Official Title
Determination of SARS-CoV2 Antibody Prevalence in Pediatric Patients
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.

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.

Recruiting
SARS-COV2

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 Name: Quantitative test for the assessment of antibodies against SARS-CoV-2

Eligibility Criteria

Inclusion Criteria:

- residual blood sample

Exclusion Criteria:

- insufficient blood in the residual blood sample

Eligibility Gender
All
Eligibility Age
Minimum: 1 Minute ~ Maximum: 18 Years
Countries
Germany
Locations

University Hospital Erlangen
Erlangen, Germany

Investigator: Antje Neubert, PhD

Contacts

Adrian Regensburger, MD
+91318533118
adrian.regensburger@uk-erlangen.de

Antje Neubert, PhD
+91318533118

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

University of Erlangen-Nürnberg Medical School
NCT Number
Keywords
SARS-CoV2
Pediatrics
MeSH Terms
Antibodies
Immunoglobulins