Serology to COVID-19 for Recording Exposures and Evaluating Needs

NCT04566965 | Terminated

• 1 other identifier: SCREEN
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Coronavirus; SARS-CoV Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

SARS-CoV-2 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.

Full-Time CCHMC Employees

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Any condition or illness that makes study participation ill-advised

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serial collections of weekly self-collected nasal swabs and monthly blood

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 28, 2020
• Study Start: August 18, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: December 22, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)