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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Severe Acute Respiratory Syndrome; SARS Virus
• Intervention / Treatment: Diagnostic test: SARS-CoV-2 PCR

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Jan C Holter, PhD; Phone Number: +4723071155 +4791195761; Email: jacaho@ous-hf.no
• Study Contact Backup: Name: Susanne G Dudman, PhD; Phone Number: +4723071155 +4723071155; Email: Susanne.Dudman@ous-hf.no

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Recruiting
    • Haukeland University Hospital
    • Contact: Bjørn Blomberg, PhD
  • Fredrikstad, Norway, 1714
    • Recruiting
    • Østfold Hospital Trust
    • Contact: Jonas Bergan, phd
  • Lørenskog, Norway, 1478
    • Recruiting
    • Akershus University Hospital
    • Contact: Christian Prebensen, PhD
  • Oslo, Norway, 0424
    • Recruiting
    • Oslo University Hospital
    • Contact: Jan C Holter, PhD; Phone Number: +4791195761 +4791195761; Email: jacaho@ous-hf.no
    • Contact: Susanne G Dudman, Ass.Professor; Phone Number: +4791195761 +4791195761; Email: Susanne.Dudman@ous-hf.no
  • Tromsø, Norway, 9019
    • Recruiting
    • University Hospital North Norway
    • Contact: Anders B Kildal, PhD
  • Trondheim, Norway, 7030
    • Recruiting
    • St Olavs hospital
    • Contact: Erik Solligård, PhD
  • Viken
    • Drammen, Viken, Norway, 3000
      • Recruiting
      • Vestre Viken Drammen Hospital
      • Contact: Lars Heggelund, PhD
      • Contact: Email: Lars.Heggelund@vestreviken.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients admitted to Oslo University Hospital, Vestre Viken Drammen Hospital, Akershus University Hospital or Østfold Hospital Kalnes will be recruited consecutively after testing positive for SARS-CoV-2

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Refusal of consent by patient or closest relative

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clearance of SARS-CoV-2 from respiratory specimen	The change in(clearance of) viral RNA measured by polymerase chain reaction assay (PCR) test at days 1, 3, 8,14 and 90 days	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
Immune response to COVID-19	Cell-mediated and humoral immunity	From date of randomization until the date of clinical follow-up assessed up to 3 months.

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Vestre Viken Hospital Trust; University Hospital of North Norway; Ostfold Hospital Trust; Haukeland University Hospital; St. Olavs Hospital; University Hospital, Akershus
• Investigators: Study Director: Fredrik G Müller, Professor, University of Oslo; Study Chair: Susanne G Dudman, Professor, University of Oslo; Principal Investigator: Jan C Holter, PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (Actual): May 11, 2020

Study Record Updates

• Last Update Posted (Actual): May 11, 2020
• Last Update Submitted That Met QC Criteria: May 8, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Severe Acute Respiratory Syndrome
• Other Study ID Numbers: 20-04072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No