跳至主要内容
临床试验/NCT04524156
NCT04524156Unknown不适用

COVID-19 : Transcutaneous pO2 and pCO2 as Predictive Factors for Acute Respiratory Destress Syndrome in Patients Affected With SARS-Cov-2

Erasme University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年10月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Transcutaneous pO2 and pCO2 as predictive factors for respiratory deterioration

研究概览

简要总结

The first case of a person infected with SARS-Cov-2 virus can be tracked back on November the 17th, 2019, in China. On March 11, 2020, the World Health Organization (WHO) declared COVID-19 outbreak a pandemic. On April 13, COVID-19 is affecting 210 countries and territories worldwide, about 2 million positive cases have been officially declared along with 115.000 deaths. The real number of infected and deaths is scarily higher, considering that up to 65% people are asymptomatic and thus, not tested.

The percentage of patients with COVID-19 needed for intensive care unit (ICU) varied from 5 to 32% in Wuhan, China. It was up to 9% in Lombardy, Italy. According to available data from Lombardy, 99% of patients admitted to the ICU needed respiratory support (88% invasive ventilation, 11% non invasive ventilation).

The aim of the present investigation is to test the hypothesis whether transcutaneous partial O2 and CO2 pressures may be reliable predictive factors for acute respiratory distress syndrome (ARDS) development in hospitalized clinically stable COVID-19 positive patients and to clarify the role of the Angiotensin Converting Enzyme 2 (ACE2) and its final product, angiotensin 2 (Ang II) in the pathogenesis of this systemic disease.

We also aim to test the hypothesis that plasma concentration of Clara Cell protein (CC16) and surfactant protein D (SPD), which are a biomarkers of acute lung injury, are severely decreased in COVID-19 positive patients and the plasma concentration is related to the severity of lung injury.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

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

  • •SARS-CoV2 infection (PCR positive and/or TDM Imaging)

排除标准

  • 未提供

研究组 & 干预措施

COVIS 19 positive

Active Comparator

干预措施: Physiology (Other)

COVID 19 negative

Sham Comparator

干预措施: Physiology (Other)

结局指标

主要结局

Transcutaneous pO2 and pCO2 as predictive factors for respiratory deterioration

时间窗: 6 months

To test the prognostic utility of TcpO2 and TcpCO2 for the prediction of COVID19 related lung injury and acute respiratory distress syndrome (ARDS) compared to finger oxygen saturation.

Pneumoproteins CC16 and SDP as predictive factors for respiratory deterioration

时间窗: 6 months

To test the prognostic utility of CC16 and SPD in patients with COVID19-related acute lung injury

Diagnostic and prognostic utility of plasma concentration of ACE2, Ang II, Ang 1-7, Ang 1-9 in COVID-19

时间窗: 6 months

To test the hypothesis that plasma concentration of ACE2, AngII, Ang 1-7 and Ang 1-9 are profoundly impaired in COVID-19 and may be predictive factors of clinical deterioration

次要结局

未报告次要终点

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验