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

Study Overview
=================
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.

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

Conditions
-----------------
SARS Virus, Severe Acute Respiratory Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: SARS-CoV-2 PCR


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: SARS-CoV-2 PCR|SARS-CoV-2 E gene|

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. |