Clinical and Immunological Characterisation of COVID-19 in Children, Adolescents and Adults
- Conditions
- COVID-19SARS-CoV-2
- Interventions
- Other: this study is non- interventional
- Registration Number
- NCT04341168
- Lead Sponsor
- University Hospital of Cologne
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
- 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
- no respiratory tract infection and no detection of SARS-CoV-2
- no informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Children and Adolescents with COVID-19 this study is non- interventional age range: newborn - 18 years old, subgroups will be established Adults with COVID-19 this study is non- interventional age range: from 18 years old, subgroups will be established Control group this study is non- interventional all ages, any respiratory tract infection, subgroups will be established
- Primary Outcome Measures
Name Time Method Characterisation of virus-host-interaction 12/2020 Characterisation of virus-host-interaction by HLA-typing
Clinical course of COVID-19 10/2020 Description of clinical course of COVID-19 in children, adolescents and adults
Analysis of development of antibodies to SARS-CoV-2 10/2020 Measurement of specific IgM- and IgG-antibody production
Estimation of viral load 10/2020 Estimation of viral load at initial presentation and after two weeks
Detection of viral coinfections 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
Measurement of cytokine and chemokine response 12/2020 Determination of cytokine and chemokine concentrations in serum by ELISA.
Analysis of histological changes in severe lung disease 12/2020 Analysis of histological changes in severe lung disease by lung biopsy
Identification of disease patterns in proteome 12/2020 Identification of disease patterns in proteome by analysis of the proteome in serum and urine
Analysis of change in lymphocyte subtypes 10/2020 Detection of change in lymphocyte subtypes in blood and bronchoalveolar lavage
Detection of bacterial coinfections 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital Cologne
🇩🇪Cologne, NRW, Germany