COVID-19NCT05771714
Clinical Performance Evaluation of the CareSuperb™ COVID-19 Antigen Home Test
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 accuracy of the CareSuperb™ COVID-19 Antigen Home Test (sensitivity and specificity) in a simulated home use environment when compared to the Roche cobas SARS-CoV-2 (EUA200009), Hologic Panther Fusion SARS-CoV-2 (EUA200014), and Roche cobas SARS-CoV-2 Nucleic acid test for… 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
- 786 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to 11 May 2023
- 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 and assent (if applicable) is signed and dated prior to any study related activities.
- Male and female subjects 2 years of age and older, presenting to the site seeking COVID-19 testing. If symptomatic, symptom onset must be within 5 days of enrollment into the study.
- 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 lay user.)
- Subject is willing to have nasal swabs collected by a member of the study staff.
- Subject agrees to complete all aspects of the study.
Who cannot join
- Subject is undergoing treatment currently and/or within the past 30 days of study enrollment with medication to treat SARS-CoV-2, which may include but is not limited to Paxlovid, Remdesivir.
- Subject is receiving convalescent plasma therapy for SARS-CoV-2.
- Subject used a nasal wash or nasal aspirate treatment on enrollment day.
- Subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic treatment or therapy, or drug.
- Subjects who report or whose clinical status or history indicates that they take biotin >10 mg per day.
- Subjects who previously enrolled in this study.
Show all 11Show fewer
- Subject has a visual impairment that cannot be restored with glasses or contact lenses.
- Subject has prior medical or laboratory training.
- Subject has prior knowledge of their current COVID-19 infection status.
- Subject with a history of frequent or difficult to control nosebleeds within the last fourteen (14) days.
- Subject has received a positive COVID-19 test result within the past sixty (60) days.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the accuracy of the CareSuperb™ COVID-19 Antigen Home Test (sensitivity and specificity) in a simulated home use environment when compared to the Roche cobas SARS-CoV-2 (EUA200009), Hologic Panther Fusion SARS-CoV-2 (EUA200014), and Roche cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (EUA210388) high sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assays.
Read the detailed description
This is an open label, prospective, randomized clinical agreement study to evaluate the sensitivity and specificity of the CareSuperb™ COVID-19 Antigen Home Test when a lay person conducts the test on themselves, or another study participant, as compared to EUA authorized high sensitivity RT-PCR comparator tests.
Patients presenting to the study site for COVID-19 testing who have signed the informed consent and assent, if applicable, and who meet the eligibility criteria will be enrolled in the study. Upon enrollment, the subject will be assigned a unique subject identification (ID) number. After obtaining relevant demographic and medical information, testing will ensue.
The first sample, collected by the clinical research staff, will be for the standard of care (SOC). Results of the SOC test will be used for subject treatment and management. To mitigate any potential bias which may affect the subject's visual interpretation of the CareSuperb™ test result, the study staff will not provide the SOC test results to the subject until after the results of the CareSuperb™ test are read by the subject.
There will be a 15-minute minimum wait period prior to the collection of the second anterior nares swab sample and an additional 15-minute minimum wait period between the second and third sample collection.
For Even numbered subjects, the second sample, collected by a study staff member, will be used for the RT-PCR comparator tests. The third sample will be collected and tested by the lay user, using the CareSuperb™ COVID-19 Antigen Home Test.
For Odd numbered subjects, the second sample will be collected and tested by the lay user using the CareSuperb™ COVID-19 Antigen Home Test. The third sample will be collected by a study staff member and will be used for the RT-PCR comparator tests.
The clinical study staff member will photograph each subject's test cartridge, labeled with their corresponding subject ID number. Additionally, the study staff member will record whether or not they agree with the test result's interpretation by the subject, and if not, why.
The RT-PCR sample will be placed in the provided viral transport medium (VTM) vial and stored in a -70°C freezer until ready for shipment to the central lab.
The comparator samples for RT-PCR testing will be shipped to the central lab weekly, unless directed otherwise by either the sponsor or the Clinical Research Organization (CRO). Specimens should be shipped on dry ice for next day delivery, avoiding weekend delivery. RT-PCR testing will be performed by the central lab and residual samples will be stored. The central lab will report both the qualitative results for each sample, i.e., positive or negative for COVID-19, and the cycle threshold (Ct) value for all positive samples.
- Conditions
- COVID-19
- Being tested
- CareSuperb COVID-19 Antigen Home Test Kit
- Keywords
- SARS-CoV-2, COVID-19, Home Test
- 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.
Positive percent agreement with sensitivity
Compare the positive result between CareSuperb COVID-19 Ag Home Test and three RT-PCR comparators.
Measured: within two weeks of study enrollment
Negative percent agreement with specificity
Compare the negative result between CareSuperb COVID-19 Ag Home Test and three RT-PCR comparators.
Measured: within two weeks of study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start9 Jan 2023
- Primary completion11 May 2023
- Study completion11 May 2023
Why it stopped: Cancel study
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
- Single group
- Model description
- This is an open label, prospective, randomized clinical agreement study to evaluate the sensitivity and specificity of the CareSuperb™ COVID-19 Antigen Home Test when a lay person conducts the test on themselves, or another study participant, as compared to EUA authorized high sensitivity RT-PCR comparator tests.
