Prospective Longitudinal Study to Characterize and Understand the Clinical Relevance of SARS-CoV2 Related Ventilation and Perfusion Injury Evaluated by V/Q SPECT-CT in an Asthmatic and Healthy Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Short-term difference in perfusion defect percent assessed by perfusion SPECT-CT - healthy
研究概览
简要总结
Little is currently known about the immediate and long-term effect of COVID-19 on lung ventilation (delivery of air to the lungs) and lung perfusion (delivery of blood to the lungs). Some people who survive COVID-19 may have lung ventilation and/or perfusion injury that persists following COVID-19 recovery. This lung injury may be related to inflammation in the lung, breathlessness, exercise limitation and reduced quality of life. Therefore, towards the goal of understanding the effects of COVID-19 on lung health, the purpose of this study is to characterize and understand the clinical relevance of COVID-19 related lung ventilation and perfusion injury and associated inflammatory status, ≤4 weeks and 6-months following COVID-19 recovery in an asthmatic and healthy population. To do this, an asthmatic and healthy population who have, and have not, been previously diagnosed with COVID-19 will be studied.
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
- 是
入选标准
- •For all participants:
- •Males and females ≥ 18 years of age
- •Individuals able and willing to provide written informed consent
- •Individuals able and willing to comply with the study protocol
- •For participants with asthma:
- •Individuals with physician confirmed asthma (12% bronchodilator reversibility or PC20 methacholine less than 8mg/ml)
- •Individuals treated with inhaled corticosteroids, oral corticosteroids and/or anti-T2 biologics
- •For participants who recently recovered from covid-19:
- •Individuals previously diagnosed with covid-19 confirmed by FLOQswab test
- •Individuals who recently (≤4-weeks) recovered from covid-19
排除标准
- •For all participants:
- •Males and females < 18 years of age
- •Individuals who are unable to read and/or understand English
- •Individuals who are pregnant or breastfeeding
- •Individuals who currently smoke or are an ex-smoker with ≥10 pack-year smoking history
- •Individuals who in the opinion of the investigator, are mentally or legally incapacitated, preventing informed consent from being obtained
- •Individuals who are unable to complete one or more study manoeuvres
- •For participants with no history of lung disease:
- •Individuals with a history of respiratory infection or disease
- •For participants who have not been diagnosed with covid-19:
- •Individuals who have previously had covid-19 confirmed by FLOQswab test
结局指标
主要结局
Short-term difference in perfusion defect percent assessed by perfusion SPECT-CT - healthy
时间窗: ≤4-weeks post COVID-19 recovery (Visit 1)
The short-term difference in lung perfusion between healthyCOVID-19+ and healthyCOVID-19- participants
Short-term difference in ventilation defect percent assessed by ventilation SPECT-CT - healthy
时间窗: ≤4-weeks post COVID-19 recovery (Visit 1)
The short-term difference in lung ventilation between healthyCOVID-19+ and healthyCOVID-19- participants
Short-term difference in lung ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - healthy
时间窗: ≤4-weeks post COVID-19 recovery (Visit 1)
The short-term difference in lung ventilation/perfusion mismatch between healthyCOVID-19+ and healthyCOVID-19- participants
Long-term difference in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - asthmatic
时间窗: 6-months post COVID-19 recovery (Visit 2)
The long-term difference in lung ventilation/perfusion mismatch between asthmaticCOVID-19+ and asthmaticCOVID-19- participants
Long-term difference in perfusion defect percent assessed by perfusion SPECT-CT - healthy
时间窗: 6-months post COVID-19 recovery (Visit 2)
The long-term difference in lung perfusion between healthyCOVID-19+ and healthyCOVID-19- participants
Short-term difference in ventilation defect percent assessed by ventilation SPECT-CT - asthmatic
时间窗: ≤4-weeks post COVID-19 recovery (Visit 1)
The short-term difference in lung ventilation between asthmaticCOVID-19+ and asthmaticCOVID-19- participants
Long-term difference in ventilation defect percent assessed by ventilation SPECT-CT - asthmatic
时间窗: 6-months post COVID-19 recovery (Visit 2)
The long-term difference in lung ventilation between asthmaticCOVID-19+ and asthmaticCOVID-19- participants
Longitudinal change in perfusion defect percent assessed by perfusion SPECT-CT - healthy
时间窗: 6-months post COVID-19 recovery (Visit 2)
Difference in the 6-month change in lung perfusion between healthyCOVID-19+ and healthyCOVID-19- participants
Long-term difference in perfusion defect percent assessed by perfusion SPECT-CT - asthmatic
时间窗: 6-months post COVID-19 recovery (Visit 2)
The long-term difference in lung perfusion between asthmaticCOVID-19+ and asthmaticCOVID-19- participants
Longitudinal change in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - healthy
时间窗: 6-months post COVID-19 recovery (Visit 2)
Difference in the 6-month change in lung ventilation/perfusion mismatch between healthyCOVID-19+ and healthyCOVID-19- participants
Longitudinal change in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - asthmatic
时间窗: 6-months post COVID-19 recovery (Visit 2)
Difference in the 6-month change in lung ventilation/perfusion mismatch between asthmaticCOVID-19+ and asthmaticCOVID-19- participants.
Longitudinal change in ventilation defect percent assessed by ventilation SPECT-CT - healthy
时间窗: 6-months post COVID-19 recovery (Visit 2)
Difference in the 6-month change in lung ventilation between healthyCOVID-19+ and healthyCOVID-19- participants
Long-term difference in ventilation defect percent assessed by ventilation SPECT-CT - healthy
时间窗: 6-months post COVID-19 recovery (Visit 2)
The long-term difference in lung ventilation between healthyCOVID-19+ and healthyCOVID-19- participants
Long-term difference in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - healthy
时间窗: 6-months post COVID-19 recovery (Visit 2)
The long-term difference in lung ventilation/perfusion mismatch between healthyCOVID-19+ and healthyCOVID-19- participants
Short-term difference in perfusion defect percent assessed by perfusion SPECT-CT - asthmatic
时间窗: ≤4-weeks post COVID-19 recovery (Visit 1)
The short-term difference in lung perfusion between asthmaticCOVID-19+ and asthmaticCOVID-19- participants
Short-term difference in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - asthmatic
时间窗: ≤4-weeks post COVID-19 recovery (Visit 1)
The short-term difference in lung ventilation/perfusion mismatch between asthmaticCOVID-19+ and asthmaticCOVID-19- participants
Longitudinal change in ventilation defect percent assessed by ventilation SPECT-CT - asthmatic
时间窗: 6-months post COVID-19 recovery (Visit 2)
Difference in the 6-month change in lung ventilation between asthmaticCOVID-19+ and asthmaticCOVID-19- participants.
Longitudinal change in perfusion defect percent assessed by perfusion SPECT-CT - asthmatic
时间窗: 6-months post COVID-19 recovery (Visit 2)
Difference in the 6-month change in lung perfusion between asthmaticCOVID-19+ and asthmaticCOVID-19- participants.
次要结局
- Correlation of lung ventilation with six-minute walk distance (6MWD) 6-months post COVID-19 recovery(6-months post COVID-19 recovery (Visit 2))
- Correlation of lung ventilation with the forced expiratory volume in one second (FEV1) 6-months post COVID-19 recovery(6-months post COVID-19 recovery (Visit 2))
- Correlation of lung ventilation with six-minute walk distance (6MWD) ≤4-weeks post COVID-19 recovery(≤4-weeks post COVID-19 recovery (Visit 1))
- Correlation of lung ventilation with the diffusing capacity of the lung for carbon monoxide (DLCO) 6-months post COVID-19 recovery(6-months post COVID-19 recovery (Visit 2))
- Correlation of lung ventilation with the St. George's Respiratory Questionnaire (SGRQ) score ≤4-weeks post COVID-19 recovery(≤4-weeks post COVID-19 recovery (Visit 1))
- Correlation of lung ventilation with the forced expiratory volume in one second (FEV1) ≤4-weeks post COVID-19 recovery(≤4-weeks post COVID-19 recovery (Visit 1))
- Correlation of lung ventilation with the St. George's Respiratory Questionnaire (SGRQ) score 6-months post COVID-19 recovery(6-months post COVID-19 recovery (Visit 2))
- Correlation of lung ventilation with the diffusing capacity of the lung for carbon monoxide (DLCO) ≤4-weeks post COVID-19 recovery(≤4-weeks post COVID-19 recovery (Visit 1))