Clinical trial NCT04341168: Clinical and Immunological Characterisation of COVID-19 in Children, Adolescents and Adults
Official title: Clinical and Immunological Characterisation of COVID-19 in Children, Adolescents and Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
SARS-CoV-2
Keywords: COVID-19
SARS-CoV-2
Lead sponsor: University Hospital of Cologne
Sponsor class: OTHER
Collaborators: name: Clinic for Internal Medicine I, University Hospital Cologne, Germany
name: Institute of Virology, University Hospital Cologne, Germany
name: Center for Molecular Medicine Cologne (CMMC) Cologne, Germany
First posted: 2020-04-10
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Clinical course of COVID-19
timeFrame: 10/2020
measure: Analysis of development of antibodies to SARS-CoV-2
timeFrame: 10/2020
measure: Estimation of viral load
timeFrame: 10/2020
measure: Detection of viral coinfections
timeFrame: 10/2020
measure: Measurement of cytokine and chemokine response
timeFrame: 12/2020
measure: Characterisation of virus-host-interaction
timeFrame: 12/2020
measure: Identification of disease patterns in proteome
timeFrame: 12/2020
measure: Analysis of change in lymphocyte subtypes
timeFrame: 10/2020
measure: Analysis of histological changes in severe lung disease
timeFrame: 12/2020
measure: Detection of bacterial coinfections
timeFrame: 10/2020
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital Cologne
state: NRW
Study officials:
affiliation: Children's University Hospital Cologne
name: Robert W Körner, Dr.
role: STUDY_DIRECTOR
affiliation: Children's University Hospital Cologne
name: Miguel A Alejandre Alcazar, Prof. Dr. Dr.
role: STUDY_DIRECTOR
References: