Clinical trial NCT05403346: Clinical Evaluation of a COVID-19 Antigen Self-Test (CoviDx™)
Official title: Clinical Evaluation of a SARS-CoV-2 CoviDx™COVID-19 Antigen Self-Test
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: SARS-CoV-2
Covid19
Keywords: Antigen
Rapid Point of care testing
Self testing
Lead sponsor: Lumos Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: Rapid Pathogen Screening
First posted: 2022-06-03
Enrollment: 45
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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

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

Primary outcomes:
measure: 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
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: PAS Research
state: Florida
Study officials:
References: