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

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.

Study Overview

• Status: Unknown
• Conditions: COVID-19; SARS-CoV-2
• Intervention / Treatment: Other: this study is non- interventional

Detailed Description

In 2019 the novel coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified as the pathogen causing the Coronavirus Disease 2019 (COVID-19) pandemic. Many retrospective studies have been conducted regarding clinical signs and symptoms and clinical course of the disease. In most cases the infection causes only light symptoms of the upper respiratory tract. The infection can also be asymptomatic. However, in some the disease can cause a severe infection of the lower respiratory tract leading to acute respiratory syndrome (ARDS) which can be fatal. Especially elderly people suffer from severe disease whereas children are less compromised.

In this prospective, monocentric study the investigators include patients of all ages with COVID-19 and also a control group of all ages with respiratory tract infections other than COVID-19. Initial presentation, clinical course, outcome and the therapy used will be recorded. Standard diagnostic procedures (vital signs, results of blood samples, blood gas analysis, x ray, ct scan) will also be recorded. To further characterise the study population naso- and oropharyngeal swabs will be checked for viral and bacterial coinfections. The SARS-CoV-2 viral load will be estimated. To characterise the immunological response IgM- and IgG-antibodies for SARS-CoV-2 will be measured. Moreover lymphocyte typing, cytokine and chemokine analysis will be conducted. The investigators will also include an analysis of the proteome in serum and urine. To characterise the virus-host-interaction HLA analysis of the patients will be conducted. In the case of a medically indicated bronchoscopy bronchoalveolar lavage will be analysed in regards of viral load, coinfections, lymphocyte typing and cytokines / chemokines. In case of a medically indicated lung biopsy or in a post mortem lung biopsy a histological analysis will be made.

In general, samples will be analysed at the initial presentation and after two weeks. Further analysis will be conducted depending on special events like clinical deterioration. Long-term follow up will be ensured by telephone visits.

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

• Study Contact: Name: Robert W Körner, Dr.; Phone Number: 6083 +49 221 478; Email: robert.koerner@uk-koeln.de
• Study Contact Backup: Name: Jan Rybniker, PD Dr. Dr.; Phone Number: 89611 +49 221 478; Email: jan.rybniker@uk-koeln.de

Study Locations

• Germany
  • NRW
    • Cologne, NRW, Germany, 50937
      • University Hospital Cologne
      • Contact: Robert W Koerner, Dr.; Phone Number: 6083 +49221478; Email: robert.koerner@uk-koeln.de
      • Contact: Miguel A Alejandre Alcazar, Prof. Dr. Dr.; Phone Number: 96887 +49221478; Email: miguel.alcazar@uk-koeln.de
      • Principal Investigator: Jan Rybniker, PD Dr. Dr.
      • Principal Investigator: Saleta Sierra - Aragón, PD Dr.
      • Principal Investigator: Rolf Kaiser, Dr.
      • Principal Investigator: Florian Klein, PD Dr.
      • Principal Investigator: Julia Fischer, Dr.
      • Principal Investigator: Katja Höpker, PD Dr.
      • Principal Investigator: Tom Schildberg, Dr.
      • Principal Investigator: Centina Kuiper-Makris
      • Principal Investigator: Esther Mahabir-Brenner, Prof. Dr.
      • Principal Investigator: Christoph Hünseler, PD Dr.
      • Principal Investigator: Lutz Weber, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children and Adolescents with COVID-19; age range: newborn - 18 years old, subgroups will be established	Other: this study is non- interventional; 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; this study is non- interventional
Control group; all ages, any respiratory tract infection, subgroups will be established	Other: this study is non- interventional; this study is non- interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital of Cologne
• Collaborators: Clinic for Internal Medicine I, University Hospital Cologne, Germany; Institute of Virology, University Hospital Cologne, Germany; Center for Molecular Medicine Cologne (CMMC) Cologne, Germany
• Investigators: Study Director: Robert W Körner, Dr., Children's University Hospital Cologne; Study Director: Miguel A Alejandre Alcazar, Prof. Dr. Dr., Children's University Hospital Cologne

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: April 3, 2020
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Actual): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 11, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: KICC19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No