Serology to COVID-19 for Recording Exposures and Evaluating Needs

Study Overview
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Brief Summary
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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 had its first confirmed case of COVID-19 on March 14, 2020, and despite extensive shelter-in-place and social distancing efforts, community spread continues at over 150-200 new cases per week. As new residents and fellows arrive in July 2020 to Cincinnati Children's Hospital Medical Center (CCHMC), many of whom come from metropolitan areas across the country, it is imperative that investigators determine the current prevalence of infection, measure the cumulative incidence of infection over the next 12-24 months, investigate the normal antibody patterns after infection, and help elucidate what constitutes a protective immunological response. The investigators have a unique but time-limited opportunity to optimally track the epidemiology and natural history of SARS-CoV-2 infection among trainees at CCHMC, including risk factors for transmission and immunological recovery. SCREEN will investigate epidemiological and immunological features of SARS-CoV-2 virus infection within the cohort of CCHMC residents and fellows who have patient contact. 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), the investigators will determine the prevalence and cumulative incidence of infection by SARS-CoV-2; the investigators will also document the antibody responses over time and identify cases of apparent viral recrudescence or re-infection.

Official Title
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Serology to Covid for Recording Exposures and Evaluating Needs (SCREEN)

Conditions
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Covid19, Coronavirus, SARS-CoV Infection

Intervention / Treatment
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* Diagnostic Test: SARS-CoV-2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current full-time residents and fellows at CCHMC 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: Any condition or illness that makes study participation ill-advised

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Full-Time CCHMC Employees<br>All CCHMC full-time residents and fellows who have some direct contact with patients and their families as part of normal workplace duties. | Diagnostic Test: SARS-CoV-2<br>* Testing weekly samples from nasal swabs to promptly diagnose acute COVID-19 infection. Testing monthly serum samples to document post-viral infection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 12-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 12 months |