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

Completed

• Conditions: Hypohidrotic Ectodermal Dysplasia

• Registration Number: NCT04741412
• Lead Sponsor: University Hospital Erlangen

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-03
• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-05
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-13
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)
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.
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.
frequency of postviral fatigue	2-12 months from the onset of COVID-19 symptoms	Patient-reported symptoms of fatigue are registered (questionnaire).
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).
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).

Trial Locations

Locations (1)

University Hospital Erlangen; 🇩🇪 Erlangen, Germany