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Serology to COVID-19 for Recording Exposures and Evaluating Needs

NCT04566965 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 232

Last updated 2021-12-22

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Russell Ware, MD, PhD · Children's Hospital Medical Center, Cincinnati

  • Mary Allen Staat, MD, MPH · Children's Hospital Medical Center, Cincinnati

  • Sue Poynter Wong, MD, MEd · Children's Hospital Medical Center, Cincinnati

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-18
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04566965 on ClinicalTrials.gov