Norwegian SARS-CoV-2 Study - Virological, Clinical and Immunological Characterisation of Inpatients During the COVID-19 Outbreak: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 7
- 主要终点
- Death
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed COVID-19 by screening of SARS-CoV-2 E-gene
排除标准
- •Refusal of consent by patient or closest relative
结局指标
主要结局
Death
时间窗: From date of randomization until the date of death from any cause assessed up to 3 months.
Fatal outcome from COVID-19
Recovery from COVID-19
时间窗: From date of randomization until the date of recovery from COVID-19 symptoms assessed up to 3 months.
Resolved infection
Progression to ICU care or ventilation
时间窗: 30 days
Percentage of patients requiring intensive care admission or ventilation
次要结局
- Immune response to COVID-19(From date of randomization until the date of clinical follow-up assessed up to 3 months.)
- 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)
研究者
Jan Cato Holter
Project leader, medical doctor, PhD
Oslo University Hospital
