, Decreased Appetite, Shortness of Breath, Myalgia) or post-defervescence and/or convalescence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Antigen rapid test for COVID-19
The same group of patients participated in two arms of the study, one arm was for obtaining data on the rapid antigen test for COVID-19, the comparator arm was to obtain data from the RT-PCR
Diagnostic test: Direct Antigen Tests for COVID-19
Rapid Antigen diagnostic device performance comparative to RT-PCR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Positive Agreement and Negative Percent Agreement
Time Frame: 90 days
Calculate the performance of the antigen test compared to PCR using nasopharyngeal swab samples
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

E25Bio, Inc.

Collaborators

SCRI Development Innovations, LLC

Investigators

  • Study Director: Gina Remington, RN MSN, HCA Healthcare Director of Research. Neuroscience and Orthopedic
  • Study Director: Patrice Feaster, RN, SCRI Development Innovations, LLC
  • Principal Investigator: Klepler N De Almeida, MD, JFK Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2020

Primary Completion (Actual)

June 12, 2020

Study Completion (Actual)

September 24, 2020

Study Registration Dates

First Submitted

September 27, 2020

First Submitted That Met QC Criteria

September 27, 2020

First Posted (Actual)

September 29, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 16, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E25001_NEU2012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The sponsor E25Bio, Inc. is in agreement to share the outcome of this Clinical Trial. Because the device product has not been previously approved or cleared by FDA, we will be publicly posting not earlier than the date of FDA approval or clearance.

IPD Sharing Time Frame

One month after the USA-FDA approval date and for the duration of one year after the date of approval

IPD Sharing Access Criteria

via email to: Irene Bosch, PhD at ibosch@e25bio.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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