Clinical trial NCT04568356: A Clinical Evaluation of COVID-19 Rapid Point of Care Antigen Tests
Official title: A Clinical Performance Evaluation of the SARS-COV-2 Direct Antigen Rapid Test "DART"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS CoV-2
Keywords: COVID-19
Lead sponsor: E25Bio, Inc.
Sponsor class: INDUSTRY
Collaborators: name: SCRI Development Innovations, LLC
First posted: 2020-09-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Percent Positive Agreement and Negative Percent Agreement
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: JFK Medical Center
state: Florida
city: Miami
country: United States
facility: Kendall Regional
state: Florida
city: Miami
country: United States
facility: Aventura Hospital and Medical Center
state: Florida
Study officials:
affiliation: HCA Healthcare Director of Research. Neuroscience and Orthopedic
name: Gina Remington, RN MSN
role: STUDY_DIRECTOR
affiliation: SCRI Development Innovations, LLC
name: Patrice Feaster, RN
role: STUDY_DIRECTOR
affiliation: JFK Medical Center
name: Klepler N De Almeida, MD
role: PRINCIPAL_INVESTIGATOR
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