Characterizing the Immune Response and Neuronal Damage in COVID-19

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Characterizing the Immune Response and Neuronal Damage in SARS-CoV-2 Infected Individuals

Conditions
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SARS-CoV Infection, Covid-19

Intervention / Treatment
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* Other: Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PCR confirmed SARS-Cov-2 infection Exclusion Criteria: Refusal to participate Age < 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mild COVID-19<br>SARS-Cov-2 infected individuals with mild symptoms (WHO Ordinal Scale for Clinical Improvement in COVID-19: scores 1-2) | Other: Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.<br>* Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.<br>|
| Moderate COVID-19<br>SARS-Cov-2 infected individuals with moderate symptoms (WHO Ordinal Scale for Clinical Improvement in COVID-19: scores 3-4) | Other: Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.<br>* Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.<br>|
| Severe COVID-19<br>SARS-Cov-2 infected individuals with severe symptoms (WHO Ordinal Scale for Clinical Improvement in COVID-19: scores 5-8) | Other: Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.<br>* Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 28 days (+/-7) after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Innate immune response, Adaptive immune response, Inflammation, Neurological damage