Serology to COVID-19 for Recording Exposures and Evaluating Needs

Terminated

• Conditions: Coronavirus; SARS-CoV Infection; Covid19
• Interventions: Diagnostic Test: SARS-CoV-2

• Registration Number: NCT04566965
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-18
• Study First Submitted: 2020-09-24
• Study First Submitted QC: 2020-09-25
• Study First Posted: 2020-09-28
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 232

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Full-Time CCHMC Employees	SARS-CoV-2	All CCHMC full-time residents and fellows who have some direct contact with patients and their families as part of normal workplace duties.

Primary Outcome Measures

Name	Time	Method
The 12-month cumulative incidence of acquired COVID infection in the study cohort.	Weekly for 12 months	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.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States