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

August 13, 2021 updated by: Prof. Dr. Holm Schneider, University Hospital Erlangen

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

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

231

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany
        • University Hospital Erlangen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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 months from the point in time at which the first household member shows symptoms of COVID-19
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.
2 months from the onset of COVID-19 symptoms
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).
2-12 months from the onset of COVID-19 symptoms
frequency of postviral fatigue
Time Frame: 2-12 months from the onset of COVID-19 symptoms
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
Time Frame: 2-12 months from the onset of COVID-19 symptoms
Patient-reported extent of hair loss is registered (questionnaire).
2-12 months from the onset of COVID-19 symptoms

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Erlangen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2020

Primary Completion (Actual)

May 31, 2021

Study Completion (Actual)

May 31, 2021

Study Registration Dates

First Submitted

February 1, 2021

First Submitted That Met QC Criteria

February 4, 2021

First Posted (Actual)

February 5, 2021

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 13, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 212_20 B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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