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

Sponsor
University Hospital Erlangen (Other)
Overall Status
Completed
CT.gov ID
NCT04741412
Collaborator
(none)
231
Enrollment
1
Location
11.9
Actual Duration (Months)
19.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    231 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official 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
    Actual Study Start Date :
    Jun 3, 2020
    Actual Primary Completion Date :
    May 31, 2021
    Actual Study Completion Date :
    May 31, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. age-dependence of SARS-CoV-2 infection [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 [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 [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 [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 [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 [2-12 months from the onset of COVID-19 symptoms]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Erlangen Erlangen Germany

    Sponsors and Collaborators

    • University Hospital Erlangen

    Investigators

    • Principal Investigator: Holm Schneider, MD, University Hospital Erlangen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Dr. Holm Schneider, Head, Center of Ectodermal Dysplasias, University Hospital Erlangen
    ClinicalTrials.gov Identifier:
    NCT04741412
    Other Study ID Numbers:
    • 212_20 B
    First Posted:
    Feb 5, 2021
    Last Update Posted:
    Aug 16, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Ectodermal Dysplasia
    Ectodermal Dysplasia 1, Anhidrotic

    Study Results

    No Results Posted as of Aug 16, 2021