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| Name | Class |
|---|---|
| University of Bern | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild COVID-19 | SARS-Cov-2 infected individuals with mild symptoms (WHO Ordinal Scale for Clinical Improvement in COVID-19: scores 1-2) |
| |
| Moderate COVID-19 | SARS-Cov-2 infected individuals with moderate symptoms (WHO Ordinal Scale for Clinical Improvement in COVID-19: scores 3-4) |
| |
| Severe COVID-19 | SARS-Cov-2 infected individuals with severe symptoms (WHO Ordinal Scale for Clinical Improvement in COVID-19: scores 5-8) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cytokine response to SARS-Cov-2 | Measurement of cytokine concentration (pg/ml) in serum (IL-6, IL-8, IL-1b,TNF-alpha) | At enrollment |
| Cytokine response to SARS-Cov-2 | Measurement of cytokine concentration (pg/ml) in serum (IL-6, IL-8, IL-1b,TNF-alpha) | 28 days (+/-7) after enrollment |
| Innate immune response to SARS-Cov-2 | Measurement of HLA-DR expression on CD14+ cells (flowcytometry) | At enrollment |
| Innate immune response to SARS-Cov-2 | Measurement of HLA-DR expression on CD14+ cells (flowcytometry) | 3 days after enrollment |
| Innate immune response to SARS-Cov-2 | Measurement of HLA-DR expression on CD14+ cells (flowcytometry) | 5 days after enrollment |
| Humoral immune response | Measurement of neutralizing SARS-Cov-2 antibody concentrations (plaque reduction assay) | At enrollment |
| Cell mediated immune response | Measurement of frequencies of SARS-Cov-2 specific T-cells (ELISPOT assay) | At enrollment |
| Cell mediated immune response |
| Measure | Description | Time Frame |
|---|---|---|
| Complement activation | Measurement of factor B, factor H, factor I, C3a, C4a, C5a, SC5b9 | At enrollment |
| Complement activation | Measurement of factor B, factor H, factor I, C3a, C4a, C5a, SC5b9 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult (≤ 18 years) patients with PCR confirmed SARS-Cov-2 infection
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| Name | Affiliation | Role |
|---|---|---|
| Cédric Hirzel, MD | Department of Infectious Diseases, Bern University Hospital, Bern, Switzerland | Principal Investigator |
| Leib L Stephen, MD | Institute for Infectious Diseases; Bern University | Principal Investigator |
| Jörg C Schefold, MD | Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bern University Hospital | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37939687 | Derived | 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. |
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| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| D000086382 | COVID-19 |
| D007249 | Inflammation |
| D020196 | Trauma, Nervous System |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
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| ID | Term |
|---|---|
| D056704 | Adaptive Immunity |
| D003167 | Complement Activation |
| ID | Term |
|---|---|
| D007109 | Immunity |
| D055633 | Immune System Phenomena |
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Serum, Plasma, Peripheral Blood Mononuclear Cells
|
Measurement of frequencies of SARS-Cov-2 specific T-cells (ELISPOT assay)
| 28 days (+/-7) after enrollment |
| Neurological damage | Measurement of neurofilament light chains in serum (on ELLA platform; Protein Simple, Bio-techne) | At enrollment |
| Neurological damage | Measurement of neurofilament light chains in serum (on ELLA platform; Protein Simple, Bio-techne) | 28 days (+/-7) after enrollment |
| 28 days (+/-7) after enrollment |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |