Pediatric SARS-CoV-2 Infections: Course of COVID-19, Immune Responses, Complications and Long-term Consequences

Study Overview
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Brief Summary
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Longitudinal study of 56 households with at least one member who had COVID-19 to compare the course of illness, immune responses, and long-term consequences of SARS-CoV-2 infection in HED patients with those of control subjects of the same age group. Complete households are investigated, including women who are pregnant when exposed to the virus and their newborn child(ren).

Official Title
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SARS-CoV-2 Infections in Children and Adolescents: Course of COVID-19, Immune Responses, Complications and Long-term Consequences in Entire Households With Members Younger Than 18 Years

Conditions
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Hypohidrotic Ectodermal Dysplasia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: household with one or more members registered as patient(s) in the University Hospital Erlangen at least one person <18 years of age at least one household member who has or had a SARS-CoV-2 infection confirmed by a positive PCR test, detection of specific antibodies against this virus, or by development of COVID-19 symptoms after being in close contact with a person known to be infected with SARS-CoV-2 informed consent Exclusion Criteria: missing informed consent of one or more household members language barriers to communication that would prevent informed consent
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypohidrotic Ectodermal Dysplasia<br>all household members with hypohidrotic ectodermal dysplasia (HED), a rare hereditary developmental disorder | |
| Control<br>individuals of the same age group, but without HED, including pregnant women | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| age-dependence of SARS-CoV-2 infection | registry of household members with and without symptoms of COVID-19 (entire households) | 3 months from the point in time at which the first household member shows symptoms of COVID-19 | 
| percentage of household members infected by SARS-CoV-2 | The infection rate is determined on the basis of specific PCR tests and detectibility of antibodies against SARS-CoV-2. | 3 months from the point in time at which the first household member shows symptoms of COVID-19 | 
| duration of primary COVID-19 symptoms | The possible association between the length of time with symptoms of COVID-19 and specific immune responses, in particular the development of virus-neutralizing antibodies, is studied. | 2 months from the onset of COVID-19 symptoms | 
| frequency of late-onset cardiovascular complications | Patient-reported known and yet unknown long-term consequences of COVID-19 are registered and investigated further (questionnaire, specific data confirmed by clinical examination). | 2-12 months from the onset of COVID-19 symptoms | 
| frequency of postviral fatigue | Patient-reported symptoms of fatigue are registered (questionnaire). | 2-12 months from the onset of COVID-19 symptoms | 
| frequency of noticeable temporary hair loss after COVID-19 | Patient-reported extent of hair loss is registered (questionnaire). | 2-12 months from the onset of COVID-19 symptoms |