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

NCT ID: NCT05403346

Last Updated: 2022-11-16

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-17
• Study Completion Date: 2022-10-31

Brief Summary

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

Detailed Description

Subjects who are currently experiencing symptoms associated with COVID-19 will be enrolled. Each enrolled subject will either self-collect one sample from the anterior nares or have the sample collected by another lay individual. Each subject will then have a mid-turbinate nasal swab sample collected for comparator test

Conditions

SARS-CoV-2; Covid19

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

CoviDx™ Covid-19 Antigen Self-Test

Intervention Type: DEVICE

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

Interventions

CoviDx™ Covid-19 Antigen Self-Test

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rapid Pathogen Screening

INDUSTRY

Sponsor Role: collaborator

Lumos Diagnostics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PAS Research

Tampa, Florida, United States

Countries

United States

Other Identifiers

CLP-0010

Identifier Type: -

Identifier Source: org_study_id