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Completed

NCT Number: NCT04741412

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

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).

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Key information

Conditions

Hypohidrotic Ectodermal Dysplasia Abnormalities, Multiple Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ectodermal Dysplasia Ectodermal Dysplasia 1, Anhidrotic Genetic Diseases, Inborn Genetic Diseases, X-Linked Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Erlangen

Erlangen, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

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

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

  2. percentage of household members infected by SARS-CoV-2

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

    The infection rate is determined on the basis of specific PCR tests and detectibility of antibodies against SARS-CoV-2.

  3. duration of primary COVID-19 symptoms

    Time frame: 2 months from the onset of 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.

  4. frequency of late-onset cardiovascular complications

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

    Patient-reported known and yet unknown long-term consequences of COVID-19 are registered and investigated further (questionnaire, specific data confirmed by clinical examination).

  5. frequency of postviral fatigue

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

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

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

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

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

Sponsors and collaborators

Lead sponsor

University Hospital Erlangen

Other

Registry information

Official study title

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

Acronym: PEDCOVID-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2021
Registry last updated
Aug 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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