Covid19NCT04805840
Sensitivity of Frequent SARS-CoV-2 (COVID-19) Rapid Antigen Testing Regimen
An observational study of Covid19, run by Columbia University at 1 site in United States.
Trial summary
This study aims to assess how an at-home COVID-19 frequent testing regimen using the CoV-SCAN test kit and a paired phone application to help interpret the test result compares to once-a-week or three-times-a-week polymerase chain reaction (PCR) (molecular) testing to identify a SARS-CoV-2 infection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- CoV-SCAN rapid COVID-19 antigen test
- Type of treatment
- Medical device
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2021to 14 Jul 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Employees and cast members of a Media and Entertainment Company
Who may be able to join
- Aged 18 years or older;
- Have a smartphone;
- Understand and read English;
- Will be on one production location for at least three weeks following enrollment to the study;
- Will be willing to be contacted by the Study Coordinator after leaving one production location to facilitate continued access to weekly molecular testing;
Who cannot join
- Have received any dose of COVID-19 vaccination;
- Have been diagnosed with COVID-19 infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Comparison of Screening for SARS-CoV-2 (COVID-19) in a Low Prevalence Setting Using Serial Antigen Testing Versus Serial Molecular (PCR) Testing
This study aims to assess how an at-home COVID-19 frequent testing regimen using the CoV-SCAN test kit and a paired phone application to help interpret the test result compares to once-a-week or three-times-a-week polymerase chain reaction (PCR) (molecular) testing to identify a SARS-CoV-2 infection.
Employees and cast members at Media and Entertainment Company and its affiliates will be recruited to test whether frequent use of CoV-SCAN will perform as well or better than weekly molecular testing and at least as well as three-times-a-week molecular testing.
Read the detailed description
Antigen tests are simple to perform, have a rapid turn-around time of 15-30 minutes, and a lower cost than molecular tests. Because antigen tests do not incorporate an amplification step, they are intrinsically less sensitive than PCR molecular tests. Nevertheless, several investigators have examined the feasibility of screening populations of individuals in a low SARS-CoV-2 infection prevalence situation, such as the workplace or schools, with rapid antigen tests in place of the molecular tests. Using viral kinetics, knowledge of what level of viral load is required for transmission of culture-competent virus, test sensitivity and modeling, they have come to the conclusion that more frequent testing with a test with lower sensitivity that has a quick turn-around time is better than a test with high sensitivity with a longer turn-around time. Therefore, the goal of this study is to test the hypothesis that frequent testing with a relatively sensitive lateral flow antigen test performed at home using self-collected anterior nasal swabs will be superior to once a week or less PCR testing and non-inferior to three times a week PCR testing in an employment screening setting with a relatively low incidence of new SARS-CoV-2 infections. This study aims to assess how an at-home COVID-19 frequent testing regimen using a Rapid Antigen Screening Test (RAST) and a phone application to help interpret the test result compares to once-a-week or three-times-a-week PCR (molecular) testing to identify a SARS-CoV-2 infection. We expect to recruit up to 4,400 employees and cast members of Media and Entertainment Company and its affiliates to test whether frequent use of the RAST will perform as well or better than weekly molecular testing and at least as well as three-times-a-week molecular testing. Recruitment and the study will continue until at least 31 or at most 148 true positive SARS-CoV-2 molecular results are reached.
- Conditions
- Covid19
- Being tested
- CoV-SCAN rapid COVID-19 antigen test
- Keywords
- COVID-19, COVID, Coronavirus, SARS-CoV-2
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoV-SCAN rapid COVID-19 antigen testDevice
SARS-CoV-2 rapid antigen screening test
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of CoV-SCAN daily testing regimen
To compare the sensitivity (the percentage of people with the disease who test positive) of the rapid antigen testing regimen to the gold standard PCR testing regimen
Measured: Baseline to 21 days
Specificity of CoV-SCAN daily testing regimen
To compare the specificity (the ability of the test to correctly identify those without the disease) of the rapid antigen testing regimen to the gold standard PCR testing regimen
Measured: Baseline to 21 days
Secondary outcomes (1)
Time from CoV-SCAN positive to PCR positive result
To compare time to diagnosis with the rapid antigen testing regimen to the gold standard PCR testing regimen
Measured: Baseline to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start19 Feb 2021
- Primary completion2 Jun 2021
- Study completion14 Jul 2021
Why it stopped: Difficulty with recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathrine Meyers, DrPH, MS, MPP, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805840
- Sponsor's protocol ID
- AAAT5233
- Status last verified
- Nov 2021
- First submitted
- 17 Mar 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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
- Comparison of Screening for SARS-CoV-2 (COVID-19) in a Low Prevalence Setting Using Serial Antigen Testing Versus Serial Molecular (PCR) Testing
- ClinicalTrials.gov ID
- NCT04805840
- Acronym / sponsor ID
- AAAT5233
- Conditions
- Covid19
- Keywords
- COVID-19, COVID, Coronavirus, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty with recruitment.
