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

NCT04741412 | Completed

• 1 other identifier: 212_20 B
• Study Type: observational
• Target: 231
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypohidrotic Ectodermal Dysplasia

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Erlangen: lead

Study Sites (1)

University Hospital Erlangen

Erlangen, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, peripheral blood mononuclear cells

MeSH Terms

Conditions

Ectodermal Dysplasia 1, Anhidrotic

Condition Hierarchy (Ancestors)

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

Study Officials

• Holm Schneider, MD

  University Hospital Erlangen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Center of Ectodermal Dysplasias

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 5, 2021
• Study Start: June 3, 2020
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: August 16, 2021

Record last verified: 2021-08

Locations

DE (1)