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临床试验/NCT04341168
NCT04341168Unknown不适用

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

University Hospital of Cologne1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2020年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
160
试验地点
1
主要终点
Clinical course of COVID-19

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • no respiratory tract infection and no detection of SARS-CoV-2
  • no informed consent

结局指标

主要结局

Clinical course of COVID-19

时间窗: 10/2020

Description of clinical course of COVID-19 in children, adolescents and adults

Analysis of development of antibodies to SARS-CoV-2

时间窗: 10/2020

Measurement of specific IgM- and IgG-antibody production

Estimation of viral load

时间窗: 10/2020

Estimation of viral load at initial presentation and after two weeks

Detection of viral coinfections

时间窗: 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

时间窗: 12/2020

Determination of cytokine and chemokine concentrations in serum by ELISA.

Analysis of histological changes in severe lung disease

时间窗: 12/2020

Analysis of histological changes in severe lung disease by lung biopsy

Characterisation of virus-host-interaction

时间窗: 12/2020

Characterisation of virus-host-interaction by HLA-typing

Identification of disease patterns in proteome

时间窗: 12/2020

Identification of disease patterns in proteome by analysis of the proteome in serum and urine

Analysis of change in lymphocyte subtypes

时间窗: 10/2020

Detection of change in lymphocyte subtypes in blood and bronchoalveolar lavage

Detection of bacterial coinfections

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
University Hospital of Cologne
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. med. Robert W. Körner

Study Director

University Hospital of Cologne

研究点 (1)

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