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

Sponsor
University of Erlangen-Nürnberg Medical School (Other)
Overall Status
Recruiting
CT.gov ID
NCT04581148
Collaborator
(none)
7,000
1
20.9
334.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Blood test antibodies against SARS-CoV-2

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 Design

Study Type:
Observational
Anticipated Enrollment :
7000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Determination of SARS-CoV2 Antibody Prevalence in Pediatric Patients
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. 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"]

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

    Secondary Outcome Measures

    1. 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"]

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

    2. 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"]

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

    3. 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"]

      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"

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Minute to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • residual blood sample
    Exclusion Criteria:
    • insufficient blood in the residual blood sample

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Erlangen Erlangen Germany 91054

    Sponsors and Collaborators

    • University of Erlangen-Nürnberg Medical School

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Erlangen-Nürnberg Medical School
    ClinicalTrials.gov Identifier:
    NCT04581148
    Other Study ID Numbers:
    • 405_20 Bc
    First Posted:
    Oct 9, 2020
    Last Update Posted:
    Jan 27, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Erlangen-Nürnberg Medical School
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 27, 2022