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

Sponsor
Children's Hospital Medical Center, Cincinnati (Other)
Overall Status
Terminated
CT.gov ID
NCT04566965
Collaborator
(none)
232
Enrollment
1
Location
10.4
Actual Duration (Months)
22.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: SARS-CoV-2

Study Design

Study Type:
Observational
Actual Enrollment :
232 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Serology to Covid for Recording Exposures and Evaluating Needs (SCREEN)
Actual Study Start Date :
Aug 18, 2020
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Cincinnati Children's Hospital Medical CenterCincinnatiOhioUnited States45229

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT04566965
Other Study ID Numbers:
  • SCREEN
First Posted:
Sep 28, 2020
Last Update Posted:
Dec 22, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 22, 2021