SARS-CoV2 Antibodies in Pediatric Patients (COVID-19) (SARS-CoV2_KIDS)

January 12, 2022 updated by: University of Erlangen-Nürnberg Medical School

Determination of SARS-CoV2 Antibody Prevalence in Pediatric Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Since the beginning of the year, the entire world has been concerned with a novel virus called SARS-CoV2. After the first case descriptions in Wuhan, there has been a rapid increase in the number of cases in Germany as well. In the case of a disease with the virus, the patients affected can suffer from a slight infection of the upper respiratory tract to severe lung failure and death. Since the beginning of the pandemic, an increasing number of complications such as thromboses, kidney failure and neurological damage have also been described. Interestingly, to date, children are usually less severely affected than adults, but the actual infection rates are probably similar to those of adults5 , although the actual prevalence in children is difficult to quantify and has so far been localized. The actual extent of the disease in children has also been little researched to date, and the same applies to pregnant women and their newborns.

In order to be able to understand the course of infection as well as possible and to protect the population, comprehensive testing is necessary. However, this poses great challenges for local health authorities. In addition, intensive research into possible therapy strategies and new vaccines is necessary. Here, however, the number of clinical trials in children is far behind. For adult patients, symptomatic therapies such as immunosuppressive drugs (dexamethasone) and controversially discussed antiviral drugs (e.g. ritonavir) are currently available. The medium-term goal, the establishment of a vaccine, seems to be within reach, but an exact date is not foreseeable.

In the future, in addition to the detection of the active virus by molecular diagnostic tests, the quantitative serological detection of antibodies will also be important in order to be able to make epidemiological statements about herd immunization or vaccination. An interim analysis of the SeBlueCo study showed a proportion of just 1.3% seropositive individuals among blood donors. Similar studies have already been registered and partially conducted throughout Germany. Some studies are also investigating pediatric patients, as both the routes of infection and the way the immune system deals with the virus are probably different from those in adults. Furthermore, the time course of antibody concentrations after infection with SARS-CoV2 and thus the duration of a safe immunity is much discussed. In this study, the investigators want to quantify the prevalence of SARS-Cov2 antibodies in children and adolescents during the pandemic, in order to describe the extent of antibody formation depending on various factors.

At the Children and Youth Clinic Erlangen, at least one blood sample will be taken from all inpatients and most of the patients treated as outpatients. At least one EDTA and one lithium heparin and often also one serum tube is taken. Due to the in-house laboratory, the analysis is designed for very small blood volumes. Therefore there is almost always some residual blood left in the blood tubes, which is then stored for about 7 days and only then discarded (reserve sample). For the study now planned, these residual blood samples from paediatric patients of the paediatric and adolescent clinic will serve as a basis for the analysis. The timing is such that 6, 12, 18 and 24 months after the outbreak of the pandemic in Germany, a SARS-Cov2 antibody prevalence of the local area will be determined. This will allow to investigate the local infection situation as well as the influence of a possibly available vaccination on the extent of immunization in the future.

Study Type

Observational

Enrollment (Anticipated)

7000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Antje Neubert, PhD
  • Phone Number: +91318533118

Study Locations

  • Germany
      • Erlangen, Germany, 91054
        • Recruiting
        • University Hospital Erlangen
        • Contact:
          • Antje Neubert, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • residual blood sample

Exclusion Criteria:

  • insufficient blood in the residual blood sample

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Residual blood of inpatients and outpatients will be analyzed anonymous with a quantitative test for the assessment of antibodies against SARS-CoV-2
Other Names:
  • Quantitative test for the assessment of 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
Residual blood of inpatients and outpatients will be analyzed anonymous with a quantitative test for the assessment of antibodies against SARS-CoV-2
Other Names:
  • Quantitative test for the assessment of 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
Residual blood of inpatients and outpatients will be analyzed anonymous with a quantitative test for the assessment of antibodies against SARS-CoV-2
Other Names:
  • Quantitative test for the assessment of 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
Residual blood of inpatients and outpatients will be analyzed anonymous with a quantitative test for the assessment of antibodies against SARS-CoV-2
Other Names:
  • Quantitative test for the assessment of 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
Residual blood of inpatients and outpatients will be analyzed anonymous with a quantitative test for the assessment of antibodies against SARS-CoV-2
Other Names:
  • Quantitative test for the assessment of 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
Residual blood of inpatients and outpatients will be analyzed anonymous with a quantitative test for the assessment of antibodies against SARS-CoV-2
Other Names:
  • Quantitative test for the assessment of 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
Residual blood of inpatients and outpatients will be analyzed anonymous with a quantitative test for the assessment of antibodies against SARS-CoV-2
Other Names:
  • Quantitative test for the assessment of 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
Residual blood of inpatients and outpatients will be analyzed anonymous with a quantitative test for the assessment of antibodies against SARS-CoV-2
Other Names:
  • Quantitative test for the assessment of 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
Residual blood of inpatients and outpatients will be analyzed anonymous with a quantitative test for the assessment of antibodies against SARS-CoV-2
Other Names:
  • Quantitative test for the assessment of 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
Residual blood of inpatients and outpatients will be analyzed anonymous with a quantitative test for the assessment of antibodies against SARS-CoV-2
Other Names:
  • Quantitative test for the assessment of antibodies against SARS-CoV-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of antibodies against SARS-CoV-2 at timepoint "M6, M12, M15, M19, M21, M22, M23, M24, M25 and M26"
Time Frame: Single assessment per patient in "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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative antibodies against SARS-CoV-2 at timepoint "M6, M12, M15, M19, M21, M22, M23, M24, M25 and M26"
Time Frame: Single assessment per patient in "M6, M12, M15, M19, M21, M22, M23, M24, M25 and M26"
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
Time Frame: 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"
Time Frame: 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"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Investigators

  • Principal Investigator: Antje Neubert, PhD, Department of Pediatric- and Adolescent Medicine, FAU Erlangen-Nürneberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2020

Primary Completion (ANTICIPATED)

June 30, 2022

Study Completion (ANTICIPATED)

June 30, 2022

Study Registration Dates

First Submitted

October 3, 2020

First Submitted That Met QC Criteria

October 6, 2020

First Posted (ACTUAL)

October 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2022

Last Update Submitted That Met QC Criteria

January 12, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 405_20 Bc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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