Serology to COVID-19 for Recording Exposures and Evaluating Needs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

232 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-18

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Collection of SARS CoV-2 (COVID-19) Virus Secretions and Serum for Countermeasure Development

NCT04956445

Covid19

RECRUITING

A Registry Study of COVID-19 Serologic and Virologic Testing to Accelerate Recovery and Transition

NCT04573634

Covid19 SARS-CoV Infection

WITHDRAWN

Factors Associated With a Positive SARS-CoV-2 Serology in Contact Subjects at High/Moderate Risk of Coronavirus SARS-CoV-2 Infection. COVID-19.

NCT04322279

Coronavirus

TERMINATED

Serology COVID-19 From the Cornwall Hospital Union

NCT04363593

Corona Virus Infection

COMPLETED NA

Description of Immunologic, Enzymatic and Metabolic Biomarkers Associated to the Severity of COVID-19 (SARS-CoV-2) and Its Resolution

NCT04664023

Covid19

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19 Coronavirus SARS-CoV Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

SARS-CoV-2

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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