Covid 19NCT05140005
GlowTest COVID-19 Antigen Home Test Kit QRI Use Study
A study testing GlowTest COVID-19 Antigen Home Test in people with Covid 19, run by Arion Bio at 1 site in United States.
Trial summary
The objective of the study is to determine the usability of the GlowTest COVID-19 Antigen Home Test in a simulated home use environment. This is an open label study to evaluate the usability of the GlowTest COVID-19 Antigen Home Test using information from the Quick Reference Instructions and website. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid 19
- What is being tested?
- GlowTest COVID-19 Antigen Home Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2021to 17 Dec 2021
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- An Institutional Review Board (IRB) approved informed consent/assent is signed and dated prior to any study-related activities.
- Males and females ages 2 and older.
- Subject is willing to provide a self-collected nasal swab sample. (If under the age of 14, the sample will be collected by an adult.)
- Subject agrees to complete all aspects of the study
Who cannot join
- Subject has a visual impairment that cannot be restored with glasses or contact lenses.
- Subject has prior medical or laboratory training.
- Subject uses home diagnostics, e.g., glucose meters, HIV tests.
- Subject has prior experience with home COVID test kits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GlowTest COVID-19 Antigen Home Test Kit Usability Study
The objective of the study is to determine the usability of the GlowTest COVID-19 Antigen Home Test in a simulated home use environment. This is an open label study to evaluate the usability of the GlowTest COVID-19 Antigen Home Test using information from the Quick Reference Instructions and website.
Read the detailed description
The purpose of this study is to evaluate the usability of the GlowTest COVID-19 Antigen Home Test in Home Use. The Arion Bio GlowTest COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection. The test is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older or adult collected anterior nares swab samples from individuals aged 2 to 13. The objective of the study is to determine the usability of the GlowTest COVID-19 Antigen Home Test in a simulated home use environment. This is an open label study to evaluate the usability of the GlowTest COVID-19 Antigen Home Test using information from the Quick Reference Instructions and website.
30 subjects (including both English speaking and Spanish speaking) will be split evenly into two sections: 15 participants testing themselves and 15 participants testing another person (child). There will be one testing site in the United States (US).
- Conditions
- Covid 19
- Being tested
- GlowTest COVID-19 Antigen Home Test
- Keywords
- Virus
- Medical subject headings
- COVID-19, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlowTest COVID-19 Antigen Home TestDiagnostic test
Also called GlowTest
diagnostic testing for Covid 19
| Study group | Role | What they receive |
|---|---|---|
| 15 subjects testing themselves | Other | 15 subjects will use the Glow Test Kit to test themselves for Covid 19. Receives: Diagnostic Test: GlowTest COVID-19 Antigen Home Test |
| 15 subjects testing someone else | Other | 15 subjects will use the Glow Test Kit to test someone else (a child) for Covid 19. Receives: Diagnostic Test: GlowTest COVID-19 Antigen Home Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
QRI Usability - Observer
Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation.
Measured: 90 minutes
QRI Usability - Participant
Assess the usability of the kit for home use based upon participant evaluation.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start6 Dec 2021
- Primary completion14 Dec 2021
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid 19Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 30 subjects split evenly into two sections: 15 participants testing themselves and 15 participants testing another person (child).
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arion Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CSSi Life Sciences
- Responsible party
- Sponsor
- Investigators
- Steven Geller, MD, Principal investigator, Centennial Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140005
- Sponsor's protocol ID
- AB-001-01
- Status last verified
- Dec 2021
- First submitted
- 29 Nov 2021
- Last updated
- 20 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 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GlowTest COVID-19 Antigen Home Test Kit Usability Study
- ClinicalTrials.gov ID
- NCT05140005
- Acronym / sponsor ID
- AB-001-01
- Conditions
- Covid 19
- Keywords
- Virus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Arion BioIndustry (pharma, biotech, devices)
- Collaborators
- CSSi Life Sciences
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 1 Dec 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.
The objective of the study is to determine the usability of the GlowTest COVID-19 Antigen Home Test in a simulated home use environment. This is an open label study to evaluate the usability of the GlowTest COVID-19 Antigen Home Test using information from the Quick Reference Instructions and website.
Detailed description
The purpose of this study is to evaluate the usability of the GlowTest COVID-19 Antigen Home Test in Home Use. The Arion Bio GlowTest COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection. The test is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older or adult collected anterior nares swab samples from individuals aged 2 to 13. The objective of the study is to determine the usability of the GlowTest COVID-19 Antigen Home Test in a simulated home use environment. This is an open label study to evaluate the usability of the GlowTest COVID-19 Antigen Home Test using information from the Quick Reference Instructions and website.
30 subjects (including both English speaking and Spanish speaking) will be split evenly into two sections: 15 participants testing themselves and 15 participants testing another person (child). There will be one testing site in the United States (US).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 30 subjects split evenly into two sections: 15 participants testing themselves and 15 participants testing another person (child).
| Arm | Type | Receives |
|---|---|---|
| 15 subjects testing themselves | Other | Diagnostic Test: GlowTest COVID-19 Antigen Home Test15 subjects will use the Glow Test Kit to test themselves for Covid 19. |
| 15 subjects testing someone else | Other | Diagnostic Test: GlowTest COVID-19 Antigen Home Test15 subjects will use the Glow Test Kit to test someone else (a child) for Covid 19. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- An Institutional Review Board (IRB) approved informed consent/assent is signed and dated prior to any study-related activities.
- Males and females ages 2 and older.
- Subject is willing to provide a self-collected nasal swab sample. (If under the age of 14, the sample will be collected by an adult.)
- Subject agrees to complete all aspects of the study
Key exclusion criteria (4 listed)
- Subject has a visual impairment that cannot be restored with glasses or contact lenses.
- Subject has prior medical or laboratory training.
- Subject uses home diagnostics, e.g., glucose meters, HIV tests.
- Subject has prior experience with home COVID test kits.
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 |
|---|---|---|
| GlowTest COVID-19 Antigen Home TestAlso: GlowTestdiagnostic testing for Covid 19 | Diagnostic test | 15 subjects testing someone else, 15 subjects testing themselves |
Primary outcome
QRI Usability - Observer
Time frame: 90 minutes
Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation.
QRI Usability - Participant
Time frame: 90 minutes
Assess the usability of the kit for home use based upon participant evaluation.
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 20 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.
Steven Geller, MD principal investigator
Centennial Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GlowTest COVID-19 Antigen Home Test in people with Covid 19, run by Arion Bio 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 4 inclusion and 4 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 20 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?
QRI Usability - Observer (time frame: 90 minutes). 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 20 Dec 2021.