SARS-CoV2 InfectionNCT06452056
COVID-19 SARS-CoV-2 RAST Study
An observational study of SARS-CoV2 Infection, run by Columbia University at 1 site in United States.
Trial summary
The SARS-CoV-2 BioMedomics Rapid Antigen Screening Test (COV-SCAN) is an at-home rapid antigen COVID-19 antigen screening test device. The primary objectives of this study are to 1) Evaluate the clinical performance of COV-SCAN; 2.) Assess the usability of COV-SCAN and the paired app as an over-the-counter product to… Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV2 Infection
- What is being tested?
- Rapid Antigen Screening Test
- Type of treatment
- Medical device
- How many people
- 337 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2021to 30 Dec 2022
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Clinical Evaluation and Human Usability: Participants will be of varying education levels, race/ethnicities, genders and health statuses. Demonstration: Participants will be undergraduate students housed on Columbia University campus and graduate students living in Columbia Residential properties. CUIMC residential housing will not be included.
Who may be able to join
- Demonstration segment:
- Confirmed age of 18 years or older
- Current Columbia University student, matriculating through Spring 2020 (either undergraduate or graduate)
- Affiliated with Columbia throughout study observation period and willingness to provide consent
Who cannot join
- Clinical Evaluation segment:
- Those unable or unwilling to provide consent to all aspects of the study
- Those who do not have the ability to speak and comprehend English or Spanish
- Human Usability segment:
- Those with prior experience with self-collection or self-testing prior to COVID-19
- Those with prior medical or laboratory training
Show all 13Show fewer
- Those unable or unwilling to provide consent to all aspects of the study
- Those who do not have the ability to speak and comprehend English or Spanish
- Demonstration segment:
- Unable or unwilling to provide consent to all aspects of the study
- Any participant who will not be remaining affiliated with Columbia University for the duration of the study
- Students who do not have the ability to speak and comprehend English or Spanish
- Students who do not own a smartphone.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: SARS-CoV-2 Rapid Antigen Screening Test Validation, Usability, and Demonstration Study
The SARS-CoV-2 BioMedomics Rapid Antigen Screening Test (COV-SCAN) is an at-home rapid antigen COVID-19 antigen screening test device. The primary objectives of this study are to 1) Evaluate the clinical performance of COV-SCAN; 2.) Assess the usability of COV-SCAN and the paired app as an over-the-counter product to be used by lay persons in non- laboratory settings. The clinical performance and usability data will be submitted as part of an application for Emergency Use Authorization (EUA) to the FDA. 3) Assess acceptability and feasibility of the COV-SCAN test, paired app, and frequent testing regimen in demonstration projects in university and workforce settings.
Read the detailed description
The study will be divided into three segments 1) Clinical Evaluation; 2) Human Usability; 3) Demonstration. The design of each of these is described below.
- Clinical Evaluation Study: The Clinical Evaluation Study will use standard methods for assessing clinical agreement between the assay we are testing and comparator molecular assay that already has EUA. Below, we provide greater detail on the methods and activities within each component of the process, and then provide an explanation of our analytic plan and approach.
- Human Usability Study: The Human Usability Study will be conducted using clinical ethnographic methods of observation, semi-structured interviews, and survey review. In implementation science, clinical ethnography has been used as a way to understand processes by which interventions are delivered (including barriers and facilitators) as well as fidelity to a given intervention model. Observation may be in person or via video conferencing.
- Demonstration Project:
Our demonstration project in the Columbia University community will offer COV-SCAN and paired app to undergraduate students housed on the Columbia campus and to graduate students living in Columbia-owned residences on the Morningside campus. Currently, undergraduate students living on campus are required to get a weekly molecular based test administered by Columbia Health through a surveillance testing site. Graduate students are currently not required to routinely test, though maybe selected through a random sample for testing, or may access testing voluntarily. They are required to do symptom attestation through the ReOpen CU app in order to enter campus buildings. Through recruitment methods detailed below, students will be invited to participate in the study. Participation will entail every-other-day testing using the COV-SCAN kit and paired app for a three month period and reporting on usability, acceptability, and feasibility at timepoints.
- Conditions
- SARS-CoV2 Infection
- Being tested
- Rapid Antigen Screening 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.
Rapid Antigen Screening TestDevice
A point-of-care Rapid Antigen Screening Test (RAST) using a lateral flow immunoassay platform with our partner, BioMedomics Inc. The BioMedomics RAST is a lateral flow immunoassay that detects the nucleocapsid protein (NP) antigen of SARS-CoV-2 using a double antibody sandwich assay. The test cassette contains one detection line (T) fixed with anti-SARS-CoV-2 NP antibody and one quality control line (C) fixed with control antibody. When the test sample is treated with lysis buffer and added to the sample well of the test cassette, the fluid will move forward along the test strip via capillary action. If the sample contains NP antigen at levels higher than the limit of detection, the antigen will bind to the NP capture antibody as well as the immobilized detection antibody on the membrane forming a red T line, indicating a positive result. A positive signal at C line provides assurance that the fluid containing the sample material has moved laterally in an appropriate fashion.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Evaluation | Participants (N=170) will be divided into three categories: known to be COVID+ symptomatic (n=50); known to be COVID+ asymptomatic (n=20) and not known to have COVID n=100 Receives: Device: Rapid Antigen Screening Test | |
| Human Usability | Participants not known to have COVID (n=180) will be observed by a trained observer either in person or by videomonitoring when performed in non laboratory, actual or simulated use environments.
We will split our usability study into two sections including participants testing themselves (n=90) and participants testing another person (child or adult) (n=90). Receives: Device: Rapid Antigen Screening Test | |
| Demonstration Project | Our demonstration project in the Columbia University community will offer COV-SCAN and paired app to undergraduate students housed on the Columbia campus and to graduate students living in Columbia-owned residences on the Morningside campus. Receives: Device: Rapid Antigen Screening Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Evaluation of COV-SCAN
Evaluate the clinical performance of COV-SCAN; Determine the accuracy of the COV-SCAN test compared to the RT-PCR test.
Measured: 1 year
Usability of COV-SCAN
The usability of COV-SCAN will be analyzed using the Systems Usability Scale (SUS). The SUS is a validated, 10-item questionnaire with a 5-point Likert scale (1="strongly disagree" to 5="strongly agree"). The distribution of responses to each of the ten items will be visualized and summarized. Using standard scoring methodology, a SUS score ranging from 0 to 100 will be calculated, with a higher score indicating higher usability. The study will average individual SUS scores to obtain an average SUS score across study participants.
Measured: 2 years
Feasibility of COV-SCAN
Feasibility will be measured by the Acceptability of Intervention Measure (AIM), a four-item validated measure of perceived intervention acceptability with items scored from "Completely Disagree" to "Completely Agree" on a 5-point Likert scale. A higher score indicates higher feasibility.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start7 Jan 2021
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 InfectionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Yin, MD, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452056
- Sponsor's protocol ID
- AAAT4238
- Status last verified
- Jun 2024
- First submitted
- 30 May 2024
- Last updated
- 11 Jun 2024
- 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 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 Rapid Antigen Screening Test Validation, Usability, and Demonstration Study
- ClinicalTrials.gov ID
- NCT06452056
- Acronym / sponsor ID
- AAAT4238
- Conditions
- SARS-CoV2 Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 11 Jun 2024 (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 SARS-CoV-2 BioMedomics Rapid Antigen Screening Test (COV-SCAN) is an at-home rapid antigen COVID-19 antigen screening test device. The primary objectives of this study are to 1) Evaluate the clinical performance of COV-SCAN; 2.) Assess the usability of COV-SCAN and the paired app as an over-the-counter product to be used by lay persons in non- laboratory settings. The clinical performance and usability data will be submitted as part of an application for Emergency Use Authorization (EUA) to the FDA. 3) Assess acceptability and feasibility of the COV-SCAN test, paired app, and frequent testing regimen in demonstration projects in university and workforce settings.
Detailed description
The study will be divided into three segments 1) Clinical Evaluation; 2) Human Usability; 3) Demonstration. The design of each of these is described below.
- Clinical Evaluation Study: The Clinical Evaluation Study will use standard methods for assessing clinical agreement between the assay we are testing and comparator molecular assay that already has EUA. Below, we provide greater detail on the methods and activities within each component of the process, and then provide an explanation of our analytic plan and approach.
- Human Usability Study: The Human Usability Study will be conducted using clinical ethnographic methods of observation, semi-structured interviews, and survey review. In implementation science, clinical ethnography has been used as a way to understand processes by which interventions are delivered (including barriers and facilitators) as well as fidelity to a given intervention model. Observation may be in person or via video conferencing.
- Demonstration Project:
Our demonstration project in the Columbia University community will offer COV-SCAN and paired app to undergraduate students housed on the Columbia campus and to graduate students living in Columbia-owned residences on the Morningside campus. Currently, undergraduate students living on campus are required to get a weekly molecular based test administered by Columbia Health through a surveillance testing site. Graduate students are currently not required to routinely test, though maybe selected through a random sample for testing, or may access testing voluntarily. They are required to do symptom attestation through the ReOpen CU app in order to enter campus buildings. Through recruitment methods detailed below, students will be invited to participate in the study. Participation will entail every-other-day testing using the COV-SCAN kit and paired app for a three month period and reporting on usability, acceptability, and feasibility at timepoints.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinical Evaluation | – | Device: Rapid Antigen Screening TestParticipants (N=170) will be divided into three categories: known to be COVID+ symptomatic (n=50); known to be COVID+ asymptomatic (n=20) and not known to have COVID n=100 |
| Human Usability | – | Device: Rapid Antigen Screening TestParticipants not known to have COVID (n=180) will be observed by a trained observer either in person or by videomonitoring when performed in non laboratory, actual or simulated use environments. We will split our usability study into two sections including participants testing themselves (n=90) and participants testing another person (child or adult) (n=90). |
| Demonstration Project | – | Device: Rapid Antigen Screening TestOur demonstration project in the Columbia University community will offer COV-SCAN and paired app to undergraduate students housed on the Columbia campus and to graduate students living in Columbia-owned residences on the Morningside campus. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clinical Evaluation and Human Usability: Participants will be of varying education levels, race/ethnicities, genders and health statuses. Demonstration: Participants will be undergraduate students housed on Columbia University campus and graduate students living in Columbia Residential properties. CUIMC residential housing will not be included.
Key inclusion criteria (4 listed)
- Confirmed age of 18 years or older
- Current Columbia University student, matriculating through Spring 2020 (either undergraduate or graduate)
- Affiliated with Columbia throughout study observation period and willingness to provide consent
Key exclusion criteria (13 listed)
- Those unable or unwilling to provide consent to all aspects of the study
- Those who do not have the ability to speak and comprehend English or Spanish
- Those with prior experience with self-collection or self-testing prior to COVID-19
- Those with prior medical or laboratory training
- Those unable or unwilling to provide consent to all aspects of the study
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 |
|---|---|---|
| Rapid Antigen Screening TestA point-of-care Rapid Antigen Screening Test (RAST) using a lateral flow immunoassay platform with our partner, BioMedomics Inc. The BioMedomics RAST is a lateral flow immunoassay that detects the nucleocapsid protein (NP) antigen of SARS-CoV-2 using a double antibody sandwich assay. The test cassette contains one detection line (T) fixed with anti-SARS-CoV-2 NP antibody and one quality control line (C) fixed with control antibody. When the test sample is treated with lysis buffer and added to the sample well of the test cassette, the fluid will move forward along the test strip via capillary action. If the sample contains NP antigen at levels higher than the limit of detection, the antigen will bind to the NP capture antibody as well as the immobilized detection antibody on the membrane forming a red T line, indicating a positive result. A positive signal at C line provides assurance that the fluid containing the sample material has moved laterally in an appropriate fashion. | Device | Clinical Evaluation, Demonstration Project, Human Usability |
Primary outcome
Clinical Evaluation of COV-SCAN
Time frame: 1 year
Evaluate the clinical performance of COV-SCAN; Determine the accuracy of the COV-SCAN test compared to the RT-PCR test.
Usability of COV-SCAN
Time frame: 2 years
The usability of COV-SCAN will be analyzed using the Systems Usability Scale (SUS). The SUS is a validated, 10-item questionnaire with a 5-point Likert scale (1="strongly disagree" to 5="strongly agree"). The distribution of responses to each of the ten items will be visualized and summarized. Using standard scoring methodology, a SUS score ranging from 0 to 100 will be calculated, with a higher score indicating higher usability. The study will average individual SUS scores to obtain an average SUS score across study participants.
Feasibility of COV-SCAN
Time frame: 2 years
Feasibility will be measured by the Acceptability of Intervention Measure (AIM), a four-item validated measure of perceived intervention acceptability with items scored from "Completely Disagree" to "Completely Agree" on a 5-point Likert scale. A higher score indicates higher feasibility.
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 11 Jun 2024.
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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.
Michael Yin, MD, MS principal investigator
Columbia University
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 SARS-CoV2 Infection, 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 4 inclusion and 13 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 11 Jun 2024. 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?
Clinical Evaluation of COV-SCAN (time frame: 1 year). The study lists 3 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 11 Jun 2024.