Norwegian SARS-CoV-2 Study – Virological, Clinical and Immunological Characterisation of COVID-19

Overview

Oslo University Hospital has initiated an observational study on hospitalised patients with confirmed COVID-19, the infection caused by Severe Acute Respiratory Syndrome Coronavirus type 2 (SARS-CoV-2).

Full Title of Study: “Norwegian SARS-CoV-2 Study – Virological, Clinical and Immunological Characterisation of Inpatients During the COVID-19 Outbreak: A Prospective Cohort Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 28, 2022

Detailed Description

Infectious disease is the single biggest cause of death worldwide. New infectious agents, such as the SARS-CoV-2, require investigation to understand pathogen biology and pathogenesis in the host. In order to develop a mechanistic understanding of disease processes, such that risk factors for severe illness can be identified and treatments can be developed, it is necessary to understand pathogen characteristics associated with virulence, the replication dynamics and in-host evolution of the pathogen, the dynamics of the host response, the pharmacology of antimicrobial or host directed therapies, the transmission dynamics, and factors underlying individual susceptibility. At Oslo University Hospital, an observational study on the newly discovered emerging SARS- CoV-2, the coronavirus that causes COVID-19 infection has started. The study has been approved by the Regional Ethics Committee, so that inclusion of confirmed COVID-19 cases admitted at the hospital can start immediately including the first patients needing hospitalisation. The plan is to include more hospitals in other parts of Norway, starting with inclusion of Akershus University Hospital, Vestre Viken Drammen Hospital and Østfold Hospital. The study is anticipated to provide much needed data on the course of the COVID-19 infection, as well as generating knowledge about the virus and its transmission.

Interventions

  • Diagnostic Test: SARS-CoV-2 PCR
    • SARS-CoV-2 E gene

Clinical Trial Outcome Measures

Primary Measures

  • Death
    • Time Frame: From date of randomization until the date of death from any cause assessed up to 3 months.
    • Fatal outcome from COVID-19
  • Recovery from COVID-19
    • Time Frame: From date of randomization until the date of recovery from COVID-19 symptoms assessed up to 3 months.
    • Resolved infection
  • Progression to ICU care or ventilation
    • Time Frame: 30 days
    • Percentage of patients requiring intensive care admission or ventilation

Secondary Measures

  • Clearance of SARS-CoV-2 from respiratory specimen
    • Time Frame: The number of calendar days from date of PCR positive test (counted as 1 day) in respiratory specimen until date of such test first become negative in the respiratory specimen assessed up to 3 months
    • The change in(clearance of) viral RNA measured by polymerase chain reaction assay (PCR) test at days 1, 3, 8,14 and 90 days
  • Immune response to COVID-19
    • Time Frame: From date of randomization until the date of clinical follow-up assessed up to 3 months.
    • Cell-mediated and humoral immunity

Participating in This Clinical Trial

Inclusion Criteria

  • Confirmed COVID-19 by screening of SARS-CoV-2 E-gene Exclusion Criteria:

  • Refusal of consent by patient or closest relative

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Oslo University Hospital
  • Collaborator
    • University Hospital, Akershus
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jan Cato Holter, Project leader, medical doctor, PhD – Oslo University Hospital
  • Overall Official(s)
    • Fredrik G Müller, Professor, Study Director, University of Oslo
    • Susanne G Dudman, Professor, Study Chair, University of Oslo
    • Jan C Holter, PhD, Principal Investigator, Oslo University Hospital
  • Overall Contact(s)
    • Jan C Holter, PhD, +4791195761, jacaho@ous-hf.no

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