Clinical and Immunological Characterisation of COVID-19 in Children, Adolescents and Adults

NCT04341168 | Unknown

• 1 other identifier: KICC19
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to characterise Coronavirus Disease 2019 (COVID-19) in every age group. On the one hand, emphasis is put on the initial presentation, clinical course, outcome and the therapy used. On the other hand further investigations regarding viral and bacterial coinfections, and response of the immune system will be conducted. This study should serve to improve the understanding of COVID-19, to identify risk factors for a severe clinical course and to obtain further insights into pathophysiology of this new infectious disease.

Conditions

COVID-19; SARS-CoV-2

Keywords

COVID-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (10)

• Clinical course of COVID-19

  Description of clinical course of COVID-19 in children, adolescents and adults

  10/2020

• Analysis of development of antibodies to SARS-CoV-2

  Measurement of specific IgM- and IgG-antibody production

  10/2020

• Estimation of viral load

  Estimation of viral load at initial presentation and after two weeks

  10/2020

• Detection of viral coinfections

  A Multiplex PCR will be conducted to test for the most common respiratroy viruses. A naso- and oropharyngeal swab will be used for this

  10/2020

• Measurement of cytokine and chemokine response

  Determination of cytokine and chemokine concentrations in serum by ELISA.

  12/2020

• Characterisation of virus-host-interaction

  Characterisation of virus-host-interaction by HLA-typing

  12/2020

• Identification of disease patterns in proteome

  Identification of disease patterns in proteome by analysis of the proteome in serum and urine

  12/2020

• Analysis of change in lymphocyte subtypes

  Detection of change in lymphocyte subtypes in blood and bronchoalveolar lavage

  10/2020

• Analysis of histological changes in severe lung disease

  Analysis of histological changes in severe lung disease by lung biopsy

  12/2020

• Detection of bacterial coinfections

  A pharyngeal swab will be cultured to check for bacteria residing in the upper airways. Additionally, a blood culture will serve to detect bacteremia

  10/2020

Study Arms (3)

Children and Adolescents with COVID-19

age range: newborn - 18 years old, subgroups will be established

Other: this study is non- interventional

Adults with COVID-19

age range: from 18 years old, subgroups will be established

Other: this study is non- interventional

Control group

all ages, any respiratory tract infection, subgroups will be established

Other: this study is non- interventional

Interventions

this study is non- interventional OTHER

this study is non- interventional

Adults with COVID-19; Children and Adolescents with COVID-19; Control group

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of all ages either with COVID-19 (symptomatic and asymptomatic) or a respiratory tract infection not caused by SARS-CoV-2

You may qualify if:

• patients with COVID-19: detection of SARS-CoV-2 by PCR in naso- or oropharyngeal swab or sputum, no age limit
• control group: any respiratory tract infection not caused by SARS-CoV-2, no age limit
• informed consent

You may not qualify if:

• no respiratory tract infection and no detection of SARS-CoV-2
• no informed consent

Sponsors & Collaborators

• University Hospital of Cologne: lead
• Clinic for Internal Medicine I, University Hospital Cologne, Germany: collaborator
• Institute of Virology, University Hospital Cologne, Germany: collaborator
• Center for Molecular Medicine Cologne (CMMC) Cologne, Germany: collaborator

Study Sites (1)

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

nasopharyngeal swab, oropharyngeal swab, sputum: obtain estimate for viral load of SARS-CoV-2, multiplex PCR for other respiratory viruses, bacterial culture blood: SARS-CoV-2-IgM and -IgG, routine lab values, blood - gas - analysis, blood culture, lymphocyte typing, cytokines, chemokines, HLA-typing, proteome urine: proteome bronchoalveolar lavage: obtain estimate for viral load of SARS-CoV-2, multiplex PCR for other respiratory viruses, bacterial culture, lymphocyte typing, cytokines, chemokines lung biopsy (optional): histology

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Robert W Körner, Dr.

  Children's University Hospital Cologne

  STUDY DIRECTOR

• Miguel A Alejandre Alcazar, Prof. Dr. Dr.

  Children's University Hospital Cologne

  STUDY DIRECTOR

Central Study Contacts

Robert W Körner, Dr.

CONTACT

+49 221 478; robert.koerner@uk-koeln.de

Jan Rybniker, PD Dr. Dr.

CONTACT

+49 221 478; jan.rybniker@uk-koeln.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 10, 2020
• Study Start: April 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)