Characterizing the Immune Response and Neuronal Damage in COVID-19

Completed

• Conditions: Covid-19; SARS-CoV Infection
• Interventions: Other: Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.

• Registration Number: NCT04510012
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study Start: 2020-03-05
• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-11
• Study First Posted: 2020-08-12
• Primary Completion: 2020-12-18
• Study Completion: 2021-01-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• PCR confirmed SARS-Cov-2 infection

Exclusion Criteria

• Refusal to participate
• Age < 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe COVID-19	Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.	SARS-Cov-2 infected individuals with severe symptoms (WHO Ordinal Scale for Clinical Improvement in COVID-19: scores 5-8)
Mild COVID-19	Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.	SARS-Cov-2 infected individuals with mild symptoms (WHO Ordinal Scale for Clinical Improvement in COVID-19: scores 1-2)
Moderate COVID-19	Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.	SARS-Cov-2 infected individuals with moderate symptoms (WHO Ordinal Scale for Clinical Improvement in COVID-19: scores 3-4)

Primary Outcome Measures

Name	Time	Method
Cytokine response to SARS-Cov-2	28 days (+/-7) after enrollment	Measurement of cytokine concentration (pg/ml) in serum (IL-6, IL-8, IL-1b,TNF-alpha)
Humoral immune response	At enrollment	Measurement of neutralizing SARS-Cov-2 antibody concentrations (plaque reduction assay)
Innate immune response to SARS-Cov-2	5 days after enrollment	Measurement of HLA-DR expression on CD14+ cells (flowcytometry)
Cell mediated immune response	28 days (+/-7) after enrollment	Measurement of frequencies of SARS-Cov-2 specific T-cells (ELISPOT assay)
Neurological damage	28 days (+/-7) after enrollment	Measurement of neurofilament light chains in serum (on ELLA platform; Protein Simple, Bio-techne)

Secondary Outcome Measures

Name	Time	Method
Complement activation	28 days (+/-7) after enrollment	Measurement of factor B, factor H, factor I, C3a, C4a, C5a, SC5b9

Trial Locations

Locations (1)

Bern University Hospital; 🇨🇭 Bern, Switzerland