- Masking
- None (open label)
- Enrolment
- 786 participants (actual)
Sponsor and investigators
- Lead sponsor
- AccessBio, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyeonsuk Kim, Study director, Access Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771714
- Sponsor's protocol ID
- CT-22255-PR
- Status last verified
- Jul 2023
- First submitted
- 14 Mar 2023
- Last updated
- 13 Jul 2023
- 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 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Evaluation of the CareSuperb™ COVID-19 Antigen Home Test
- ClinicalTrials.gov ID
- NCT05771714
- Acronym / sponsor ID
- CT-22255-PR
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, COVID-19, Home Test
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Cancel study
- Enrolment
- 786 participants (actual)
- Lead sponsor
- AccessBio, Inc.University, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 16 Mar 2023 (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 accuracy of the CareSuperb™ COVID-19 Antigen Home Test (sensitivity and specificity) in a simulated home use environment when compared to the Roche cobas SARS-CoV-2 (EUA200009), Hologic Panther Fusion SARS-CoV-2 (EUA200014), and Roche cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (EUA210388) high sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assays.
Detailed description
This is an open label, prospective, randomized clinical agreement study to evaluate the sensitivity and specificity of the CareSuperb™ COVID-19 Antigen Home Test when a lay person conducts the test on themselves, or another study participant, as compared to EUA authorized high sensitivity RT-PCR comparator tests.
Patients presenting to the study site for COVID-19 testing who have signed the informed consent and assent, if applicable, and who meet the eligibility criteria will be enrolled in the study. Upon enrollment, the subject will be assigned a unique subject identification (ID) number. After obtaining relevant demographic and medical information, testing will ensue.
The first sample, collected by the clinical research staff, will be for the standard of care (SOC). Results of the SOC test will be used for subject treatment and management. To mitigate any potential bias which may affect the subject's visual interpretation of the CareSuperb™ test result, the study staff will not provide the SOC test results to the subject until after the results of the CareSuperb™ test are read by the subject.
There will be a 15-minute minimum wait period prior to the collection of the second anterior nares swab sample and an additional 15-minute minimum wait period between the second and third sample collection.
For Even numbered subjects, the second sample, collected by a study staff member, will be used for the RT-PCR comparator tests. The third sample will be collected and tested by the lay user, using the CareSuperb™ COVID-19 Antigen Home Test.
For Odd numbered subjects, the second sample will be collected and tested by the lay user using the CareSuperb™ COVID-19 Antigen Home Test. The third sample will be collected by a study staff member and will be used for the RT-PCR comparator tests.
The clinical study staff member will photograph each subject's test cartridge, labeled with their corresponding subject ID number. Additionally, the study staff member will record whether or not they agree with the test result's interpretation by the subject, and if not, why.
The RT-PCR sample will be placed in the provided viral transport medium (VTM) vial and stored in a -70°C freezer until ready for shipment to the central lab.
The comparator samples for RT-PCR testing will be shipped to the central lab weekly, unless directed otherwise by either the sponsor or the Clinical Research Organization (CRO). Specimens should be shipped on dry ice for next day delivery, avoiding weekend delivery. RT-PCR testing will be performed by the central lab and residual samples will be stored. The central lab will report both the qualitative results for each sample, i.e., positive or negative for COVID-19, and the cycle threshold (Ct) value for all positive samples.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open label, prospective, randomized clinical agreement study to evaluate the sensitivity and specificity of the CareSuperb™ COVID-19 Antigen Home Test when a lay person conducts the test on themselves, or another study participant, as compared to EUA authorized high sensitivity RT-PCR comparator tests.
| 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 (5 listed)
- An Institutional Review Board (IRB) approved informed consent and assent (if applicable) is signed and dated prior to any study related activities.
- Male and female subjects 2 years of age and older, presenting to the site seeking COVID-19 testing. If symptomatic, symptom onset must be within 5 days of enrollment into the study.
- 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 lay user.)
- Subject is willing to have nasal swabs collected by a member of the study staff.
- Subject agrees to complete all aspects of the study.
Key exclusion criteria (11 listed)
- Subject is undergoing treatment currently and/or within the past 30 days of study enrollment with medication to treat SARS-CoV-2, which may include but is not limited to Paxlovid, Remdesivir.
- Subject is receiving convalescent plasma therapy for SARS-CoV-2.
- Subject used a nasal wash or nasal aspirate treatment on enrollment day.
- Subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic treatment or therapy, or drug.
- Subjects who report or whose clinical status or history indicates that they take biotin >10 mg per day.
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
Positive percent agreement with sensitivity
Time frame: within two weeks of study enrollment
Compare the positive result between CareSuperb COVID-19 Ag Home Test and three RT-PCR comparators.
Negative percent agreement with specificity
Time frame: within two weeks of study enrollment
Compare the negative result between CareSuperb COVID-19 Ag Home Test and three RT-PCR comparators.
Results and safety
The study was stopped early (reason given: Cancel study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Hyeonsuk Kim study director
Access Bio
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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 13 Jul 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 was stopped early (reason given: Cancel 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?
Positive percent agreement with sensitivity (time frame: within two weeks of study enrollment). 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 13 Jul 2023.