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Serology to COVID-19 for Recording Exposures and Evaluating Needs

NCT ID: NCT04566965

Last Updated: 2021-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

232 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-18

Study Completion Date

2021-06-30

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.

Detailed Description

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Conditions

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Covid19 Coronavirus SARS-CoV Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Full-Time CCHMC Employees

All CCHMC full-time residents and fellows who have some direct contact with patients and their families as part of normal workplace duties.

SARS-CoV-2

Intervention Type DIAGNOSTIC_TEST

1. Testing weekly samples from nasal swabs to promptly diagnose acute COVID-19 infection.
2. Testing monthly serum samples to document post-viral infection.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Russell Ware, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Mary Allen Staat, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Sue Poynter Wong, MD, MEd

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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SCREEN

Identifier Type: -

Identifier Source: org_study_id