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

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ClinicalTrials.gov Identifier: NCT04690114
Recruitment Status : Recruiting
First Posted : December 30, 2020
Last Update Posted : December 31, 2020
Sponsor:
Collaborator:
Ministry of Health, Israel
Information provided by (Responsible Party):
Adin Breuer, Shaare Zedek Medical Center

Tracking Information
First Submitted Date December 28, 2020
First Posted Date December 30, 2020
Last Update Posted Date December 31, 2020
Actual Study Start Date October 1, 2020
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 28, 2020)
Sars-CoV-2 Seropositivity [ Time Frame: Six months ]
Antibody titers of Sars-CoV-2 antibodies
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title COVID-10 in the Pediatric Population: SARS-CoV-2 Seropositivity
Official Title Incidence, Prevalence. Risk Factors and Epidemiology of SARS-CoV-2 Seropositivity in the Pediatric Population
Brief Summary

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 Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition SARS-CoV-2 Infection
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 28, 2020)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Adin A Breuer, MD +972508464760 adinbreuer@gmail.com
Contact: Yuval Barrack-Korren, MD +972545873433 yuvits@gmail.com
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT04690114
Other Study ID Numbers 0387-20-SZMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Adin Breuer, Shaare Zedek Medical Center
Study Sponsor Shaare Zedek Medical Center
Collaborators Ministry of Health, Israel
Investigators
Principal Investigator: Eyal Heiman, MD Shaare Zedek Medical Center
PRS Account Shaare Zedek Medical Center
Verification Date December 2020