COVID SAFE: COVID-19 Screening Assessment for Exposure

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT04508777
Collaborator
(none)
1,759
1
9.4
186.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Saliva-based testing

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
1759 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
COVID SAFE: COVID-19 Screening Assessment for Exposure
Actual Study Start Date :
Sep 9, 2020
Actual Primary Completion Date :
Dec 8, 2020
Actual Study Completion Date :
Jun 23, 2021

Outcome Measures

Primary Outcome Measures

  1. Test compliance [3 months]

    The rate of compliance with saliva-based testing

Other Outcome Measures

  1. Test compliance [6 months]

    The rate of compliance with saliva-based testing

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Be 18 years or older

  • University of Pennsylvania faculty, staff, or trainee

  • Have a phone or device capable of receiving text messages

  • Willing to participate in the study for 6 months

Exclusion Criteria:
  • Participants will not be eligible if they identify any reason they are unable to participate in the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Penn Medicine Philadelphia Pennsylvania United States 19103

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

  • Principal Investigator: Mitesh S Patel, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT04508777
Other Study ID Numbers:
  • 843565-OBS
First Posted:
Aug 11, 2020
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Pennsylvania
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022