Clinical trial NCT04381819: Norwegian SARS-CoV-2 Study - Virological, Clinical and Immunological Characterisation of COVID-19
Official title: Norwegian SARS-CoV-2 Study - Virological, Clinical and Immunological Characterisation of Inpatients During the COVID-19 Outbreak: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS Virus
Severe Acute Respiratory Syndrome
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Akershus
name: Vestre Viken Hospital Trust
name: Ostfold Hospital Trust
name: Haukeland University Hospital
name: University Hospital of North Norway
name: St. Olavs Hospital
First posted: 2020-05-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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).

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Refusal of consent by patient or closest relative

Primary outcomes:
measure: Death
timeFrame: From date of randomization until the date of death from any cause assessed up to 3 months.
measure: Recovery from COVID-19
timeFrame: From date of randomization until the date of recovery from COVID-19 symptoms assessed up to 3 months.
measure: Progression to ICU care or ventilation
timeFrame: 30 days
Secondary outcomes:
measure: Clearance of SARS-CoV-2 from respiratory specimen
timeFrame: 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
measure: Immune response to COVID-19
timeFrame: From date of randomization until the date of clinical follow-up assessed up to 3 months.
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Vestre Viken Drammen Hospital
state: Viken
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Fredrikstad
country: Norway
facility: Østfold Hospital Trust
city: Lørenskog
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Tromsø
country: Norway
facility: University Hospital North Norway
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: University of Oslo
name: Fredrik G Müller, Professor
role: STUDY_DIRECTOR
affiliation: University of Oslo
name: Susanne G Dudman, Professor
role: STUDY_CHAIR
affiliation: Oslo University Hospital
name: Jan C Holter, PhD
role: PRINCIPAL_INVESTIGATOR
References: