NCT05351385招募中不适用
S Protein and COVID-19: a Monocentric Prospective Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Plasma PROS levels compared to early stage of SARS-CoV-2 infection.
研究概览
简要总结
The aim of this study is to compare plasma S Protein levels to SARS-CoV-2 viral load in COVID positive patients.
详细描述
Non-pharmacological, non-interventional, prospective, monocentric study involving the use of biological materials.
There will be two cohorts:
- COVID + cohort: 50 patients with positive nasopharyngeal swab and / or BAL.
- Control Cohort: 20 patients with non-SARS-CoV-2 related pneumonia.
The study involves analyzing biological samples collected for normal clinical practice.
In particular:
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
- •Cohort COVID + :
- •Subjects aged ≥ 18 years.
- •Signing of the informed consent.
- •Positivity for SARS-CoV-2 by RealTimePCR from nasopharyngeal swab or bronchial wash.
- •Cohort Control:
- •Subjects aged ≥ 18 years.
- •Signing of the informed consent.
- •Diagnosis of pneumonia not related to SARS-CoV-2, demonstrated by negative swab.
排除标准
- •Patients with a diagnosis of congenital S Protein deficiency.
- •Patients who are taking oral anticoagulant therapy (TAO) or new oral anticoagulants (NAO).
- •Chronic liver failure (> 5 points on the Child-Pugh score).
- •Female subjects who are pregnant or on estrogen-progestogen replacement therapy.
结局指标
主要结局
Plasma PROS levels compared to early stage of SARS-CoV-2 infection.
时间窗: Day +15
To demonstrate a correlation between low plasma PROS levels and the early stage of SARS-CoV-2 infection, defined as the first 10 days after onset of symptoms.
Plasma PROS level compared to SARS-Cov-2 viral load
时间窗: Day+15
To demonstrate a correlation between PROS and the viral load of SARS-CoV-2
次要结局
- Normal levels Plasma S potein in late stage of SARS-CoV-2 infection in COVID + patients.(Day 0, Day +5, Day +10, Day+15)
- Normal plasma protein S levels in patients with Pneumonia non-SARS-CoV related(Day 0, Day +5)
- Plasma protein S as an index for use of immunosuppressive therapy.(Day 0, Day +5, Day +10, Day+15)
- Correlation between plasma levels of S protein and the severity indices of SARS-CoV-2 disease(Day 0, Day +5, Day +10, Day+15)
研究者
研究点 (1)
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