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

Related Clinical Trial
Intraamniotic Administrations of ER004 in Male Subjects With X-linked Hypohidrotic Ectodermal Dysplasia Pediatric SARS-CoV-2 Infections: Course of COVID-19, Immune Responses, Complications and Long-term Consequences Male Subjects Affected By Hypohidrotic Ectodermal Dysplasia: Intrafamilial Variation Characterization of Sweat Gland Function in Patients With Recessively Inherited Hypohidrotic Ectodermal Dysplasia Sweat Duct Imaging in Mother/Newborn Dyads Natural History and Outcomes in X-Linked Hypohidrotic Ectodermal Dysplasia X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED) Carrier Outlook Toward Reproduction Survey Phenotypic Properties in Individuals Affected With XLHED Phase 2 Study to Evaluate Safety, Pharmacokinetics, Immunogenicity and Pharmacodynamics/Efficacy of EDI200 in Male Infants With X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED) Phenotypic and Genetic Properties in Males at Risk for X-linked Hypohidrotic Ectodermal Dysplasia: Evaluation of an Early Diagnosis Technology and Tests to Assess Nutritional Status A Cross-Sectional Natural History Study to Evaluate Sweat Volume and Other Phenotypic and Genetic Characteristics in Patients Affected by XLHED A Phase 1, Open-label, Multicenter, Safety and Pharmacokinetic Study of EDI200 Investigation of Chronic Inflammatory Processes in Male Individuals With Hypohidrotic Ectodermal Dysplasia Evaluation of Phenotypic and Genetic Properties in Male Subjects Affected By Hypohidrotic Ectodermal Dysplasia (ECP-012) Medical Record Review of Hypohidrotic Ectodermal Dysplasia Clinical Phenotype Extension Study of XLHED-Affected Male Subjects Treated With EDI200 in Protocol ECP-002 Short Term Effects and Risks of Physical Exercise in Subjects With Hypohidrotic Ectodermal Dysplasia Evaluation of Phenotypic and Genetic Properties in Male Subjects Affected by Hypohidrotic Ectodermal Dysplasia – A

Brief Title

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

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

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).
    



Study Type

Observational [Patient Registry]


Primary Outcome

age-dependence of SARS-CoV-2 infection


Condition

Hypohidrotic Ectodermal Dysplasia


Study Arms / Comparison Groups

 Hypohidrotic Ectodermal Dysplasia
Description:  all household members with hypohidrotic ectodermal dysplasia (HED), a rare hereditary developmental disorder

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

230

Start Date

June 3, 2020

Completion Date

May 31, 2021

Primary Completion Date

May 31, 2021

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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Holm Schneider, MD, +49 9131 85, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT04741412

Organization ID

212_20 B


Responsible Party

Principal Investigator

Study Sponsor

University Hospital Erlangen


Study Sponsor

Holm Schneider, MD, Principal Investigator, University Hospital Erlangen


Verification Date

April 2021