Characterizing the Immune Response and Neuronal Damage in COVID-19

Covid-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04510012
• Other study ID #: nCOV19
• Status: Completed
• Start date: March 5, 2020
• Est. completion date: January 30, 2021

Study information

• Verified date: January 2023
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: January 30, 2021
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• PCR confirmed SARS-Cov-2 infection

Exclusion Criteria:

• Refusal to participate

• Age < 18 years

Related Conditions & MeSH terms

• Covid-19
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Bern University Hospital	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokine response to SARS-Cov-2	Measurement of cytokine concentration (pg/ml) in serum (IL-6, IL-8, IL-1b,TNF-alpha)	At enrollment
Primary	Cytokine response to SARS-Cov-2	Measurement of cytokine concentration (pg/ml) in serum (IL-6, IL-8, IL-1b,TNF-alpha)	28 days (+/-7) after enrollment
Primary	Innate immune response to SARS-Cov-2	Measurement of HLA-DR expression on CD14+ cells (flowcytometry)	At enrollment
Primary	Innate immune response to SARS-Cov-2	Measurement of HLA-DR expression on CD14+ cells (flowcytometry)	3 days after enrollment
Primary	Innate immune response to SARS-Cov-2	Measurement of HLA-DR expression on CD14+ cells (flowcytometry)	5 days after enrollment
Primary	Humoral immune response	Measurement of neutralizing SARS-Cov-2 antibody concentrations (plaque reduction assay)	At enrollment
Primary	Cell mediated immune response	Measurement of frequencies of SARS-Cov-2 specific T-cells (ELISPOT assay)	At enrollment
Primary	Cell mediated immune response	Measurement of frequencies of SARS-Cov-2 specific T-cells (ELISPOT assay)	28 days (+/-7) after enrollment
Primary	Neurological damage	Measurement of neurofilament light chains in serum (on ELLA platform; Protein Simple, Bio-techne)	At enrollment
Primary	Neurological damage	Measurement of neurofilament light chains in serum (on ELLA platform; Protein Simple, Bio-techne)	28 days (+/-7) after enrollment
Secondary	Complement activation	Measurement of factor B, factor H, factor I, C3a, C4a, C5a, SC5b9	At enrollment
Secondary	Complement activation	Measurement of factor B, factor H, factor I, C3a, C4a, C5a, SC5b9	28 days (+/-7) after enrollment