Nasal and Pulmonary Nitric Oxide Output in COVID-19 Infection
试验速览
- 阶段
- 不适用
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Viral load of SARS-CoV-2 from different sample sites
研究概览
简要总结
A Study of the relation of COVID-19 infection and its severity to upper and lower airway nitric oxide, upper airway viral load and lung function.
详细描述
Materials and methods
Prospective cohort of 40 COVID-19, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), positive patients from Tampere university hospital region are recruited to the study. Forty COVID-19 negative patients with similar symptoms act as a control group.
All subjects are screened for other respiratory viruses with reverse transcriptase polymerase chain reaction (RT-PCR)-multiplex tests. Viral loads of SARS-CoV-2 from anterior nasal cavity, nasopharynx, throat and saliva are evaluated by RT-PCR cycle treshold (Ct) value and antigen testing (RLU value).
During the first visit NEWS (National Early Warning Score), recorded pulmonary auscultation (Thinklabs One, Thinklabs Medical LLC), impulse oscillometry (Tremoflo, THORASYS Thoracic Medical Systems Inc), FeNO (fractional exhaled nitric oxide) and FnNO (fractional nasal nitric oxide) (NIOX VERO®,Circassia) are conducted. All aforementioned and a spirometry are measured again after 2 months.
Aims: To evaluate the relation of COVID-19 infection and its severity to upper and lower airway nitric oxide, viral load and lung function. To compare the capability of RT-PCR in detecting SARS-CoV-2 RNA from saliva, anterior nasal swab samples and oropharyngeal swap samples vs. the golden standard of nasopharyngeal swab samples. To compare the results of RT-PCR and antigen test in detecting SARS-CoV-2 from nasal and pharyngeal sample sites.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •capable of breathing through nose, no need of supplemental oxygen, symptom onset within 10 days, positive SARS-CoV-2 test in Fimlab and capable of performing all required tests
排除标准
- •need of supplemental oxygen, pregnancy, lactation, incapability of performing the tests for any reason, use of organic nitrate medication
结局指标
主要结局
Viral load of SARS-CoV-2 from different sample sites
时间窗: 0 months
RT-PCR (Ct value) and antigen testing (RLU value)
FnNO
时间窗: 2 months
Nasal nitric oxide in ppb obtained NIOX VERO
Change in FeNO
时间窗: BAseline and at 2 months
FeNO at 2 months - FeNO at baseline
Change in R20
时间窗: Baseline and at 2 months
R20 at 2 months - R20 at baseline
Upper respiratory tract viruses
时间窗: 0 months
RT-PCR-multiplex tests, from nasopharyngeal sample site
FeNO
时间窗: 2 months
Fractional exhaled nitric oxide in ppb obtained NIOX VERO
Airway resistance at 5Hz, R5
时间窗: 2 months
Airway resistance at 5Hz obtained from Impulse oscillometry
CHange in FnNO
时间窗: Baseline and at 2 months
FnNO at 2 moths - FnNO at baseline
Airway resistance at 20Hz, R20
时间窗: Baseline
Airway resistance at 20Hz obtained from Impulse oscillometry
Airway resistance at 20 Hz, R20
时间窗: 2 months
Airway resistance at 20 Hz obtained from Impulse oscillometry
Change in R5
时间窗: Baseline and at 2 months
R5 at 2 months - R5 at baseline
Reactance at 5Hz (X5)
时间窗: 2 months
Airway reactance at 5 Hz obtained from Impulse oscillometry
Resonant frequency (Fres)
时间窗: 2 months
Resonant frequency (Fres) obtained from Impulse oscillometry
Change in X5
时间窗: Baseline and at 2 months
X5 at 2 months - X5 at baseline
Change in Fres
时间窗: Baseline and at 2 months
Fres at 2 months - Fres at baseline
Reactance area (AХ)
时间窗: 2 months
Reactance area (AХ) obtained from Impulse oscillometry
Change in AX
时间窗: Baseline and at 2 months
AX at 2 months - AX at baseline
次要结局
- FVC(2 months)
- FEV1/VC(2 months)
- FEV1(2 months)
- VC(2 months)
- FEV1/FVC(2 months)
研究者
Lauri Lehtimäki
associate professor
Tampere University Hospital