COVID-19 RELATED SUBMISSION: VEGF and sFlt-1 Levels in the Pathogenesis and Severity of COVID-19 Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- PlGF
研究概览
简要总结
To assess blood levels of vasoactive mediators that may regulate pulmonary endothelial permeability and contribute to multi-organ injury in patients with COVID-19 disease and to correlate the levels of these mediators with disease outcomes such as ICU admission, length of ventilatory support, respiratory failure, kidney failure, heart failure, and death.
详细描述
When patients are sick with other lung infections (pneumonias) caused by viruses or bacteria there are changes in a pathway that regulates the "leakiness" the tiny airspaces inside the lungs. Even bigger changes in this pathway are seen when patients develop severe breathing difficulties (acute respiratory distress syndrome) similar to what is seen in patients who get really sick with COVID-19 disease.
There are important changes in this pathway that occur in patients who have preexisting cardiovascular (heart) disease who do not have lung infections. The investigator will evaluate these levels in patients with COVID-19 because the investigator believes that this baseline difference in pathway regulation may be one reason patients with heart disease who contract COVID-19 get sicker than patients without heart or vascular disease.
The investigator will also assess the levels of components of this pathway in patients who are less sick with those who became sick enough to require a tube to help them breathe because this is important to determine if COVID-19 lung disease has a similar effect on this pathway as other lung infections like flu and bacterial pneumonias.
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
- •Positive test for COVID-19 (SARS-CoV-2 infection)
- •>=18 years
- •Blood (plasma) specimen(s) available in the CCTS biorepository
排除标准
- •<18 years
- •Lack of blood specimen
结局指标
主要结局
PlGF
时间窗: 7-14 days after symptom onset
Plasma samples will be analyzed to measure PlGF
FGF
时间窗: 7-14 days after symptom onset
Plasma samples will be analyzed to measure FGF
Laboratory Assays
时间窗: 7-14 days after symptom onset
The primary outcome measure is the ratio of soluble fms-like tyrosine kinase receptor-1 (sFlt-1) to vascular endothelial growth factor (VEGF) which will be obtained using an immunoassay on blood samples. The specimens will be analyzed using enzyme-linked immunosorbent assay and reported as a ratio
VEGF-A
时间窗: 7-14 days after symptom onset
Plasma samples will be analyzed to measure VEGF-A
Tie-2
时间窗: 7-14 days after symptom onset
Plasma samples will be analyzed to measure Tie-2
VEGF-D
时间窗: 7-14 days after symptom onset
Plasma samples will be analyzed to measure VEGF-D
Flt-1
时间窗: 7-14 days after symptom onset
Plasma samples will be analyzed to measure Flt-1
VEGF-C
时间窗: 7-14 days after symptom onset
Plasma samples will be analyzed to measure VEGF-C
次要结局
未报告次要终点
研究者
Dylan R. Addis, MD
Principal Investigator
University of Alabama at Birmingham