SARS-CoV-2CoviDxNCT04750629
Clinical Evaluation of a Point-of-Care (POC), COVID-19 Rapid Antigen Test (CoviDx™)
An observational study of SARS-CoV-2 and Covid19, run by Lumos Diagnostics at 2 sites in United States.
Trial summary
Prospective study that will evaluate the clinical agreement of the CoviDx™ Rapid Antigen test compared to SARS-CoV-2 RT-PCR. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- SARS-CoV-2, Covid19
- What is being tested?
- POC CoviDx™ Rapid Antigen Test
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Feb 2021to 14 May 2021
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Symptomatic patients who are suspected of having SARS-CoV-2
Who may be able to join
- Nasopharyngeal swab collected for SARS-CoV-2 RT-PCR with EUA as per standard of care within 3 hours of CoviDx Rapid Antigen Swab collection
- First onset of COVID-19-like symptoms within the last 5 days
- ≥ 1 year of age
- Signed Informed Consent
Who cannot join
- Unable or unwilling to provide signed, Informed Consent
- Less than 1 year of age
- SARS-Cov-2 RT-PCR collection that occurred > 3 hours from CoviDx Rapid Antigen Swab collection
- First onset of COVID-19-like symptoms occurring more than 5 days from study visit
- Invalid or missing PCR test results
- Use of a non-high-sensitive SARS-CoV-2 test as the qualifying SARS-CoV-2 RT-PCR test (e.g., Abbott ID NOW, 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 or nasal swab
- Receipt of a COVID-19 vaccine or participation in a COVID-19 vaccine study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Doral Medical Research
Hialeah, Florida, 33016
Comprehensive Clinical Research
West Palm Beach, Florida, 33409
About this study
Official title: Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 CoviDx™ Rapid Antigen Test
Prospective study that will evaluate the clinical agreement of the CoviDx™ Rapid Antigen test compared to SARS-CoV-2 RT-PCR.
Read the detailed description
All patients who present with Covid-19-like symptoms within 5 days prior to consult, who consent to participate in the study, will undergo a nasopharyngeal swab (NP) collected for SARS-CoV-2 RT-PCR with EUA as per standard of care and nasal swab collection for CoviDx Rapid Antigen testing.
- Conditions
- SARS-CoV-2, Covid19
- Being tested
- POC CoviDx™ Rapid Antigen Test
- Keywords
- Antigen, Rapid, Point of care testing
- Medical subject headings
- COVID-19, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POC CoviDx™ Rapid Antigen TestDevice
All patients will have a nasal swab for CoviDx™ Rapid Antigen testing
| Study group | Role | What they receive |
|---|---|---|
| SARS-Cov-2 RT-PCR AND CoviDx Rapid Antigen Testing | Sequentially enrolled symptomatic patients who present for COVID-19 testing and have a swab collected for high-sensitive, SARS-CoV-2 RT-PCR testing per Standard of Care AND a swab for CoviDx™ Rapid Antigen testing. Receives: Device: POC CoviDx™ Rapid Antigen Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of SARS-CoV-2 antigen in nasal swab as compared to a high-sensitive SARS-CoV-2 RT-PCR granted Emergency Use Authorization (EUA) by the FDA
The primary outcome is the presence of SARS-CoV-2 antigen in nasal swab as compared to confirmatory diagnosis SARS-CoV-2 as determined by a high-sensitive SARS-CoV-2 RT-PCR granted Emergency Use Authorization (EUA) by the FDA
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start8 Feb 2021
- Primary completion7 May 2021
- Study completion14 May 2021
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
- 140 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
- NCT04750629
- Sponsor's protocol ID
- 21 0115
- Acronym
- CoviDx
- Status last verified
- Jun 2021
- First submitted
- 10 Feb 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 CoviDx™ Rapid Antigen Test
- ClinicalTrials.gov ID
- NCT04750629
- Acronym / sponsor ID
- CoviDx / 21 0115
- Conditions
- SARS-CoV-2, Covid19
- Keywords
- Antigen, Rapid, Point of care testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Lumos DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- Rapid Pathogen Screening
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 7 May 2021 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 11 Feb 2021 (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™ Rapid Antigen test compared to SARS-CoV-2 RT-PCR.
Detailed description
All patients who present with Covid-19-like symptoms within 5 days prior to consult, who consent to participate in the study, will undergo a nasopharyngeal swab (NP) collected for SARS-CoV-2 RT-PCR with EUA as per standard of care and nasal swab collection for CoviDx Rapid Antigen testing.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SARS-Cov-2 RT-PCR AND CoviDx Rapid Antigen Testing | – | Device: POC CoviDx™ Rapid Antigen TestSequentially enrolled symptomatic patients who present for COVID-19 testing and have a swab collected for high-sensitive, SARS-CoV-2 RT-PCR testing per Standard of Care AND a swab for CoviDx™ Rapid Antigen testing. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Symptomatic patients who are suspected of having SARS-CoV-2
Key inclusion criteria (4 listed)
- Nasopharyngeal swab collected for SARS-CoV-2 RT-PCR with EUA as per standard of care within 3 hours of CoviDx Rapid Antigen Swab collection
- First onset of COVID-19-like symptoms within the last 5 days
- ≥ 1 year of age
- Signed Informed Consent
Key exclusion criteria (8 listed)
- Unable or unwilling to provide signed, Informed Consent
- Less than 1 year of age
- SARS-Cov-2 RT-PCR collection that occurred > 3 hours from CoviDx Rapid Antigen Swab collection
- First onset of COVID-19-like symptoms occurring more than 5 days from study visit
- Invalid or missing PCR test results
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 |
|---|---|---|
| POC CoviDx™ Rapid Antigen TestAll patients will have a nasal swab for CoviDx™ Rapid Antigen testing | Device | SARS-Cov-2 RT-PCR AND CoviDx Rapid Antigen Testing |
Primary outcome
Sensitivity of SARS-CoV-2 antigen in nasal swab as compared to a high-sensitive SARS-CoV-2 RT-PCR granted Emergency Use Authorization (EUA) by the FDA
Time frame: 30 days
The primary outcome is the presence of SARS-CoV-2 antigen in nasal swab as compared to confirmatory diagnosis SARS-CoV-2 as determined by a high-sensitive SARS-CoV-2 RT-PCR granted Emergency Use Authorization (EUA) by the FDA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
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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.
2 sites 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 2 sites 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity of SARS-CoV-2 antigen in nasal swab as compared to a high-sensitive SARS-CoV-2 RT-PCR granted Emergency Use Authorization (EUA) by the FDA (time frame: 30 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 18 Jun 2021.