Repeated Employee Testing for Understanding Our Recovery to Normal (RETURN)

The purpose of this research study is 1) to conduct a prospective longitudinal surveillance research trial, enrolling up to 200 CCHMC employees as they come back to work, and then following their clinical and laboratory parameters for up to 12 months; and 2) to support the ongoing development of diagnostic techniques for COVID-19. The overall goal is to investigate patterns of SARS-COV-2 infection, including immunological recovery and genetic risk factors, among CCHMC employees to better understand how to safely reintroduce the CCHMC work force back into their normal routines.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Diagnostic test: SARS-CoV-2

Detailed Description

As the global and pandemic spread of the novel coronavirus (SARS-CoV-2, COVID-19) continues, many knowledge gaps remain with regard to the epidemiology and transmission of infection, as well as the normal immunological responses after viral exposure. Cincinnati only recently (March 14, 2020) had its first confirmed case of COVID-19, and through shelter-in-place and social distancing efforts, has avoided the community spread experienced by some other large metropolitan areas. As investigators contemplate the gradual reintroduction of the Cincinnati Children's Hospital Medical Center (CCHMC) workforce back into the hospital, it is imperative that investigators determine the current prevalence of infection among CCHMC employees, measure the cumulative incidence of infection over the next 12 months, investigate the normal antibody patterns after infection, and help elucidate what constitutes a protective immunological response. Investigators have a unique but time-limited opportunity to optimally track the epidemiology and natural history of SARS-CoV-2 infection at CCHMC, including risk factors for transmission and immunological recovery. RETURN will investigate epidemiological and immunological features of SARS-CoV-2 virus infection in a limited cohort of CCHMC employees, as they return from the current shelter-at-home directive toward a normal work environment. By collecting and analyzing weekly serial samples for SARS-CoV-2 (nasal swab for virus by PCR) and monthly serological exposure (serum antibodies by ELISA), investigators will determine the prevalence and cumulative incidence of exposure to SARS-CoV-2; document the antibody responses over time; identify cases of apparent viral recrudescence or re-infection; and create models of transmission risk among CCHMC employees.

• Study Type: Observational
• Enrollment (Actual): 236

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult men and women who are employed full time at Cincinnati Children's Hospital.

Description

Inclusion Criteria:

• Current full-time employees at Cincinnati Children's Hospital
• Age: >18.0 years of age, at the time of enrollment
• Cell phone that can be used for text messaging or web-based viewing of surveys
• Willing and able to provide informed consent
• Ability to comply with all study related evaluations and follow-up

Exclusion Criteria:

• Previous proven SARS-CoV-2 infection (positive PCR-based molecular test)
• Any condition or illness that makes study participation ill-advised
• Currently or planning to enroll in a COVID-19 vaccine or prophylaxis study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Full-Time CCHMC Employees	Diagnostic test: SARS-CoV-2; Testing weekly samples from nasal swabs to promptly diagnose acute COVID-19 infection.; Testing monthly serum samples to document post-viral infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The 6-month cumulative incidence of acquired COVID infection in the study cohort.	Acquired COVID is defined as testing negative for COVID at baseline and having 1 or more weekly nasal swab samples testing positive for the virus by PCR	Weekly for 6 months

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Russell Ware, MD, PhD, Children's Hospital Medical Center, Cincinnati; Principal Investigator: Mary Allen Staat, MD, MPH, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: RETURN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No