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 14 Jul 2021 (actual)
- First posted
- 18 Mar 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.
This study aims to assess how an at-home COVID-19 frequent testing regimen using the CoV-SCAN test kit and a paired phone application to help interpret the test result compares to once-a-week or three-times-a-week polymerase chain reaction (PCR) (molecular) testing to identify a SARS-CoV-2 infection.
Employees and cast members at Media and Entertainment Company and its affiliates will be recruited to test whether frequent use of CoV-SCAN will perform as well or better than weekly molecular testing and at least as well as three-times-a-week molecular testing.
Detailed description
Antigen tests are simple to perform, have a rapid turn-around time of 15-30 minutes, and a lower cost than molecular tests. Because antigen tests do not incorporate an amplification step, they are intrinsically less sensitive than PCR molecular tests. Nevertheless, several investigators have examined the feasibility of screening populations of individuals in a low SARS-CoV-2 infection prevalence situation, such as the workplace or schools, with rapid antigen tests in place of the molecular tests. Using viral kinetics, knowledge of what level of viral load is required for transmission of culture-competent virus, test sensitivity and modeling, they have come to the conclusion that more frequent testing with a test with lower sensitivity that has a quick turn-around time is better than a test with high sensitivity with a longer turn-around time. Therefore, the goal of this study is to test the hypothesis that frequent testing with a relatively sensitive lateral flow antigen test performed at home using self-collected anterior nasal swabs will be superior to once a week or less PCR testing and non-inferior to three times a week PCR testing in an employment screening setting with a relatively low incidence of new SARS-CoV-2 infections. This study aims to assess how an at-home COVID-19 frequent testing regimen using a Rapid Antigen Screening Test (RAST) and a phone application to help interpret the test result compares to once-a-week or three-times-a-week PCR (molecular) testing to identify a SARS-CoV-2 infection. We expect to recruit up to 4,400 employees and cast members of Media and Entertainment Company and its affiliates to test whether frequent use of the RAST will perform as well or better than weekly molecular testing and at least as well as three-times-a-week molecular testing. Recruitment and the study will continue until at least 31 or at most 148 true positive SARS-CoV-2 molecular results are reached.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Employees and cast members of a Media and Entertainment Company
Key inclusion criteria (5 listed)
- Aged 18 years or older;
- Have a smartphone;
- Understand and read English;
- Will be on one production location for at least three weeks following enrollment to the study;
- Will be willing to be contacted by the Study Coordinator after leaving one production location to facilitate continued access to weekly molecular testing;
Key exclusion criteria (2 listed)
- Have received any dose of COVID-19 vaccination;
- Have been diagnosed with COVID-19 infection.
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 |
|---|---|---|
| CoV-SCAN rapid COVID-19 antigen testSARS-CoV-2 rapid antigen screening test | Device | – |
Primary outcome
Sensitivity of CoV-SCAN daily testing regimen
Time frame: Baseline to 21 days
To compare the sensitivity (the percentage of people with the disease who test positive) of the rapid antigen testing regimen to the gold standard PCR testing regimen
Specificity of CoV-SCAN daily testing regimen
Time frame: Baseline to 21 days
To compare the specificity (the ability of the test to correctly identify those without the disease) of the rapid antigen testing regimen to the gold standard PCR testing regimen
1 secondary outcome
Time from CoV-SCAN positive to PCR positive result
Time frame: Baseline to 21 days
Results and safety
The study was stopped early (reason given: Difficulty with recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
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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.
Kathrine Meyers, DrPH, MS, MPP principal investigator
Assistant Professor
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 Covid19, run by Columbia University 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 2 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 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?
The study was stopped early (reason given: Difficulty with recruitment.). 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 of CoV-SCAN daily testing regimen (time frame: Baseline to 21 days). 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.