Characterizing the Immune Response and Neuronal Damage in COVID-19

NCT04510012 | Completed

• 1 other identifier: nCOV19
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SARS-CoV Infection; Covid-19

Keywords

Innate immune response; Adaptive immune response; Inflammation; Neurological damage

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (2)

• Complement activation

  At enrollment

• Complement activation

  28 days (+/-7) after enrollment

Study Arms (3)

Mild COVID-19

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.

Moderate COVID-19

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.

Severe COVID-19

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.

Interventions

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.

Mild COVID-19; Moderate COVID-19; Severe COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult (≤ 18 years) patients with PCR confirmed SARS-Cov-2 infection

You may qualify if:

• PCR confirmed SARS-Cov-2 infection

You may not qualify if:

• Refusal to participate
• Age \< 18 years

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Study Sites (1)

Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 37939687 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, Plasma, Peripheral Blood Mononuclear Cells

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19; Inflammation; Trauma, Nervous System

Interventions

Adaptive Immunity; Complement Activation

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Immunity; Immune System Phenomena

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: March 5, 2020
• Primary Completion: December 18, 2020
• Study Completion: January 30, 2021
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)