COVID-19 Respiratory InfectionNCT04959760
BinaxNow COVID-19 IgG Rapid Test Device and Antibody Self Test
A study testing The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2. in people with COVID-19 Respiratory Infection, run by Abbott Rapid Diagnostics Jena GmbH at 5 sites in United States.
Trial summary
Performance evaluation of the BinaxNOW™ COVID-19 IgG Rapid Test Device (Professional Use) and with BinaxNOW™ COVID-19 Antibody Self Test wehn used with fingerstick capillary whole blood and plasma samples. The BinaxNOW™ Antibody Tests are lateral flow tests that measure SARS-CoV-2 IgG antibodies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Respiratory Infection
- What is being tested?
- The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 5 sitesUnited States
- Study dates
- 3 Jun 2021to 20 Jan 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is 18 years of age or older.
- Evaluable individuals with a prior confirmed SARS-CoV-2 infection with prior COVID-19 symptoms with symptoms onset > 14 days prior to the study, or symptoms onset 8-14 days prior to the study, or symptoms onset 0-7 days prior to study.OR
- Evaluable individuals confirmed negative by SARS-CoV-2 RT-PCR using a sample obtained within 7 days prior to or on the day of the study.
- Participant agrees to complete all aspects of the study.
Who cannot join
- Participant has already participated in this study on a previous occasion.
- Participant is enrolled in a study to evaluate a new drug.
- Participant has a visual impairment that cannot be restored using glasses or contact lenses.
- Participant is unable or unwilling to provide informed consent.
- Participant is a vulnerable person as deemed unfit for the study by the Principal Investigator.
- Participant has a condition deemed unfit to safely perform the test by the investigator.
- Participant is a practising health-care professional or laboratory scientist / technician.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Rush University Medical Center
Chicago, Illinois, 60612
Urgent Care Clinical Trials
Dallas, Texas, 75204
Duke University Health System
Durham, North Carolina, 27705
Urgent Care Clinical Trials at Complete Health Partners
Nashville, Tennessee, 37209
Urgent Care Clinical Trials
Powdersville, South Carolina, 29611
About this study
Official title: Clinical Evaluation of the BinaxNOW™ COVID-19 IgG Rapid Test Device and the BinaxNOW™ COVID-19 Antibody Self Test Clinical Study Protocol
Performance evaluation of the BinaxNOW™ COVID-19 IgG Rapid Test Device (Professional Use) and with BinaxNOW™ COVID-19 Antibody Self Test wehn used with fingerstick capillary whole blood and plasma samples. The BinaxNOW™ Antibody Tests are lateral flow tests that measure SARS-CoV-2 IgG antibodies.
- Conditions
- COVID-19 Respiratory Infection
- Being tested
- The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2.Diagnostic test
The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2 in fingestick capillary blood and plasma samples.
| Study group | Role | What they receive |
|---|---|---|
| BinaxNow Covid-19 Antibody test | Experimental | The BinaxNOW™ Antibody Tests measure SARS-CoV-2 S-IgG antibodies. Receives: Diagnostic Test: The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test
to evaluate the clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test Device when used by a professional user.
Measured: Through study completion, an average of 6 months
Clinical performance of the BinaxNOW™ COVID-19 Antibody Self-Test
to evaluate the clinical performance of the BinaxNOW™ COVID-19 Antibody Self-Test when used by a lay person.
Measured: Through study completion, an average of 6 months
Secondary outcomes (4)
Professional user usability
Evaluation of the usability of the BinaxNOW™ COVID-19 IgG Rapid Test Device when used by a Professional User
Measured: Through study completion, an average of 6 months
Self Test user usability
Evaluation of the usability of the BinaxNOW™ COVID-19 Antibody Self-Test when used by a lay person.
Measured: Through study completion, an average of 6 months
Matrix Equivalence Professional Use
Validation of the Matrix Equivalence between the Fingerstick Whole Blood and Plasma samples when used with the BinaxNOW COVID-19 IgG Rapid Test Device.
Measured: Through study completion, an average of 6 months
Diagnostic sensitivity and specificity
To determine the diagnostic sensitivity, specificity and overall agreement of the BinaxNOW™ COVID-19 Antibody Self Test as performed by lay users in comparison with the BinaxNOW™ COVID-19 IgG Rapid Test Device as performed by professional user.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start3 Jun 2021
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Rapid Diagnostics Jena GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simon Kordowich, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959760
- Sponsor's protocol ID
- CLDG-0511
- Status last verified
- May 2022
- First submitted
- 1 Jul 2021
- Last updated
- 9 May 2022
- 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 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the BinaxNOW™ COVID-19 IgG Rapid Test Device and the BinaxNOW™ COVID-19 Antibody Self Test Clinical Study Protocol
- ClinicalTrials.gov ID
- NCT04959760
- Acronym / sponsor ID
- CLDG-0511
- Conditions
- COVID-19 Respiratory Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Abbott Rapid Diagnostics Jena GmbHIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 13 Jul 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.
Performance evaluation of the BinaxNOW™ COVID-19 IgG Rapid Test Device (Professional Use) and with BinaxNOW™ COVID-19 Antibody Self Test wehn used with fingerstick capillary whole blood and plasma samples. The BinaxNOW™ Antibody Tests are lateral flow tests that measure SARS-CoV-2 IgG antibodies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BinaxNow Covid-19 Antibody test | Experimental | Diagnostic Test: The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2.The BinaxNOW™ Antibody Tests measure SARS-CoV-2 S-IgG antibodies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant is 18 years of age or older.
- Evaluable individuals with a prior confirmed SARS-CoV-2 infection with prior COVID-19 symptoms with symptoms onset > 14 days prior to the study, or symptoms onset 8-14 days prior to the study, or symptoms onset 0-7 days prior to study.OR
- Evaluable individuals confirmed negative by SARS-CoV-2 RT-PCR using a sample obtained within 7 days prior to or on the day of the study.
- Participant agrees to complete all aspects of the study.
Key exclusion criteria (7 listed)
- Participant has already participated in this study on a previous occasion.
- Participant is enrolled in a study to evaluate a new drug.
- Participant has a visual impairment that cannot be restored using glasses or contact lenses.
- Participant is unable or unwilling to provide informed consent.
- Participant is a vulnerable person as deemed unfit for the study by the Principal Investigator.
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 |
|---|---|---|
| The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2.The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2 in fingestick capillary blood and plasma samples. | Diagnostic test | BinaxNow Covid-19 Antibody test |
Primary outcome
Clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test
Time frame: Through study completion, an average of 6 months
to evaluate the clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test Device when used by a professional user.
Clinical performance of the BinaxNOW™ COVID-19 Antibody Self-Test
Time frame: Through study completion, an average of 6 months
to evaluate the clinical performance of the BinaxNOW™ COVID-19 Antibody Self-Test when used by a lay person.
4 secondary outcomes
Professional user usability
Time frame: Through study completion, an average of 6 months
Self Test user usability
Time frame: Through study completion, an average of 6 months
Matrix Equivalence Professional Use
Time frame: Through study completion, an average of 6 months
Diagnostic sensitivity and specificity
Time frame: Through study completion, an average of 6 months
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 9 May 2022.
- 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.
Simon Kordowich study director
Abbott
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2. in people with COVID-19 Respiratory Infection, run by Abbott Rapid Diagnostics Jena GmbH at 5 sites 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 7 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 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test (time frame: Through study completion, an average of 6 months). 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 9 May 2022.