SARS-CoV-2CoviDx™NCT05403346
Clinical Evaluation of a COVID-19 Antigen Self-Test (CoviDx™)
An observational study of SARS-CoV-2 and Covid19, run by Lumos Diagnostics at 1 site in United States.
Trial summary
Prospective study that will evaluate the clinical agreement of the CoviDx™ Self test compared to SARS-CoV-2 RT-PCR. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- SARS-CoV-2, Covid19
- What is being tested?
- CoviDx™ Covid-19 Antigen Self-Test
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2022to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of a SARS-CoV-2 CoviDx™COVID-19 Antigen Self-Test
Prospective study that will evaluate the clinical agreement of the CoviDx™ Self test compared to SARS-CoV-2 RT-PCR.
Read the 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
- Being tested
- CoviDx™ Covid-19 Antigen Self-Test
- Keywords
- Antigen, Rapid Point of care testing, Self testing
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoviDx™ Covid-19 Antigen Self-TestDevice
All patients will self-collect a mid-turbinate nasal swab for CoviDx™ Covid-19 Antigen self-testing
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CoviDx™ Covid-19 Antigen Self-Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start17 May 2022
- Primary completion1 Aug 2022
- Study completion31 Oct 2022
Why it stopped: Study was terminated due to the difficulty to enrol patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumos Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rapid Pathogen Screening
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403346
- Sponsor's protocol ID
- CLP-0010
- Acronym
- CoviDx™
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a SARS-CoV-2 CoviDx™COVID-19 Antigen Self-Test
- ClinicalTrials.gov ID
- NCT05403346
- Acronym / sponsor ID
- CoviDx™ / CLP-0010
- Conditions
- SARS-CoV-2, Covid19
- Keywords
- Antigen, Rapid Point of care testing, Self testing
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was terminated due to the difficulty to enrol patients
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Lumos DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- Rapid Pathogen Screening
- Study start
- 17 May 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SARS COv-2 RT-PCR AND Self collected CoviDx Covid-19 Antigen Self-Test | – | Device: CoviDx™ Covid-19 Antigen Self-TestSequentially 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. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoviDx™ Covid-19 Antigen Self-TestAll patients will self-collect a mid-turbinate nasal swab for CoviDx™ Covid-19 Antigen self-testing | Device | SARS COv-2 RT-PCR AND Self collected CoviDx Covid-19 Antigen Self-Test |
Primary outcome
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
Time frame: 60 days
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).
Results and safety
The study was stopped early (reason given: Study was terminated due to the difficulty to enrol patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
Related trials for SARS-CoV-2
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 and Covid19, run by Lumos Diagnostics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was terminated due to the difficulty to enrol patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.