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COVID-10 in the Pediatric Population: SARS-CoV-2 Seropositivity

NCT ID: NCT04690114

Last Updated: 2020-12-31

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

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-07-31

Brief Summary

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The purpose of this study was to conduct an epidemiological survey of the pediatric population via SARS CoV-2 IgG antibody testing in order to evaluate the incidence of asymptomatic infection and seropositivity among children and establish risk factors of infection and characterization of asymptomatic carriers. Additionally, among seropositive children, antibody titers will be explored in order to reach a better understanding of the relationship between immunity over time after different types of initial exposures.

Methods Study Design and Population A prospective epidemiological survey was conducted in the Pediatric Emergency Department (ED) of the Shaare Zedek Medical Center, a tertiary medical center in Jerusalem, Israel, between October 2020 and January 2021. All patients presenting to the pediatric ED during the study period and requiring blood tests or and IV insertion for any clinical reason were considered eligible to participate in the study. The parents and/or legal guardians of these patients gave oral consent for an additional 1-3 ml of blood to be sent for Sars-CoV-2 antibody testing. In addition, all consenting parent/guardians filled out a comprehensive questionnaire regarding demographic background, past medical history, and specific Covid-19 details such as exposures to carriers, past PCR testing, symptoms etc. All patients with positive serology results were contacted by phone and updated of the test results.

Laboratory testing All blood samples were collected in a clot-activator test tube. Initial testing was conducted using the Abbott SARS-CoV-2 IgG assay. A positive result was considered a value above 1.5 with 0.8 - 1.4 cosidered grayzone results. All positive and grayzone results were then retested in the DiaSoren LIAISON® SARS-CoV-2 S1/S2 IgG assay.

Statistical Analysis Statistical analysis was conducted using SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp. Clinical variables were analyzed using the Chi-squared test for categorical variables and the t-test for continuous variables. All statistical tests were two-way tests and P value of 5% or less was considered statistically significant.

Detailed Description

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Conditions

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SARS-CoV-2 Infection

Keywords

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Serology SARS-CoV-2 antibodies

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* All patients presenting to the Pediatric Emergency Department for any reason

Exclusion Criteria

* None
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Israel

OTHER_GOV

Sponsor Role collaborator

Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Adin Breuer

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eyal Heiman, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center

Locations

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Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Adin A Breuer, MD

Role: CONTACT

Phone: +972508464760

Email: [email protected]

Yuval Barrack-Korren, MD

Role: CONTACT

Phone: +972545873433

Email: [email protected]

Facility Contacts

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Adin A Breuer, MD

Role: primary

Other Identifiers

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0387-20-SZMC

Identifier Type: -

Identifier Source: org_study_id