Clinical Evaluation of a COVID-19 Antigen Self-Test (CoviDx™)

NCT05403346 | Terminated DMC FDA Device

• 1 other identifier: CLP-0010
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective study that will evaluate the clinical agreement of the CoviDx™ Self test compared to SARS-CoV-2 RT-PCR.

Conditions

SARS-CoV-2; Covid19

Keywords

Antigen; Rapid Point of care testing; Self testing

Outcome Measures

Primary Outcomes (1)

• Performance of CoviDx Covid-19 Antigen Self-Test in nasal swab as compared to a high-sensitive SARSCoV- 2 RT-PCR granted Emergency Use Authorization (EUA) by the FDA

  Evaluate the performance (positive percent agreement (PPA) and negative percent agreement (NPA)) of the CoviDx™ COVID-19 Antigen Self-Test for the detection of SARS-CoV-2 virus antigen in anterior nasal swab (NS) samples collected by lay users compared to results obtained from by a high-sensitive SARS-CoV-2 RT-PCR granted Emergency Use Authorization (EUA) by the FDA (comparator test).

  60 days

Study Arms (1)

SARS COv-2 RT-PCR AND Self collected CoviDx Covid-19 Antigen Self-Test

Sequentially enrolled symptomatic patients will have a nasal swab collected for high-sensitive SARS-CoV-2 RT-PCR testing as comparator and self collect a nasal swab for CoviDx™ Covid-19 Antigen self-testing. Order of tests will be performed following a randomization scheme.

Device: CoviDx™ Covid-19 Antigen Self-Test

Interventions

CoviDx™ Covid-19 Antigen Self-Test DEVICE

All patients will self-collect a mid-turbinate nasal swab for CoviDx™ Covid-19 Antigen self-testing

SARS COv-2 RT-PCR AND Self collected CoviDx Covid-19 Antigen Self-Test

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Lay users who do not have medical or laboratory experience significant experience performing repeated self-testing. Subjects will be 2 years of age or older and have symptoms of COVID-19 that started ≤ 5 days from their study visit

You may qualify if:

• Mid-turbinate nasal swab collected for SARS-CoV-2 RT-PCR at the same time of CoviDx Rapid Antigen swab collection
• Symptomatic subjects suspected of having COVID-19, first onset of COVID-19-like symptoms (e.g., chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea) should not have started more than 5 days from the time of the study visit. Symptoms must be present on the day of CoviDx testing.
• ≥ 2 years of age
• Participants between 2-13 years of age, inclusive, must participate with a guardian who will be collecting the swab.
• Signed Informed Consent

You may not qualify if:

• Participants with prior medical or laboratory training
• Unable or unwilling to provide signed, Informed Consent
• Less than 2 years of age
• Received a positive diagnostic test result for COVID-19 in the past 14 days
• Received a negative diagnostic test result for COVID-19 in the last 18 hours
• Study Comparator collection that occurred \> 3 hours from CoviDx swab collection
• For symptomatic participants: first onset of COVID-19-like symptoms occurring more than 5 days from study visit
• Invalid or missing study comparator test results
• Use of a non-high-sensitive SARS-CoV-2 test as the comparator SARS-CoV-2 RT-PCR test (e.g., rapid molecular, rapid antigen tests, tests that do not have FDA EUA, a test that was not approved by Sponsor for use in the study)
• Enrollment in another study involving the collection of a nasopharyngeal, mid-turbinate nasal swab or anterior nasal swab within 6 hours of CoviDx testing.
• Indicates they would not use a COVID-19 diagnostic test kit in real life
• Taking any of the following medications or treatments within 7 days of study visit (antivirals (e.g., Remdesivir, Paxlovid) and/or monoclonal antibodies (e.g., REGEN-COV (casirivimab, imdevimab), Sotrovimab (Xevudy), Evusheld)
• Nasal spray administration in the last 48 hours

Sponsors & Collaborators

• Lumos Diagnostics: lead
• Rapid Pathogen Screening: collaborator

Study Sites (1)

PAS Research

Tampa, Florida, 33613, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Mid turbinate nasal swabs

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 3, 2022
• Study Start: May 17, 2022
• Primary Completion: August 1, 2022
• Study Completion: October 31, 2022
• Last Updated: November 16, 2022

Record last verified: 2022-06

Locations

US (1)