COVID-19 Clinical Trial
Official title:
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.
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.
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