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Serology to COVID-19 for Recording Exposures and Evaluating Needs

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04566965
Acronym
SCREEN
Enrollment
232
Registered
2020-09-28
Start date
2020-08-18
Completion date
2021-06-30
Last updated
2021-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus, Covid19, SARS-CoV Infection

Brief summary

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.

Interventions

DIAGNOSTIC_TESTSARS-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.

Sponsors

Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
The 12-month cumulative incidence of acquired COVID infection in the study cohort.Weekly for 12 monthsAcquired 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026