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Clinical Trials/NCT04510012
NCT04510012
Completed
Not Applicable

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

Insel Gruppe AG, University Hospital Bern1 site in 1 country88 target enrollmentMarch 5, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
SARS-CoV Infection
Sponsor
Insel Gruppe AG, University Hospital Bern
Enrollment
88
Locations
1
Primary Endpoint
Innate immune response to SARS-Cov-2
Status
Completed
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 5, 2020
End Date
January 30, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • PCR confirmed SARS-Cov-2 infection

Exclusion Criteria

  • Refusal to participate
  • Age \< 18 years

Outcomes

Primary Outcomes

Innate immune response to SARS-Cov-2

Time Frame: 5 days after enrollment

Measurement of HLA-DR expression on CD14+ cells (flowcytometry)

Cell mediated immune response

Time Frame: 28 days (+/-7) after enrollment

Measurement of frequencies of SARS-Cov-2 specific T-cells (ELISPOT assay)

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)

Humoral immune response

Time Frame: At enrollment

Measurement of neutralizing SARS-Cov-2 antibody concentrations (plaque reduction assay)

Neurological damage

Time Frame: 28 days (+/-7) after enrollment

Measurement of neurofilament light chains in serum (on ELLA platform; Protein Simple, Bio-techne)

Secondary Outcomes

  • Complement activation(28 days (+/-7) after enrollment)

Study Sites (1)

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