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NCT Number: NCT04510012

Characterizing the Immune Response and Neuronal Damage in COVID-19

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.

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Key information

Conditions

SARS-CoV Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Inflammation Lung Diseases Nervous System Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Trauma, Nervous System Virus Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bern University Hospital

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PCR confirmed SARS-Cov-2 infection

Exclusion criteria

  • Refusal to participate
  • Age < 18 years

Treatment and study plan

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

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • University of Bern

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Aug 12, 2020
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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