SARS-CoV InfectionNCT04510012
Characterizing the Immune Response and Neuronal Damage in COVID-19
An observational study of SARS-CoV Infection and Covid-19, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The Investigators plan to study the innate and adaptive immune response, the inflammatory response, and associated complications such as complement activation and neurological damage in SARS-Cov-2 infected individuals. Patients with mild, moderate and severe COVID-19 disease will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV Infection, Covid-19
- What is being tested?
- Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.
- How many people
- 88 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Mar 2020to 30 Jan 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (≤ 18 years) patients with PCR confirmed SARS-Cov-2 infection
Who may be able to join
- PCR confirmed SARS-Cov-2 infection
Who cannot join
- Refusal to participate
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterizing the Immune Response and Neuronal Damage in SARS-CoV-2 Infected Individuals
The Investigators plan to study the innate and adaptive immune response, the inflammatory response, and associated complications such as complement activation and neurological damage in SARS-Cov-2 infected individuals. Patients with mild, moderate and severe COVID-19 disease will be enrolled.
Read the detailed description
The severity of coronavirus disease 2019 (COVID-19) ranges from asymptomatic infection to severe illness requiring mechanical ventilation. Immunological factors which lead to severe disease in certain COVID-19 patients remain incompletely understood. Neurological damage and complement activation may be a consequence of excess inflammation in severe COVID-19. The investigators plan to study the innate and adaptive immune response and potentially associated complications such as neurological damage and complement activation in mild, moderate and severe COVID-19 courses.
- Conditions
- SARS-CoV Infection, Covid-19
- Being tested
- Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.
- Keywords
- Innate immune response, Adaptive immune response, Inflammation, Neurological damage
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19, Inflammation, Trauma, Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.Other
Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.
| Study group | Role | What they receive |
|---|---|---|
| Mild COVID-19 | SARS-Cov-2 infected individuals with mild symptoms (WHO Ordinal Scale for Clinical Improvement in COVID-19: scores 1-2) Receives: Other: Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage. | |
| Moderate COVID-19 | SARS-Cov-2 infected individuals with moderate symptoms (WHO Ordinal Scale for Clinical Improvement in COVID-19: scores 3-4) Receives: Other: Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage. | |
| Severe COVID-19 | SARS-Cov-2 infected individuals with severe symptoms (WHO Ordinal Scale for Clinical Improvement in COVID-19: scores 5-8) Receives: Other: Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine response to SARS-Cov-2
Measurement of cytokine concentration (pg/ml) in serum (IL-6, IL-8, IL-1b,TNF-alpha)
Measured: At enrollment
Cytokine response to SARS-Cov-2
Measurement of cytokine concentration (pg/ml) in serum (IL-6, IL-8, IL-1b,TNF-alpha)
Measured: 28 days (+/-7) after enrollment
Innate immune response to SARS-Cov-2
Measurement of HLA-DR expression on CD14+ cells (flowcytometry)
Measured: At enrollment
Innate immune response to SARS-Cov-2
Measurement of HLA-DR expression on CD14+ cells (flowcytometry)
Measured: 3 days after enrollment
Innate immune response to SARS-Cov-2
Measurement of HLA-DR expression on CD14+ cells (flowcytometry)
Measured: 5 days after enrollment
Humoral immune response
Measurement of neutralizing SARS-Cov-2 antibody concentrations (plaque reduction assay)
Measured: At enrollment
Cell mediated immune response
Measurement of frequencies of SARS-Cov-2 specific T-cells (ELISPOT assay)
Measured: At enrollment
Cell mediated immune response
Measurement of frequencies of SARS-Cov-2 specific T-cells (ELISPOT assay)
Measured: 28 days (+/-7) after enrollment
Neurological damage
Measurement of neurofilament light chains in serum (on ELLA platform; Protein Simple, Bio-techne)
Measured: At enrollment
Neurological damage
Measurement of neurofilament light chains in serum (on ELLA platform; Protein Simple, Bio-techne)
Measured: 28 days (+/-7) after enrollment
Secondary outcomes (2)
Complement activation
Measurement of factor B, factor H, factor I, C3a, C4a, C5a, SC5b9
Measured: At enrollment
Complement activation
Measurement of factor B, factor H, factor I, C3a, C4a, C5a, SC5b9
Measured: 28 days (+/-7) after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start5 Mar 2020
- Primary completion18 Dec 2020
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- Cédric Hirzel, MD, Principal investigator, Department of Infectious Diseases, Bern University Hospital, Bern, SwitzerlandLeib L Stephen, MD, Principal investigator, Institute for Infectious Diseases; Bern UniversityJörg C Schefold, MD, Principal investigator, Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510012
- Sponsor's protocol ID
- nCOV19
- Status last verified
- Jan 2023
- First submitted
- 10 Aug 2020
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruggeri T, De Wit Y, Scharz N, van Mierlo G, Angelillo-Scherrer A, Brodard J, Schefold JC, Hirzel C, Jongerius I, Zeerleder S. Immunothrombosis and Complement Activation Contribute to Disease Severity and Adverse Outcome in COVID-19. J Innate Immun. 2023;15(1):850-864. doi: 10.1159/000533339. Epub 2023 Nov 8.
