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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Inselspital, Berne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Bern

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 18, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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