Serology to COVID-19 for Recording Exposures and Evaluating Needs (SCREEN)

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

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.

Study Overview

• Status: Terminated
• Conditions: Covid19; SARS-CoV Infection; Coronavirus
• Intervention / Treatment: Diagnostic test: SARS-CoV-2

• Study Type: Observational
• Enrollment (Actual): 232

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: SARS-CoV-2; Testing weekly samples from nasal swabs to promptly diagnose acute COVID-19 infection.; Testing monthly serum samples to document post-viral infection.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Russell Ware, MD, PhD, Children's Hospital Medical Center, Cincinnati; Principal Investigator: Mary Allen Staat, MD, MPH, Children's Hospital Medical Center, Cincinnati; Principal Investigator: Sue Poynter Wong, MD, MEd, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19
• Other Study ID Numbers: SCREEN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No