COVID-19NCT04341168
Clinical and Immunological Characterisation of COVID-19 in Children, Adolescents and Adults
An observational study of COVID-19 and SARS-CoV-2, run by University Hospital of Cologne at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19, SARS-CoV-2
- What is being tested?
- this study is non- interventional
- How many people
- 160 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2020to Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients of all ages either with COVID-19 (symptomatic and asymptomatic) or a respiratory tract infection not caused by SARS-CoV-2
Who may be able to join
- 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
Who cannot join
- no respiratory tract infection and no detection of SARS-CoV-2
- no informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Cologne
Cologne, North Rhine-Westphalia, 50937
Robert W Koerner, Dr., +49221478 ext. 6083, robert.koerner@uk-koeln.de
Miguel A Alejandre Alcazar, Prof. Dr. Dr., +49221478 ext. 96887, miguel.alcazar@uk-koeln.de
About this study
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.
Read the 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.
- Conditions
- COVID-19, SARS-CoV-2
- Being tested
- this study is non- interventional
- Keywords
- COVID-19, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
this study is non- interventionalOther
this study is non- interventional
| Study group | Role | What they receive |
|---|---|---|
| Children and Adolescents with COVID-19 | age range: newborn - 18 years old, subgroups will be established Receives: Other: this study is non- interventional | |
| Adults with COVID-19 | age range: from 18 years old, subgroups will be established Receives: Other: this study is non- interventional | |
| Control group | all ages, any respiratory tract infection, subgroups will be established Receives: Other: this study is non- interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical course of COVID-19
Description of clinical course of COVID-19 in children, adolescents and adults
Measured: 10/2020
Analysis of development of antibodies to SARS-CoV-2
Measurement of specific IgM- and IgG-antibody production
Measured: 10/2020
Estimation of viral load
Estimation of viral load at initial presentation and after two weeks
Measured: 10/2020
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
Measured: 10/2020
Measurement of cytokine and chemokine response
Determination of cytokine and chemokine concentrations in serum by ELISA.
Measured: 12/2020
Characterisation of virus-host-interaction
Characterisation of virus-host-interaction by HLA-typing
Measured: 12/2020
Identification of disease patterns in proteome
Identification of disease patterns in proteome by analysis of the proteome in serum and urine
Measured: 12/2020
Analysis of change in lymphocyte subtypes
Detection of change in lymphocyte subtypes in blood and bronchoalveolar lavage
Measured: 10/2020
Analysis of histological changes in severe lung disease
Analysis of histological changes in severe lung disease by lung biopsy
Measured: 12/2020
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
Measured: 10/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study startApr 2020 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Molecular Medicine Cologne (CMMC) Cologne, Germany
- Responsible party
- Principal investigator, Dr. med. Robert W. Körner, University Hospital of Cologne
- Investigators
- Robert W Körner, Dr., Study director, Children's University Hospital CologneMiguel A Alejandre Alcazar, Prof. Dr. Dr., Study director, Children's University Hospital Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341168
- Sponsor's protocol ID
- KICC19
- Status last verified
- Apr 2020
- First submitted
- 3 Apr 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Immunological Characterisation of COVID-19 in Children, Adolescents and Adults
- ClinicalTrials.gov ID
- NCT04341168
- Acronym / sponsor ID
- KICC19
- Conditions
- COVID-19, SARS-CoV-2
- Keywords
- COVID-19, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Collaborators
- Center for Molecular Medicine Cologne (CMMC) Cologne, Germany
- Study start
- Apr 2020 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 10 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children and Adolescents with COVID-19 | – | Other: this study is non- interventionalage range: newborn - 18 years old, subgroups will be established |
| Adults with COVID-19 | – | Other: this study is non- interventionalage range: from 18 years old, subgroups will be established |
| Control group | – | Other: this study is non- interventionalall ages, any respiratory tract infection, subgroups will be established |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of all ages either with COVID-19 (symptomatic and asymptomatic) or a respiratory tract infection not caused by SARS-CoV-2
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- no respiratory tract infection and no detection of SARS-CoV-2
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| this study is non- interventionalthis study is non- interventional | Other | Adults with COVID-19, Children and Adolescents with COVID-19, Control group |
Primary outcome
Clinical course of COVID-19
Time frame: 10/2020
Description of clinical course of COVID-19 in children, adolescents and adults
Analysis of development of antibodies to SARS-CoV-2
Time frame: 10/2020
Measurement of specific IgM- and IgG-antibody production
Estimation of viral load
Time frame: 10/2020
Estimation of viral load at initial presentation and after two weeks
Detection of viral coinfections
Time frame: 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
Time frame: 12/2020
Determination of cytokine and chemokine concentrations in serum by ELISA.
Characterisation of virus-host-interaction
Time frame: 12/2020
Characterisation of virus-host-interaction by HLA-typing
Identification of disease patterns in proteome
Time frame: 12/2020
Identification of disease patterns in proteome by analysis of the proteome in serum and urine
Analysis of change in lymphocyte subtypes
Time frame: 10/2020
Detection of change in lymphocyte subtypes in blood and bronchoalveolar lavage
Analysis of histological changes in severe lung disease
Time frame: 12/2020
Analysis of histological changes in severe lung disease by lung biopsy
Detection of bacterial coinfections
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert W Körner, Dr. study director
Children's University Hospital Cologne
Miguel A Alejandre Alcazar, Prof. Dr. Dr. study director
Children's University Hospital Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SARS-CoV-2, run by University Hospital of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert W Körner, Dr. (+49 221 478 ext. 6083, robert.koerner@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical course of COVID-19 (time frame: 10/2020). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.