COVID SAFE: COVID-19 Screening Assessment for Exposure

NCT ID: NCT04508777

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1759 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-09
• Study Completion Date: 2021-06-23

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.

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.

Conditions

Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Saliva-based testing

Participants will take part in a voluntary COVID-19 screening program that includes bi-weekly saliva-based testing.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitesh S Patel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Penn Medicine

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

843565-OBS

Identifier Type: -

Identifier Source: org_study_id