Clinical trial NCT04805840: Sensitivity of Frequent SARS-CoV-2 (COVID-19) Rapid Antigen Testing Regimen
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Covid19
Keywords: COVID-19
COVID
Coronavirus
SARS-CoV-2
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Employees and cast members of a Media and Entertainment Company

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

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

Primary outcomes:
measure: Sensitivity of CoV-SCAN daily testing regimen
timeFrame: Baseline to 21 days
measure: Specificity of CoV-SCAN daily testing regimen
timeFrame: Baseline to 21 days
Secondary outcomes:
measure: Time from CoV-SCAN positive to PCR positive result
timeFrame: Baseline to 21 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Assistant Professor
name: Kathrine Meyers, DrPH, MS, MPP
role: PRINCIPAL_INVESTIGATOR
References: