Characterizing the Immune Response and Neuronal Damage in COVID-19

January 25, 2023 updated by: University Hospital Inselspital, Berne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Bern University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • PCR confirmed SARS-Cov-2 infection

Exclusion Criteria:

  • Refusal to participate
  • Age < 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At enrollment
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)
28 days (+/-7) after enrollment
Innate immune response to SARS-Cov-2
Time Frame: At enrollment
Measurement of HLA-DR expression on CD14+ cells (flowcytometry)
At enrollment
Innate immune response to SARS-Cov-2
Time Frame: 3 days after enrollment
Measurement of HLA-DR expression on CD14+ cells (flowcytometry)
3 days after enrollment
Innate immune response to SARS-Cov-2
Time Frame: 5 days after enrollment
Measurement of HLA-DR expression on CD14+ cells (flowcytometry)
5 days after enrollment
Humoral immune response
Time Frame: At enrollment
Measurement of neutralizing SARS-Cov-2 antibody concentrations (plaque reduction assay)
At enrollment
Cell mediated immune response
Time Frame: At enrollment
Measurement of frequencies of SARS-Cov-2 specific T-cells (ELISPOT assay)
At enrollment
Cell mediated immune response
Time Frame: 28 days (+/-7) after enrollment
Measurement of frequencies of SARS-Cov-2 specific T-cells (ELISPOT assay)
28 days (+/-7) after enrollment
Neurological damage
Time Frame: At enrollment
Measurement of neurofilament light chains in serum (on ELLA platform; Protein Simple, Bio-techne)
At enrollment
Neurological damage
Time Frame: 28 days (+/-7) after enrollment
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
Time Frame: At enrollment
Measurement of factor B, factor H, factor I, C3a, C4a, C5a, SC5b9
At enrollment
Complement activation
Time Frame: 28 days (+/-7) after enrollment
Measurement of factor B, factor H, factor I, C3a, C4a, C5a, SC5b9
28 days (+/-7) after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

University of Bern

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2020

Primary Completion (Actual)

December 18, 2020

Study Completion (Actual)

January 30, 2021

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 11, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nCOV19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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