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

NCT ID: NCT04741412

Last Updated: 2021-08-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 231 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-03
• Study Completion Date: 2021-05-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Hypohidrotic Ectodermal Dysplasia

all household members with hypohidrotic ectodermal dysplasia (HED), a rare hereditary developmental disorder

No interventions assigned to this group

Control

individuals of the same age group, but without HED, including pregnant women

No interventions assigned to this group

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Erlangen

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Holm Schneider

Head, Center of Ectodermal Dysplasias

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Holm Schneider, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Erlangen

Locations

University Hospital Erlangen

Erlangen, , Germany

Countries

Germany

Other Identifiers

212_20 B

Identifier Type: -

Identifier Source: org_study_id