Clinical trial NCT06452056: COVID-19 SARS-CoV-2 RAST Study
Official title: SARS-CoV-2 Rapid Antigen Screening Test Validation, Usability, and Demonstration Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV2 Infection
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 337
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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
* 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.

Primary outcomes:
measure: Clinical Evaluation of COV-SCAN
timeFrame: 1 year
measure: Usability of COV-SCAN
timeFrame: 2 years
measure: Feasibility of COV-SCAN
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Michael Yin, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: