Dynamics of Nucleocapsid Antigen Serum Levels and Other Markers of Infection and Inflammation in Hospitalized Coronavirus Disease 2019 (COVID-19) Patients - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Prediction of severity of lung dysfunction based on initial interleukin-6 serum levels
研究概览
简要总结
Patients requiring admission to the hospital due to a moderate and severe COVID-19 infection may differ in their ability to respond to viral infection and to eliminate viral load.
Several comorbidities and interventions like antivirotic or antiinflammatory treatment may also modify expected patients response and decrease of viral load.
In this observational study, evolution of selected inflammatory markers, indicators of severity of infection and patient characteristics will be followed and recorded in hospitalized patients with COVID-19.
详细描述
In this pilot study, 30 consecutive COVID-19 patients requiring admission to the hospital due to a moderate and severe COVID-19 infection will be included into an observational study.
Following parameters will be recorded: age, sex, weight, height, comorbidities, smoking habit,spiritus and drug intake history, length of COVID-19 symptoms, clinical and laboratory parameters, the use of different COVID-19 intervention (remdesivir, convalescent plasma, monoclonal antibodies, corticosteroids, tocilizumab and other medication), used initial and maximal organ support during the stay and outcome of the stay in the hospital and 28th and 90th day, laboratory markers of severity of infection - serum and tracheal aspirate (in ventilated patients) levels of nucleocapsid antigen,Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2) viremia and quantity in tracheal aspirates (in ventilated patients), makers of inflammatory response (C- reactive proteins, Interleukin 6, procalcitonin, ferritin) and selected other biochemical values (blood count, D-dimers, flow cytometry).
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SARS CoV2 positive test within last 14 day
- •bilateral infiltrates on chest X.ray or CT
- •need for oxygen to keep pulse oximetry saturation above 92% or other respiratory support measures (HFNO, non-invasive ventilation or invasive ventilation)
排除标准
- •known history of intersticial lung disease
- •known history of congestive heart failure
结局指标
主要结局
Prediction of severity of lung dysfunction based on initial interleukin-6 serum levels
时间窗: Admission
Correlation between baseline interleukin -6 serum levels and Ordinal Scale for Clinical Improvement
Prediction of severity of lung dysfunction based on initial nucleocapsid antigen serum levels
时间窗: Admission
Correlation between baseline nucleocapsid serum levels and the Ordinal Scale for Clinical Improvement
Prediction of severity of lung dysfunction based on
时间窗: Admission
Correlation between baseline CRP serum levels and Ordinal Scale for Clinical Improvement
次要结局
- Effect of age on persistence of tracheal viral load assessed using tracheal aspirate semiquantitative PCR(up to 28 days)
- Effect of age on viral load assesed using nucleocapsid antigen serum levels(up to 28 days)
- Effect of comorbidities on persistence of tracheal viral load assessed using tracheal aspirate semiquantitative PCR(up to 28 days)
- Effect of the remdesivir on the nucleocapsid antigen serum levels(up to 28 days)
- Tracheal viral load quantification using tracheal nucleocapsid antigen(up to 28 days)
- Effect of the dose of corticosteroids on the nucleocapsid antigen serum levels(up to 28 days)
- Effect of comorbidities on viral load assessed using nucleocapsid antigen serum levels(up to 28 days)
研究者
Dostalova Vlasta, MD, PhD
principal investigator
University Hospital Hradec Kralove