COVID-19NCT05629455
CareSuperb COVID-19 Antigen Test Usability
A study testing CareSuperb COVID-19 Antigen Home Test Kit in people with COVID-19, run by AccessBio, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the usability of the CareSuperb COVID-19 Antigen Home Test in Home Use. 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?
- CareSuperb COVID-19 Antigen Home Test Kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2022to 22 Nov 2022
- 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, if applicable, is signed and dated prior to any study-related activities.
- Male and female subjects 2 years of age and older.
- Subject is willing to provide a self-collected nasal swab sample. (If the subject is under the age of 14, an adult lay-user will collect the sample.)
- 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 knowledge of their current COVID-19 infection status.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CareSuperb COVID-19 Antigen Home Test Usability Study
The purpose of this study is to evaluate the usability of the CareSuperb COVID-19 Antigen Home Test in Home Use.
Read the detailed description
COVID-19 is a contagious respiratory illness, caused by infection with the novel coronavirus Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). This communicable disease is easily transmitted through aerosolized droplets containing the infectious virus. Infections with SARS-CoV-2 can have varying degrees of signs and symptoms, ranging from asymptomatic to severe. Individuals infected with SARS-CoV-2 are believed to be contagious from as early as two days prior to symptom onset to at least ten days after the onset of symptoms. The rapid detection of infections and contacts and the implementation of infection control measures are critical for mitigation of this virus.
The CareSuperb COVID-19 Antigen Home Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection. This kit is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older or adult lay user-collected anterior nares swab samples from individuals aged 2 to 13 years.
- Conditions
- COVID-19
- Being tested
- CareSuperb COVID-19 Antigen Home Test Kit
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CareSuperb COVID-19 Antigen Home Test KitDevice
At home COVID-19 antigen test kit
| Study group | Role | What they receive |
|---|---|---|
| individuals ages 14 years and older | Experimental | This kit is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older. Receives: Device: CareSuperb COVID-19 Antigen Home Test Kit |
| individuals aged 2 to 13 years | Experimental | This kit is intended for non-prescription home use with self-collected direct anterior nares swab samples.
If the subject is under the age of 14, an adult lay-user will collect the sample. Receives: Device: CareSuperb COVID-19 Antigen Home Test Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of Quick Reference Instruction
Primary Endpoints: 1. Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation.
Measured: One month
Usability of Test Kit
Primary Endpoints: 2. Assess the usability of the kit for home use based upon subject evaluation.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start17 Nov 2022
- Primary completion22 Nov 2022
- Study completion22 Nov 2022
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
- This is an open label study to evaluate the usability of the CareSuperb COVID-19 Antigen Home Test using information from the Quick Reference Instructions (QRI).
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AccessBio, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enrique Villa, MD, Principal investigator, L&A Morales Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629455
- Sponsor's protocol ID
- AB-1001
- Status last verified
- Feb 2023
- First submitted
- 18 Nov 2022
- Last updated
- 6 Feb 2023
- 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 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CareSuperb COVID-19 Antigen Home Test Usability Study
- ClinicalTrials.gov ID
- NCT05629455
- Acronym / sponsor ID
- AB-1001
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AccessBio, Inc.University, hospital or other
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 29 Nov 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.
The purpose of this study is to evaluate the usability of the CareSuperb COVID-19 Antigen Home Test in Home Use.
Detailed description
COVID-19 is a contagious respiratory illness, caused by infection with the novel coronavirus Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). This communicable disease is easily transmitted through aerosolized droplets containing the infectious virus. Infections with SARS-CoV-2 can have varying degrees of signs and symptoms, ranging from asymptomatic to severe. Individuals infected with SARS-CoV-2 are believed to be contagious from as early as two days prior to symptom onset to at least ten days after the onset of symptoms. The rapid detection of infections and contacts and the implementation of infection control measures are critical for mitigation of this virus.
The CareSuperb COVID-19 Antigen Home Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection. This kit is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older or adult lay user-collected anterior nares swab samples from individuals aged 2 to 13 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open label study to evaluate the usability of the CareSuperb COVID-19 Antigen Home Test using information from the Quick Reference Instructions (QRI).
| Arm | Type | Receives |
|---|---|---|
| individuals ages 14 years and older | Experimental | Device: CareSuperb COVID-19 Antigen Home Test KitThis kit is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older. |
| individuals aged 2 to 13 years | Experimental | Device: CareSuperb COVID-19 Antigen Home Test KitThis kit is intended for non-prescription home use with self-collected direct anterior nares swab samples. If the subject is under the age of 14, an adult lay-user will collect the sample. |
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, if applicable, is signed and dated prior to any study-related activities.
- Male and female subjects 2 years of age and older.
- Subject is willing to provide a self-collected nasal swab sample. (If the subject is under the age of 14, an adult lay-user will collect the sample.)
- 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 knowledge of their current COVID-19 infection status.
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 |
|---|---|---|
| CareSuperb COVID-19 Antigen Home Test KitAt home COVID-19 antigen test kit | Device | individuals aged 2 to 13 years, individuals ages 14 years and older |
Primary outcome
Usability of Quick Reference Instruction
Time frame: One month
Primary Endpoints: 1. Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation.
Usability of Test Kit
Time frame: One month
Primary Endpoints: 2. Assess the usability of the kit for home use based upon subject 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 6 Feb 2023.
- 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.
Enrique Villa, MD principal investigator
L&A Morales Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CareSuperb COVID-19 Antigen Home Test Kit in people with COVID-19, run by AccessBio, Inc. 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 6 Feb 2023. 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?
Usability of Quick Reference Instruction (time frame: One month). 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 6 Feb 2023.