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Characterizing the Immune Response and Neuronal Damage in COVID-19

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ClinicalTrials.gov Identifier: NCT04510012
Recruitment Status : Unknown
Verified August 2020 by University Hospital Inselspital, Berne.
Recruitment status was:  Recruiting
First Posted : August 12, 2020
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
University of Bern
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment
SARS-CoV Infection Covid-19 Other: Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.

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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterizing the Immune Response and Neuronal Damage in SARS-CoV-2 Infected Individuals
Actual Study Start Date : March 5, 2020
Estimated Primary Completion Date : March 5, 2021
Estimated Study Completion Date : March 5, 2021


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. Innate immune response to SARS-Cov-2 [ Time Frame: At enrollment ]
    Measurement of HLA-DR expression on CD14+ cells (flowcytometry)

  4. Innate immune response to SARS-Cov-2 [ Time Frame: 3 days after enrollment ]
    Measurement of HLA-DR expression on CD14+ cells (flowcytometry)

  5. Innate immune response to SARS-Cov-2 [ Time Frame: 5 days after enrollment ]
    Measurement of HLA-DR expression on CD14+ cells (flowcytometry)

  6. Humoral immune response [ Time Frame: At enrollment ]
    Measurement of neutralizing SARS-Cov-2 antibody concentrations (plaque reduction assay)

  7. Cell mediated immune response [ Time Frame: At enrollment ]
    Measurement of frequencies of SARS-Cov-2 specific T-cells (ELISPOT assay)

  8. Cell mediated immune response [ Time Frame: 28 days (+/-7) after enrollment ]
    Measurement of frequencies of SARS-Cov-2 specific T-cells (ELISPOT assay)

  9. Neurological damage [ Time Frame: At enrollment ]
    Measurement of neurofilament light chains in serum (on ELLA platform; Protein Simple, Bio-techne)

  10. Neurological damage [ Time Frame: 28 days (+/-7) after enrollment ]
    Measurement of neurofilament light chains in serum (on ELLA platform; Protein Simple, Bio-techne)


Secondary Outcome Measures :
  1. Complement activation [ Time Frame: At enrollment ]
    Measurement of factor B, factor H, factor I, C3a, C4a, C5a, SC5b9

  2. Complement activation [ Time Frame: 28 days (+/-7) after enrollment ]
    Measurement of factor B, factor H, factor I, C3a, C4a, C5a, SC5b9


Biospecimen Retention:   Samples Without DNA
Serum, Plasma, Peripheral Blood Mononuclear Cells


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult (≤ 18 years) patients with PCR confirmed SARS-Cov-2 infection
Criteria

Inclusion Criteria:

  • PCR confirmed SARS-Cov-2 infection

Exclusion Criteria:

  • Refusal to participate
  • Age < 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510012


Contacts
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Contact: Cédric Hirzel, MD +41316640117 cedric.hirzel@insel.ch

Locations
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Switzerland
Bern University Hospital Recruiting
Bern, Switzerland, 3010
Contact: Cédric Hirzel, MD    +41316640117    cedric.hirzel@insel.ch   
Sub-Investigator: Ronald Dijkman, PhD         
Sub-Investigator: Thibaud Spinetti, PhD         
Sub-Investigator: Franziska Suter, PhD         
Sub-Investigator: Denis Grandgirard, PhD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
Investigators
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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
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04510012    
Other Study ID Numbers: nCOV19
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
Innate immune response
Adaptive immune response
Inflammation
Neurological damage
Additional relevant MeSH terms:
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COVID-19
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Complement System Proteins
Immunologic Factors
Physiological Effects of Drugs