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

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: NCT04568356
Recruitment Status : Completed
First Posted : September 29, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
SCRI Development Innovations, LLC
Information provided by (Responsible Party):
E25Bio, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
SARS CoV-2 Diagnostic Test: Direct Antigen Tests for COVID-19 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Clinical Performance Evaluation of the SARS-COV-2 Direct Antigen Rapid Test "DART"
Actual Study Start Date : April 24, 2020
Actual Primary Completion Date : June 12, 2020
Actual Study Completion Date : September 24, 2020
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04568356


Locations
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United States, Florida
JFK Medical Center
Miami, Florida, United States, 033401
Kendall Regional
Miami, Florida, United States, 33175
Aventura Hospital and Medical Center
Miami, Florida, United States, 33180
Sponsors and Collaborators
E25Bio, Inc.
SCRI Development Innovations, LLC
Investigators
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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
  Study Documents (Full-Text)

Documents provided by E25Bio, Inc.:
Informed Consent Form  [PDF] April 25, 2020
Study Protocol  [PDF] April 19, 2020

More Information
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Publications of Results:
Bosch I, de Puig H, Hiley M, Carré-Camps M, Perdomo-Celis F, Narváez CF, Salgado DM, Senthoor D, O'Grady M, Phillips E, Durbin A, Fandos D, Miyazaki H, Yen CW, Gélvez-Ramírez M, Warke RV, Ribeiro LS, Teixeira MM, Almeida RP, Muñóz-Medina JE, Ludert JE, Nogueira ML, Colombo TE, Terzian ACB, Bozza PT, Calheiros AS, Vieira YR, Barbosa-Lima G, Vizzoni A, Cerbino-Neto J, Bozza FA, Souza TML, Trugilho MRO, de Filippis AMB, de Sequeira PC, Marques ETA, Magalhaes T, Díaz FJ, Restrepo BN, Marín K, Mattar S, Olson D, Asturias EJ, Lucera M, Singla M, Medigeshi GR, de Bosch N, Tam J, Gómez-Márquez J, Clavet C, Villar L, Hamad-Schifferli K, Gehrke L. Rapid antigen tests for dengue virus serotypes and Zika virus in patient serum. Sci Transl Med. 2017 Sep 27;9(409). pii: eaan1589. doi: 10.1126/scitranslmed.aan1589.

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Responsible Party: E25Bio, Inc.
ClinicalTrials.gov Identifier: NCT04568356    
Other Study ID Numbers: E25001_NEU2012
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: One month after the USA-FDA approval date and for the duration of one year after the date of approval
Access Criteria: via email to: Irene Bosch, PhD at ibosch@e25bio.com
URL: http://www.e25bio.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by E25Bio, Inc.:
COVID-19