PubMed 37939687
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Immune Response and Neuronal Damage in SARS-CoV-2 Infected Individuals
- ClinicalTrials.gov ID
- NCT04510012
- Acronym / sponsor ID
- nCOV19
- Conditions
- SARS-CoV Infection, Covid-19
- Keywords
- Innate immune response, Adaptive immune response, Inflammation, Neurological damage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 12 Aug 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 plan to study the innate and adaptive immune response, the inflammatory response, and associated complications such as complement activation and neurological damage in SARS-Cov-2 infected individuals. Patients with mild, moderate and severe COVID-19 disease will be enrolled.
Detailed description
The severity of coronavirus disease 2019 (COVID-19) ranges from asymptomatic infection to severe illness requiring mechanical ventilation. Immunological factors which lead to severe disease in certain COVID-19 patients remain incompletely understood. Neurological damage and complement activation may be a consequence of excess inflammation in severe COVID-19. The investigators plan to study the innate and adaptive immune response and potentially associated complications such as neurological damage and complement activation in mild, moderate and severe COVID-19 courses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild COVID-19 | – | Other: Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.SARS-Cov-2 infected individuals with mild symptoms (WHO Ordinal Scale for Clinical Improvement in COVID-19: scores 1-2) |
| Moderate COVID-19 | – | Other: Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.SARS-Cov-2 infected individuals with moderate symptoms (WHO Ordinal Scale for Clinical Improvement in COVID-19: scores 3-4) |
| Severe COVID-19 | – | Other: Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.SARS-Cov-2 infected individuals with severe symptoms (WHO Ordinal Scale for Clinical Improvement in COVID-19: scores 5-8) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (≤ 18 years) patients with PCR confirmed SARS-Cov-2 infection
Key inclusion criteria (1 listed)
- PCR confirmed SARS-Cov-2 infection
Key exclusion criteria (2 listed)
- Refusal to participate
- Age < 18 years
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 |
|---|---|---|
| Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage. | Other | Mild COVID-19, Moderate COVID-19, Severe COVID-19 |
Primary outcome
Cytokine response to SARS-Cov-2
Time frame: At enrollment
Measurement of cytokine concentration (pg/ml) in serum (IL-6, IL-8, IL-1b,TNF-alpha)
Cytokine response to SARS-Cov-2
Time frame: 28 days (+/-7) after enrollment
Measurement of cytokine concentration (pg/ml) in serum (IL-6, IL-8, IL-1b,TNF-alpha)
Innate immune response to SARS-Cov-2
Time frame: At enrollment
Measurement of HLA-DR expression on CD14+ cells (flowcytometry)
Innate immune response to SARS-Cov-2
Time frame: 3 days after enrollment
Measurement of HLA-DR expression on CD14+ cells (flowcytometry)
Innate immune response to SARS-Cov-2
Time frame: 5 days after enrollment
Measurement of HLA-DR expression on CD14+ cells (flowcytometry)
Humoral immune response
Time frame: At enrollment
Measurement of neutralizing SARS-Cov-2 antibody concentrations (plaque reduction assay)
Cell mediated immune response
Time frame: At enrollment
Measurement of frequencies of SARS-Cov-2 specific T-cells (ELISPOT assay)
Cell mediated immune response
Time frame: 28 days (+/-7) after enrollment
Measurement of frequencies of SARS-Cov-2 specific T-cells (ELISPOT assay)
Neurological damage
Time frame: At enrollment
Measurement of neurofilament light chains in serum (on ELLA platform; Protein Simple, Bio-techne)
Neurological damage
Time frame: 28 days (+/-7) after enrollment
Measurement of neurofilament light chains in serum (on ELLA platform; Protein Simple, Bio-techne)
2 secondary outcomes
Complement activation
Time frame: At enrollment
Complement activation
Time frame: 28 days (+/-7) after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Derived from this study: PubMed 37939687Ruggeri T, De Wit Y, Scharz N, van Mierlo G, Angelillo-Scherrer A, Brodard J, Schefold JC, Hirzel C, Jongerius I, Zeerleder S. Immunothrombosis and Complement Activation Contribute to Disease Severity and Adverse Outcome in COVID-19. J Innate Immun. 2023;15(1):850-864. doi: 10.1159/000533339. Epub 2023 Nov 8.
- 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.
Cédric Hirzel, MD principal investigator
Department of Infectious Diseases, Bern University Hospital, Bern, Switzerland
Leib L Stephen, MD principal investigator
Institute for Infectious Diseases; Bern University
Jörg C Schefold, MD principal investigator
Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland
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 SARS-CoV Infection and Covid-19, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 1 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: finished, as of the sponsor's last update on 26 Jan 2023. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokine response to SARS-Cov-2 (time frame: At enrollment). 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?
On the ClinicalTrials.gov record for NCT04510012, which also lists 1 linked publication.
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 26 Jan 2023.