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

• Sponsor: Oslo University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04381819
• Collaborator: University Hospital, Akershus (Other), Vestre Viken Hospital Trust (Other), Ostfold Hospital Trust (Other), Haukeland University Hospital (Other), University Hospital of North Norway (Other), St. Olavs Hospital (Other)
• Enrollment: 1,000
• Locations: 7
• Anticipated Duration (Months): 46
• Patients Per Site: 142.9
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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	Phase
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.

Study Design

• Study Type: Observational
• Anticipated 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: Mar 2, 2020
• Anticipated Primary Completion Date: Feb 28, 2022
• Anticipated Study Completion Date: Dec 31, 2023

Outcome Measures

Primary Outcome Measures

1. Death [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 [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 [30 days]

   Percentage of patients requiring intensive care admission or ventilation

Secondary Outcome Measures

1. Clearance of SARS-CoV-2 from respiratory specimen [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 [From date of randomization until the date of clinical follow-up assessed up to 3 months.]

   Cell-mediated and humoral immunity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Refusal of consent by patient or closest relative

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vestre Viken Drammen Hospital	Drammen	Viken	Norway	3000
2	Haukeland University Hospital	Bergen		Norway	5021
3	Østfold Hospital Trust	Fredrikstad		Norway	1714
4	Akershus University Hospital	Lørenskog		Norway	1478
5	Oslo University Hospital	Oslo		Norway	0424
6	University Hospital North Norway	Tromsø		Norway	9019
7	St Olavs Hospital	Trondheim		Norway	7030

Sponsors and Collaborators

• Oslo University Hospital
• University Hospital, Akershus
• Vestre Viken Hospital Trust
• Ostfold Hospital Trust
• Haukeland University Hospital
• University Hospital of North Norway
• St. Olavs Hospital

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• Last Update Posted: May 11, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Severe Acute Respiratory Syndrome

Study Results

No Results Posted as of May 11, 2020