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 novelSARS-CoV2 virus. After the first case descriptions in Wuhan, there has been a rapidincrease 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 tractup to severe lung failure and death. Interestingly, up to now, children are usually lessseverely affected than adults. However, the actual infection rates are probably similarto those of adults, even if the actual prevalence in children is difficult to quantify sofar. The extent of the disease in children has also been less researched to date than inadults, and the same applies to pregnant women and their newborns. In addition, intensiveresearch 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 beable to understand the infection process and to protect the population with theirchildren, comprehensive testing is necessary. However, this poses great challenges forlocal health authorities. Scientific investigations are also costly, but are alreadybeing carried out by many institutes. So far, for example in the SeBlueCo study, a verylow prevalence of antibodies (1.3% of people) has been show. In children, however, boththe routes of infection and the way the immune system deals with the virus are probablydifferent than in adults. In this study the investigators now want to examine residualblood samples from pediatric patients of the pediatric and adolescent clinic in the timecourse after the beginning of the pandemic in order to better understand and monitor thedevelopment 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.

Unknown status
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