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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04341168
Recruitment Status : Unknown
Verified April 2020 by Dr. med. Robert W. Körner, University Hospital of Cologne.
Recruitment status was:  Not yet recruiting
First Posted : April 10, 2020
Last Update Posted : April 14, 2020
Sponsor:
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
Information provided by (Responsible Party):
Dr. med. Robert W. Körner, University Hospital of Cologne

Study Description
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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.

Condition or disease Intervention/treatment
COVID-19 SARS-CoV-2 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 Design
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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical and Immunological Characterisation of COVID-19 in Children, Adolescents and Adults
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Clinical course of COVID-19 [ Time Frame: 10/2020 ]
    Description of clinical course of COVID-19 in children, adolescents and adults

  2. Analysis of development of antibodies to SARS-CoV-2 [ Time Frame: 10/2020 ]
    Measurement of specific IgM- and IgG-antibody production

  3. Estimation of viral load [ Time Frame: 10/2020 ]
    Estimation of viral load at initial presentation and after two weeks

  4. Detection of viral coinfections [ Time Frame: 10/2020 ]
    A Multiplex PCR will be conducted to test for the most common respiratroy viruses. A naso- and oropharyngeal swab will be used for this

  5. Measurement of cytokine and chemokine response [ Time Frame: 12/2020 ]
    Determination of cytokine and chemokine concentrations in serum by ELISA.

  6. Characterisation of virus-host-interaction [ Time Frame: 12/2020 ]
    Characterisation of virus-host-interaction by HLA-typing

  7. Identification of disease patterns in proteome [ Time Frame: 12/2020 ]
    Identification of disease patterns in proteome by analysis of the proteome in serum and urine

  8. Analysis of change in lymphocyte subtypes [ Time Frame: 10/2020 ]
    Detection of change in lymphocyte subtypes in blood and bronchoalveolar lavage

  9. Analysis of histological changes in severe lung disease [ Time Frame: 12/2020 ]
    Analysis of histological changes in severe lung disease by lung biopsy

  10. Detection of bacterial coinfections [ Time Frame: 10/2020 ]
    A pharyngeal swab will be cultured to check for bacteria residing in the upper airways. Additionally, a blood culture will serve to detect bacteremia


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

Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04341168


Contacts
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Contact: Robert W Körner, Dr. +49 221 478 ext 6083 robert.koerner@uk-koeln.de
Contact: Jan Rybniker, PD Dr. Dr. +49 221 478 ext 89611 jan.rybniker@uk-koeln.de

Locations
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Germany
University Hospital Cologne
Cologne, NRW, Germany, 50937
Contact: Robert W Koerner, Dr.    +49221478 ext 6083    robert.koerner@uk-koeln.de   
Contact: Miguel A Alejandre Alcazar, Prof. Dr. Dr.    +49221478 ext 96887    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.         
Sponsors and Collaborators
University Hospital of Cologne
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
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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
More Information
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Responsible Party: Dr. med. Robert W. Körner, Study Director, University Hospital of Cologne
ClinicalTrials.gov Identifier: NCT04341168    
Other Study ID Numbers: KICC19
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. med. Robert W. Körner, University Hospital of Cologne:
COVID-19
SARS-CoV-2
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases