Repeated Employee Testing for Understanding Our Recovery to Normal

NCT04472793 | Completed

• 1 other identifier: RETURN
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Full-Time CCHMC Employees

Diagnostic Test: SARS-CoV-2

Interventions

SARS-CoV-2 DIAGNOSTIC_TEST

1. Testing weekly samples from nasal swabs to promptly diagnose acute COVID-19 infection. 2. Testing monthly serum samples to document post-viral infection.

Full-Time CCHMC Employees

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and DNA Samples

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Russell Ware, MD, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Mary Allen Staat, MD, MPH

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: July 15, 2020
• Study Start: May 11, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)