SARS-COV2 InfectionNCT05124496
Validation of HyperDetector for SARS-CoV-2
An observational study of SARS-COV2 Infection, run by HyperSpectral APD at 1 site in United States.
Trial summary
To evaluate the HyperDetector as a method to rapidly screen SARS-CoV-2 To determine the sensitivity and specificity of the screening assay performed on oral swab and saliva specimens, compared to a validated RT-PCR COVID-19 method using nasal or nasopharyngeal swabs and to separately collected nasal swabs, oral swabs… Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-COV2 Infection
- What is being tested?
- Screening Device
- Type of treatment
- Medical device
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2020to 30 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals obtaining Rt-PCR test
Who may be able to join
- Subjects at COVID-19 testing site for Rt-PCR test.
Who cannot join
- Minors under the age of 5
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the HyperDetector Digital Solution Screening Assay for Rapid Screening for Potential SARS-CoV-2 (COVID-19) Infection
To evaluate the HyperDetector as a method to rapidly screen SARS-CoV-2
To determine the sensitivity and specificity of the screening assay performed on oral swab and saliva specimens, compared to a validated RT-PCR COVID-19 method using nasal or nasopharyngeal swabs and to separately collected nasal swabs, oral swabs, oral rinse and saliva samples.
To determine the best workflow for using such an assay to reflex suspicious/positive samples to a validated RT-PCR COVID-19 assay.
- Conditions
- SARS-COV2 Infection
- Being tested
- Screening Device
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening DeviceDevice
Screening device comparing Rt-PCR positive and negative results to HyperDetector results
| Study group | Role | What they receive |
|---|---|---|
| Comparison to Rt-PCR | Not described Receives: Device: Screening Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
To determine the sensitivity of the screening assay
Measured: By 12/30/2022
Specificity
To determine the specificity of the screening assay
Measured: By 12/30/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start11 Dec 2020
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Why it stopped: Collected sufficient samples for analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-COV2 InfectionStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HyperSpectral APD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lauren Stack, Study director, HyperSpectral APD, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124496
- Sponsor's protocol ID
- 20204146
- Status last verified
- Nov 2021
- First submitted
- 15 Nov 2021
- Last updated
- 18 Nov 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 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the HyperDetector Digital Solution Screening Assay for Rapid Screening for Potential SARS-CoV-2 (COVID-19) Infection
- ClinicalTrials.gov ID
- NCT05124496
- Acronym / sponsor ID
- 20204146
- Conditions
- SARS-COV2 Infection
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Collected sufficient samples for analysis
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- HyperSpectral APDIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 18 Nov 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.
To evaluate the HyperDetector as a method to rapidly screen SARS-CoV-2
To determine the sensitivity and specificity of the screening assay performed on oral swab and saliva specimens, compared to a validated RT-PCR COVID-19 method using nasal or nasopharyngeal swabs and to separately collected nasal swabs, oral swabs, oral rinse and saliva samples.
To determine the best workflow for using such an assay to reflex suspicious/positive samples to a validated RT-PCR COVID-19 assay.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparison to Rt-PCR | – | Device: Screening Device |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals obtaining Rt-PCR test
Key inclusion criteria (1 listed)
- Subjects at COVID-19 testing site for Rt-PCR test.
Key exclusion criteria (1 listed)
- Minors under the age of 5
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 |
|---|---|---|
| Screening DeviceScreening device comparing Rt-PCR positive and negative results to HyperDetector results | Device | Comparison to Rt-PCR |
Primary outcome
Sensitivity
Time frame: By 12/30/2022
To determine the sensitivity of the screening assay
Specificity
Time frame: By 12/30/2022
To determine the specificity of the screening assay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 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.
Lauren Stack study director
HyperSpectral APD, LLC
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-COV2 Infection, run by HyperSpectral APD 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 1 inclusion and 1 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: paused, as of the sponsor's last update on 18 Nov 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?
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?
Sensitivity (time frame: By 12/30/2022). The study lists 2 primary outcomes in all. 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 Nov 2021; AzTrials last refreshed its copy on 3 Nov 2026.