Clinical trial NCT04510012: Characterizing the Immune Response and Neuronal Damage in COVID-19
Official title: Characterizing the Immune Response and Neuronal Damage in SARS-CoV-2 Infected Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV Infection
Covid-19
Keywords: Innate immune response
Adaptive immune response
Inflammation
Neurological damage
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2020-08-12
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult (≤ 18 years) patients with PCR confirmed SARS-Cov-2 infection

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.

Eligibility criteria: Inclusion Criteria:

* PCR confirmed SARS-Cov-2 infection

Exclusion Criteria:

* Refusal to participate
* Age \< 18 years

Primary outcomes:
measure: Cytokine response to SARS-Cov-2
timeFrame: At enrollment
measure: Cytokine response to SARS-Cov-2
timeFrame: 28 days (+/-7) after enrollment
measure: Innate immune response to SARS-Cov-2
timeFrame: At enrollment
measure: Innate immune response to SARS-Cov-2
timeFrame: 3 days after enrollment
measure: Innate immune response to SARS-Cov-2
timeFrame: 5 days after enrollment
measure: Humoral immune response
timeFrame: At enrollment
measure: Cell mediated immune response
timeFrame: At enrollment
measure: Cell mediated immune response
timeFrame: 28 days (+/-7) after enrollment
measure: Neurological damage
timeFrame: At enrollment
measure: Neurological damage
timeFrame: 28 days (+/-7) after enrollment
Secondary outcomes:
measure: Complement activation
timeFrame: At enrollment
measure: Complement activation
timeFrame: 28 days (+/-7) after enrollment
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Bern University Hospital
Study officials:
affiliation: Department of Infectious Diseases, Bern University Hospital, Bern, Switzerland
name: Cédric Hirzel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Infectious Diseases; Bern University
name: Leib L Stephen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland
name: Jörg C Schefold, MD
role: PRINCIPAL_INVESTIGATOR
References: