SARS-CoV2 Antibodies in Pediatric Patients (COVID-19)

NCT04581148 | Unknown

• 1 other identifier: 405_20 Bc
• Study Type: observational
• Target: 7,000
• Locations: 1 country
• Sites: 1

Brief Summary

Since the beginning of the year, the entire world has been concerned with the novel SARS-CoV2 virus. After the first case descriptions in Wuhan, there has been a rapid increase in the number of cases in Germany as well. In case of an illness with the virus, the affected patients can suffer from a slight infection of the upper respiratory tract up to severe lung failure and death. Interestingly, up to now, children are usually less severely affected than adults. However, the actual infection rates are probably similar to those of adults, even if the actual prevalence in children is difficult to quantify so far. The extent of the disease in children has also been less researched to date than in adults, and the same applies to pregnant women and their newborns. In addition, intensive research into possible therapeutic strategies and new vaccines is necessary. Here, however, the number of clinical studies in children is also far behind. In order to be able to understand the infection process and to protect the population with their children, comprehensive testing is necessary. However, this poses great challenges for local health authorities. Scientific investigations are also costly, but are already being carried out by many institutes. So far, for example in the SeBlueCo study, a very low prevalence of antibodies (1.3% of people) has been show. In children, however, both the routes of infection and the way the immune system deals with the virus are probably different than in adults. In this study the investigators now want to examine residual blood samples from pediatric patients of the pediatric and adolescent clinic in the time course after the beginning of the pandemic in order to better understand and monitor the development of antibody prevalence.

Conditions

SARS-Cov2

Keywords

SARS-Cov2; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Prevalence of antibodies against SARS-CoV-2 at timepoint "M6, M12, M15, M19, M21, M22, M23, M24, M25 and M26"

  Prevalence of antibodies against SARS-CoV-2 at timepoint "M6, M12, M15, M19, M21, M22, M23, M24, M25 and M26"

  Single assessment per patient in "M6, M12, M15, M19, M21, M22, M23, M24, M25 and M26"

Secondary Outcomes (3)

• Quantitative antibodies against SARS-CoV-2 at timepoint "M6, M12, M15, M19, M21, M22, M23, M24, M25 and M26"

  Single assessment per patient in "M6, M12, M15, M19, M21, M22, M23, M24, M25 and M26"

• Rate of SARS-CoV-2 antibodies in comparison between month M6, M12, M15, M19, M21, M22, M23, M24, M25 and M26

  Single assessment per patient in "M6, M12, M15, M19, M21, M22, M23, M24, M25 and M26"

• Stratification of the antibodies against SARS-Cov-2 with patient characteristics (age, gender, clinical history) at timepoint "M6, M12, M15, M19, M21, M22, M23, M24, M25 and M26"

  Single assessment per patient in "M6, M12, M15, M19, M21, M22, M23, M24, M25 and M26"

Study Arms (10)

M6

All inpatient and outpatient patients of the Department of Pediatric- and Adolescent medicine of the University Hospital Erlangen in 4 weeks (M6) with residual blood samples.

Diagnostic Test: Blood test antibodies against SARS-CoV-2

M12

All inpatient and outpatient patients of the Department of Pediatric- and Adolescent medicine of the University Hospital Erlangen in 4 weeks (M12) with residual blood samples.

Diagnostic Test: Blood test antibodies against SARS-CoV-2

M15

All inpatient and outpatient patients of the Department of Pediatric- and Adolescent medicine of the University Hospital Erlangen in 4 weeks (M15) with residual blood samples.

Diagnostic Test: Blood test antibodies against SARS-CoV-2

M19

All inpatient and outpatient patients of the Department of Pediatric- and Adolescent medicine of the University Hospital Erlangen in 4 weeks (M19) with residual blood samples.

Diagnostic Test: Blood test antibodies against SARS-CoV-2

M21

All inpatient and outpatient patients of the Department of Pediatric- and Adolescent medicine of the University Hospital Erlangen in 4 weeks (M21) with residual blood samples.

Diagnostic Test: Blood test antibodies against SARS-CoV-2

M22

All inpatient and outpatient patients of the Department of Pediatric- and Adolescent medicine of the University Hospital Erlangen in 4 weeks (M22) with residual blood samples.

Diagnostic Test: Blood test antibodies against SARS-CoV-2

M23

All inpatient and outpatient patients of the Department of Pediatric- and Adolescent medicine of the University Hospital Erlangen in 4 weeks (M23) with residual blood samples.

Diagnostic Test: Blood test antibodies against SARS-CoV-2

M24

All inpatient and outpatient patients of the Department of Pediatric- and Adolescent medicine of the University Hospital Erlangen in 4 weeks (M24) with residual blood samples.

Diagnostic Test: Blood test antibodies against SARS-CoV-2

M25

All inpatient and outpatient patients of the Department of Pediatric- and Adolescent medicine of the University Hospital Erlangen in 4 weeks (M25) with residual blood samples.

Diagnostic Test: Blood test antibodies against SARS-CoV-2

M26

All inpatient and outpatient patients of the Department of Pediatric- and Adolescent medicine of the University Hospital Erlangen in 4 weeks (M26) with residual blood samples.

Diagnostic Test: Blood test antibodies against SARS-CoV-2

Interventions

Blood test antibodies against SARS-CoV-2 DIAGNOSTIC_TEST

Residual blood of inpatients and outpatients will be analyzed anonymous with a quantitative test for the assessment of antibodies against SARS-CoV-2

Also known as: Quantitative test for the assessment of antibodies against SARS-CoV-2

M12; M15; M19; M21; M22; M23; M24; M25; M26; M6

Eligibility Criteria

• Age: 1 Minute - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All patients who were treated in the respective month (M6, M12, M15, M18, M24) in the Department of Children and Adolescent Medicine as outpatients, inpatients or semi-inpatients.

You may qualify if:

• residual blood sample

You may not qualify if:

• insufficient blood in the residual blood sample

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University Hospital Erlangen

Erlangen, 91054, Germany

RECRUITING

Related Publications (12)

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• Diriba K, Awulachew E, Getu E. The effect of coronavirus infection (SARS-CoV-2, MERS-CoV, and SARS-CoV) during pregnancy and the possibility of vertical maternal-fetal transmission: a systematic review and meta-analysis. Eur J Med Res. 2020 Sep 4;25(1):39. doi: 10.1186/s40001-020-00439-w.

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• Hwang TJ, Randolph AG, Bourgeois FT. Inclusion of Children in Clinical Trials of Treatments for Coronavirus Disease 2019 (COVID-19). JAMA Pediatr. 2020 Sep 1;174(9):825-826. doi: 10.1001/jamapediatrics.2020.1888. No abstract available.

  PMID: 32379296 BACKGROUND

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Study Officials

• Antje Neubert, PhD

  Department of Pediatric- and Adolescent Medicine, FAU Erlangen-Nürneberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrian Regensburger, MD

CONTACT

+91318533118; adrian.regensburger@uk-erlangen.de

Antje Neubert, PhD

CONTACT

+91318533118

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2020
• First Posted: October 9, 2020
• Study Start: October 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)