Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04508777 |
| Other study ID # |
843565-OBS |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 9, 2020 |
| Est. completion date |
June 23, 2021 |
Study information
| Verified date |
February 2022 |
| Source |
University of Pennsylvania |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
In order to safely and effectively reopen businesses and universities across the US,
institutions will need to develop approaches to rapidly identify COVID-19 cases and manage
their spread while balancing program effectiveness, feasibility, costs, and scalability.
This study will evaluate the implementation of a COVID-19 screening program that coordinates
several existing systems at the University of Pennsylvania including saliva-based viral
testing.
Description:
The coronavirus disease 2019 (COVID-19) pandemic has resulted in close to 10,000,000 reported
cases worldwide, including more than 2,000,000 aggregated reported cases and 120,000 deaths
in the United States. Initial efforts to address the COVID-19 pandemic were aimed at testing
symptomatic individuals, implementing stay-in-place orders, and at increasing hospital
capacity to meet surge demands. While nations continue to confront the current crisis, plans
for the future must be put in place tools to enhance our ability to conduct effective
screening, containment, and case management.
Widespread COVID-19 testing is needed to safely and effectively reopen schools and businesses
across the US. However, currently approved testing options require reagents that are limited
in supply, severely hindering scalability. Emerging evidence indicates that saliva testing
with the option of at-home sample collection can accurately identify COVID-19 viral
infection. Additional diagnostic testing options will continue to increase patient access.
Moreover, this approach provides an option for the easy, safe and convenient collection of
samples required for testing without traveling to a doctor's office, hospital, or testing
site. Collection by the patient also reduces exposure of health care workers to the virus and
preserves limited personal protective equipment.
With access to expanded testing, health systems and universities will need to test
alternative methods to manage COVID-19 spread while balancing program effectiveness,
feasibility, costs, and scalability. Insights from the field of behavioral economics offer
promise for designing and sustaining these kinds of policies. For these reasons, the
investigators propose to evaluate the implementation of a COVID-19 screening program that
uses saliva-based testing.
