Sensitivity of Frequent SARS-CoV-2 (COVID-19) Rapid Antigen Testing Regimen

NCT04805840 | Terminated FDA Device

• 1 other identifier: AAAT5233
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Covid19

Keywords

COVID-19; COVID; Coronavirus; SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Baseline to 21 days

Secondary Outcomes (1)

• Time from CoV-SCAN positive to PCR positive result

  Baseline to 21 days

Interventions

CoV-SCAN rapid COVID-19 antigen test DEVICE

SARS-CoV-2 rapid antigen screening test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Employees and cast members of a Media and Entertainment Company

You may qualify if:

• 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;

You may not qualify if:

• Have received any dose of COVID-19 vaccination;
• Have been diagnosed with COVID-19 infection.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kathrine Meyers, DrPH, MS, MPP

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 18, 2021
• Study Start: February 19, 2021
• Primary Completion: June 2, 2021
• Study Completion: July 14, 2021
• Last Updated: November 18, 2021

Record last verified: 2021-11

Locations

US (1)