Characterizing the Immune Response and Neuronal Damage in COVID-19

NCT ID: NCT04510012

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-05

Study Completion Date

2021-01-30

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.

Conditions

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SARS-CoV Infection Covid-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mild COVID-19

SARS-Cov-2 infected individuals with mild symptoms (WHO Ordinal Scale for Clinical Improvement in COVID-19: scores 1-2)

Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.

Intervention Type 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)

Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.

Intervention Type 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)

Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.

Intervention Type OTHER

Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* PCR confirmed SARS-Cov-2 infection

Exclusion Criteria

* Refusal to participate
* Age \< 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bern

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cédric Hirzel, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Infectious Diseases, Bern University Hospital, Bern, Switzerland

Leib L Stephen, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Infectious Diseases; Bern University

Jörg C Schefold, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland

Locations

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Bern University Hospital

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 37939687 (View on PubMed)

Other Identifiers

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nCOV19

Identifier Type: -

Identifier Source: org_study_id

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