Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452056
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2024-05-30
Brief Title:
COVID-19 SARS-CoV-2 RAST Study
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
SARS-CoV-2 Rapid Antigen Screening Test Validation Usability and Demonstration Study
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
1 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
2 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
3 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
1 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
2 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
3 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None