A Multi-Center Study Evaluating Clinical Course in Patients With COVID-19 and Its Relationship to Cytokine Storm
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Clinical Outcomes of Patients with COVID-19 using the National Early Warning Score 2 (NEWS2) system
研究概览
简要总结
This is a multi-center study comparing clinical outcomes in patients with COVID-19 in subjects hospitalized at Hadassah and other hospitals for PCR or serology confirmed COVID-19 and compare the outcomes to the presence of different degrees of a cytokine storm. The patients will be subdivided into a mild, moderate, and severe course according to NEWS2.
详细描述
Study Rationale
Over 100 patients were hospitalized at Hadassah in the recent 2 months with the diagnosis of COVID-19.
We would like to summarize the clinical outcomes and their correlation to a cytokine storm at Hadassah and additional hospitals and additional hospitals in Israel.
COVID-19, the name given to the clinical syndrome associated with the newly recognized virus SARS-CoV-2 has become pandemic with a mortality estimated based on reports from China between 1-3% and complications among hospitalized patients leading to up to 15-25% admissions to the ICU.
The clinical presentation includes both upper and lower respiratory tract infection, but patients may also be asymptomatic.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Patients, male or female of any age diagnosed with COVID-19, as defined below:
- •Laboratory confirmation of SARS-CoV-2 infection by reverse transcription-polymerase chain reaction (RT-PCR) from any diagnostic sampling source.
- •Serological evidence of SARS-CoV-2 infection
排除标准
- 未提供
结局指标
主要结局
Clinical Outcomes of Patients with COVID-19 using the National Early Warning Score 2 (NEWS2) system
时间窗: 6 months
To compare the clinical outcomes of patients with COVID-19 to Sepsis and CAR-T-related cytokine storm. This will be done by assessment of acute-illness severity using the NEWS2 scoring system (Higher scores mean more severe illness)
Mortality
时间窗: 6 months
Incidence rate of Mortality from any cause
Clinical Outcomes of Patients with COVID-19 using the new NIH Patient Classification of severity of illness
时间窗: 6 months
To compare the clinical outcomes of patients with COVID-19 to Sepsis and CAR-T-related cytokine storm. This will be done by assessment of acute-illness severity using the new NIH Patient Classification to (1) Asymptomatic or Pre-symptomatic Infection; (2) Mild Illness; (3) Moderate Illness; (4) Severe Illness; (5) Critical Illness As detailed in the Study design section.
Cytokine/Chemokine/Hematopoietic Growth Factors/ Complement and Other Immune Modulators in Patients with COVID-19
时间窗: 6 months
To assess cytokine/chemokine/hematopoietic growth factors/ Complement and other immune modulators in patients with COVID-19 by measuring the serum concentrations of these factors in COVID-19 patients and compare those the levels of patients with sepsis and CAR T cytokine release syndrome.
次要结局
未报告次要终点
研究者
Mevorach Dror
Professor & Head, Department of Internal Medicine B; Head, Rheumatology Research Center, Hadassah and the Hebrew University Medical School
Hadassah Medical Organization