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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04341168
• Other study ID #: KICC19
• Status: Not yet recruiting
• Start date: April 2020
• Est. completion date: October 2020

Study information

• Verified date: April 2020
• Source: University Hospital of Cologne
• Contact: Robert W Körner, Dr.
• Phone: +49 221 478
• Email: robert.koerner[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

Other:
• this study is non- interventional
this study is non- interventional

Locations

Country	Name	City	State
Germany	University Hospital Cologne	Cologne	NRW

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital of Cologne	Center for Molecular Medicine Cologne (CMMC) Cologne, Germany, Clinic for Internal Medicine I, University Hospital Cologne, Germany, Institute of Virology, University Hospital Cologne, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical course of COVID-19	Description of clinical course of COVID-19 in children, adolescents and adults	10/2020
Primary	Analysis of development of antibodies to SARS-CoV-2	Measurement of specific IgM- and IgG-antibody production	10/2020
Primary	Estimation of viral load	Estimation of viral load at initial presentation and after two weeks	10/2020
Primary	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
Primary	Measurement of cytokine and chemokine response	Determination of cytokine and chemokine concentrations in serum by ELISA.	12/2020
Primary	Characterisation of virus-host-interaction	Characterisation of virus-host-interaction by HLA-typing	12/2020
Primary	Identification of disease patterns in proteome	Identification of disease patterns in proteome by analysis of the proteome in serum and urine	12/2020
Primary	Analysis of change in lymphocyte subtypes	Detection of change in lymphocyte subtypes in blood and bronchoalveolar lavage	10/2020
Primary	Analysis of histological changes in severe lung disease	Analysis of histological changes in severe lung disease by lung biopsy	12/2020
Primary	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