Clinical trial NCT04581148: SARS-CoV2 Antibodies in Pediatric Patients (COVID-19)
Official title: Determination of SARS-CoV2 Antibody Prevalence in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-Cov2
Keywords: SARS-Cov2
Pediatrics
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 7000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* residual blood sample

Exclusion Criteria:

* insufficient blood in the residual blood sample

Primary outcomes:
measure: Prevalence of antibodies against SARS-CoV-2 at timepoint "M6, M12, M15, M19, M21, M22, M23, M24, M25 and M26"
timeFrame: Single assessment per patient in "M6, M12, M15, M19, M21, M22, M23, M24, M25 and M26"
Secondary outcomes:
measure: Quantitative antibodies against SARS-CoV-2 at timepoint "M6, M12, M15, M19, M21, M22, M23, M24, M25 and M26"
timeFrame: Single assessment per patient in "M6, M12, M15, M19, M21, M22, M23, M24, M25 and M26"
measure: Rate of SARS-CoV-2 antibodies in comparison between month M6, M12, M15, M19, M21, M22, M23, M24, M25 and M26
timeFrame: Single assessment per patient in "M6, M12, M15, M19, M21, M22, M23, M24, M25 and M26"
measure: 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"
timeFrame: Single assessment per patient in "M6, M12, M15, M19, M21, M22, M23, M24, M25 and M26"
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital Erlangen
Study officials:
affiliation: Department of Pediatric- and Adolescent Medicine, FAU Erlangen-Nürneberg
name: Antje Neubert, PhD
role: PRINCIPAL_INVESTIGATOR
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