The purpose of this research study is 1) to conduct a prospective longitudinalsurveillance research trial, enrolling up to 200 CCHMC employees as they come back towork, 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. Theoverall goal is to investigate patterns of SARS-COV-2 infection, including immunologicalrecovery and genetic risk factors, among CCHMC employees to better understand how tosafely reintroduce the CCHMC work force back into their normal routines.
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.
Diagnostic Test: SARS-CoV-2
1. Testing weekly samples from nasal swabs to promptly diagnose acute COVID-19
infection.
2. Testing monthly serum samples to document post-viral infection.
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
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States