Repeated Employee Testing for Understanding Our Recovery to Normal

  • STATUS
    Recruiting
  • participants needed
    200
  • sponsor
    Children's Hospital Medical Center, Cincinnati
Updated on 19 February 2024
covid-19
SARS
acute respiratory syndrome (sars)

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.

Details
Condition Covid 19
Age 18years - 100years
Treatment SARS-CoV-2
Clinical Study IdentifierNCT04472793
SponsorChildren's Hospital Medical Center, Cincinnati
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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