Covid19NCT04667442
Investigational Performance Evaluation of the Nanomix eLab® COVID-19 Rapid Antigen Panel With Samples From COVID-19 Positive and Negative Human Subjects
An observational study of Covid19, run by Nanomix at 1 site in United States.
Trial summary
Prospective samples will be collected to evaluate the agreement between a EUA RT-PCR test as the comparator method against the Nanomix eLab® system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional)
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 14 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will include both symptomatic and asymptomatic subjects. Although to enrich for COVID-19 positive subjects, the study will preferentially identify and enrolled subjects who have been or will be tested by EUA RT-PCR including those who are symptomatic or hospitalized with symptoms, specifically those within 7-days of symptom onset that meet the study enrollment inclusion and exclusion criteria.
Who may be able to join
- 18 years of age or older
- Male or Female
- Willing and able to provide informed consent
- Symptomatic or asymptomatic
- The EUA RT-PCR sample must be collected within one (1) day of the sample collected for testing by the Nanomix eLab® COVID-19 Rapid Antigen Panel.
Who cannot join
- Subjects without both a valid EUA RT-PCR test result and a valid Nanomix eLab® COVID-19 Rapid Antigen results will be excluded
- Subjects not being able to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigational Performance Evaluation of the Nanomix eLab® COVID-19 Rapid Antigen Panel With Samples From COVID-19 Positive and Negative Human Subjects
Prospective samples will be collected to evaluate the agreement between a EUA RT-PCR test as the comparator method against the Nanomix eLab® system.
- Conditions
- Covid19
- Being tested
- Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional)Diagnostic test
COVID-19 Rapid Antigen Diagnostic Test
| Study group | Role | What they receive |
|---|---|---|
| EUA RT-PCR positive | Not described Receives: Diagnostic Test: Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional) | |
| EUA RT-PCR negative | Not described Receives: Diagnostic Test: Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate clinical agreement between an EUA RT-PCR methodology and the Nanomix eLab® COVID-19 Rapid Antigen Panel
An analysis of the result from subjects who have been or will be tested by EUA RT-PCR will be performed to establish the sensitivity by positive percent agreement (PPA) and the specificity by negative percent agreement (NPA) of the Nanomix eLab® COVID-19 Rapid Antigen Panel and a confirmatory EUA RT-PCR method.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start1 Dec 2020
- Primary completion14 Dec 2021
- Study completion14 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Cross-sectional
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanomix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tina Landess, Study director, Nanomix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667442
- Sponsor's protocol ID
- Nanomix CVAG-202
- Status last verified
- Dec 2021
- First submitted
- 10 Dec 2020
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigational Performance Evaluation of the Nanomix eLab® COVID-19 Rapid Antigen Panel With Samples From COVID-19 Positive and Negative Human Subjects
- ClinicalTrials.gov ID
- NCT04667442
- Acronym / sponsor ID
- Nanomix CVAG-202
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- NanomixIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 14 Dec 2020 (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 samples will be collected to evaluate the agreement between a EUA RT-PCR test as the comparator method against the Nanomix eLab® system.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUA RT-PCR positive | – | Diagnostic Test: Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional) |
| EUA RT-PCR negative | – | Diagnostic Test: Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include both symptomatic and asymptomatic subjects. Although to enrich for COVID-19 positive subjects, the study will preferentially identify and enrolled subjects who have been or will be tested by EUA RT-PCR including those who are symptomatic or hospitalized with symptoms, specifically those within 7-days of symptom onset that meet the study enrollment inclusion and exclusion criteria.
Key inclusion criteria (5 listed)
- 18 years of age or older
- Male or Female
- Willing and able to provide informed consent
- Symptomatic or asymptomatic
- The EUA RT-PCR sample must be collected within one (1) day of the sample collected for testing by the Nanomix eLab® COVID-19 Rapid Antigen Panel.
Key exclusion criteria (2 listed)
- Subjects without both a valid EUA RT-PCR test result and a valid Nanomix eLab® COVID-19 Rapid Antigen results will be excluded
- Subjects not being able to provide consent
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 |
|---|---|---|
| Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional)COVID-19 Rapid Antigen Diagnostic Test | Diagnostic test | EUA RT-PCR negative, EUA RT-PCR positive |
Primary outcome
Demonstrate clinical agreement between an EUA RT-PCR methodology and the Nanomix eLab® COVID-19 Rapid Antigen Panel
Time frame: Up to 1 year
An analysis of the result from subjects who have been or will be tested by EUA RT-PCR will be performed to establish the sensitivity by positive percent agreement (PPA) and the specificity by negative percent agreement (NPA) of the Nanomix eLab® COVID-19 Rapid Antigen Panel and a confirmatory EUA RT-PCR method.
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 27 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Tina Landess study director
Nanomix
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 Covid19, run by Nanomix 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 2 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 27 Dec 2021. 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 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?
Demonstrate clinical agreement between an EUA RT-PCR methodology and the Nanomix eLab® COVID-19 Rapid Antigen Panel (time frame: Up to 1 year). 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 27 Dec 2021.