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

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ClinicalTrials.gov Identifier: NCT04381819
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : May 11, 2020
Sponsor:
Collaborators:
University Hospital, Akershus
Vestre Viken Hospital Trust
Østfold Hospital Trust
Haukeland University Hospital
University Hospital of North Norway
St. Olavs Hospital
Information provided by (Responsible Party):
Jan Cato Holter, Oslo University Hospital

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).

Condition or disease Intervention/treatment
SARS Virus Severe Acute Respiratory Syndrome 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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Norwegian SARS-CoV-2 Study - Virological, Clinical and Immunological Characterisation of Inpatients During the COVID-19 Outbreak: A Prospective Cohort Study
Actual Study Start Date : March 2, 2020
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. 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

  2. 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

  3. Progression to ICU care or ventilation [ Time Frame: 30 days ]
    Percentage of patients requiring intensive care admission or ventilation


Secondary Outcome Measures :
  1. 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

  2. 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


Biospecimen Retention:   Samples With DNA
Respiratory secretions, blood, urine, stool, cerebrospinal fluid


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal of consent by patient or closest relative

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04381819


Contacts
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Contact: Jan C Holter, PhD +4791195761 ext +4723071155 jacaho@ous-hf.no
Contact: Susanne G Dudman, PhD +4723071155 ext +4723071155 Susanne.Dudman@ous-hf.no

Locations
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Norway
Vestre Viken Drammen Hospital Recruiting
Drammen, Viken, Norway, 3000
Contact: Lars Heggelund, PhD         
Contact       Lars.Heggelund@vestreviken.no   
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Bjørn Blomberg, PhD         
Østfold Hospital Trust Recruiting
Fredrikstad, Norway, 1714
Contact: Jonas Bergan, phd         
Akershus University Hospital Recruiting
Lørenskog, Norway, 1478
Contact: Christian Prebensen, PhD         
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Jan C Holter, PhD    +4791195761 ext +4791195761    jacaho@ous-hf.no   
Contact: Susanne G Dudman, Ass.Professor    +4791195761 ext +4791195761    Susanne.Dudman@ous-hf.no   
University Hospital North Norway Recruiting
Tromsø, Norway, 9019
Contact: Anders B Kildal, PhD         
St Olavs Hospital Recruiting
Trondheim, Norway, 7030
Contact: Erik Solligård, PhD         
Sponsors and Collaborators
Oslo University Hospital
University Hospital, Akershus
Vestre Viken Hospital Trust
Østfold Hospital Trust
Haukeland University Hospital
University Hospital of North Norway
St. Olavs Hospital
Investigators
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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
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Responsible Party: Jan Cato Holter, Project leader, medical doctor, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04381819    
Other Study ID Numbers: 20-04072
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases