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CompletedNCT04741412PEDCOVID-19Updated Aug 16, 2021

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

An observational study in Hypohidrotic Ectodermal Dysplasia, sponsored by University Hospital Erlangen. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2021-08-16.

Sponsored by University Hospital Erlangen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
231
Sex
All
01

Study summary

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).

02

Conditions studied

  • Hypohidrotic Ectodermal Dysplasia
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

households with children and/or adolescents and at least one member who has or had a SARS-CoV-2 infection

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

Exclusion Criteria:

  • missing informed consent of one or more household members
  • language barriers to communication that would prevent informed consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
231 participants (actual)
Target follow-up
6 Months
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Hypohidrotic Ectodermal Dysplasia

    all household members with hypohidrotic ectodermal dysplasia (HED), a rare hereditary developmental disorder

  • Control

    individuals of the same age group, but without HED, including pregnant women

05

What researchers measure

Primary outcomes

  1. age-dependence of SARS-CoV-2 infection

    registry of household members with and without symptoms of COVID-19 (entire households)

    Time frame: 3 months from the point in time at which the first household member shows symptoms of COVID-19

  2. 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.

    Time frame: 3 months from the point in time at which the first household member shows symptoms of COVID-19

  3. 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.

    Time frame: 2 months from the onset of COVID-19 symptoms

  4. 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).

    Time frame: 2-12 months from the onset of COVID-19 symptoms

  5. frequency of postviral fatigue

    Patient-reported symptoms of fatigue are registered (questionnaire).

    Time frame: 2-12 months from the onset of COVID-19 symptoms

  6. frequency of noticeable temporary hair loss after COVID-19

    Patient-reported extent of hair loss is registered (questionnaire).

    Time frame: 2-12 months from the onset of COVID-19 symptoms

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Study locations

1 site
  • University Hospital Erlangen
    Erlangen, Germany
07

Registry details

Key details

Study ID
NCT04741412
Lead sponsor
University Hospital Erlangen
Responsible party
Prof. Dr. Holm Schneider (Head, Center of Ectodermal Dysplasias, University Hospital Erlangen) — Principal investigator
First posted
Feb 5, 2021
Start date
Jun 3, 2020
Primary completion
May 31, 2021
Completion
May 31, 2021
Last update
Aug 16, 2021

Study contacts

Holm Schneider, MD
principal investigator · University Hospital Erlangen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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