Repeated Employee Testing for Understanding Our Recovery to Normal

COVID-19 Clinical Trial

— RETURN  

Official title:

Repeated Employee Testing for Understanding Our Recovery to Normal

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04472793
• Other study ID #: RETURN
• Status: Active, not recruiting
• Start date: May 11, 2020
• Est. completion date: December 2023

Study information

• Verified date: July 2022
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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