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

Hypohidrotic Ectodermal Dysplasia Clinical Trial

— PEDCOVID-19  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04741412
• Other study ID #: 212_20 B
• Status: Completed
• Start date: June 3, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: August 2021
• Source: University Hospital Erlangen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Ectodermal Dysplasia
• Hypohidrotic Ectodermal Dysplasia

Locations

Country	Name	City	State
Germany	University Hospital Erlangen	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Erlangen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	frequency of postviral fatigue	Patient-reported symptoms of fatigue are registered (questionnaire).	2-12 months from the onset of COVID-19 symptoms
Primary	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