Assessing the Effects of Coronavirus Disease (COVID-19) on Multiple Organ Systems and Impact on Quality of Life, Functional Capacity and Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Prevalence of damage (quantitative measures of injury) on lung, heart, liver, kidneys and brain MRI.
研究概览
简要总结
The C-MORE study is prospective observational holistic longitudinal study which will characterise the prevalence of multi-organ injury among COVID-19 survivors post hospital discharge and assess its effects on quality of life, exercise tolerance and mental health.
详细描述
Since the outbreak of Coronavirus disease (COVID-19), hundreds of thousands of lives have been lost and millions significantly affected. Although primarily a respiratory viral illness, emerging data suggests that multiorgan involvement is common in those with moderate-severe infections. Whether or not persistent multiorgan damage will be seen in COVID-19 survivors is unknown.
C-MORE is an observational study that aims to investigate the long-term effects of COVID-19 on the lungs, heart, brain, liver and kidneys using advanced state-of-the art magnetic resonance imaging (MRI) technology. The study will assess 616 patients with laboratory-confirmed COVID-19 from leading UK centres and undertake multi-organ magnetic resonance imaging at 3, 6, and 12 months following the onset of COVID-19 symptoms. In addition, assessments of breathing, exercise capacity, cognition and mental health will be carried out.
The study will describe the prevalence of persistent multi-organ injury in COVID-19 patients and assess how this relates to comorbid conditions, severity of acute respiratory illness, immunological response, genetic factors, quality of life and mental health.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 18 years or above.
- •Diagnosis of COVID-19 infection confirmed by detection of viral nucleic acid on reverse-transcription Polymerase Chain Reaction (RT-PCR).
- •Infection should be of moderate to severe intensity (i.e, patients with clinical signs of pneumonia such as respiratory rate > 30 breaths/min; or severe respiratory distress; or SpO2 < 90% (on room air) and admission for >48 hours.
- •Controls: Participants with no serological evidence of previous infection, or active/previous symptoms suggestive of COVID-19, and who may or may not have comorbidities.
排除标准
- •Contraindication to MRI e.g. pregnancy, pacemaker, ferromagnetic implant, shrapnel injury, severe claustrophobia, inability to lie flat.
- •Any other significant disease or disorder which, in the opinion of the investigator, might influence the participant's ability to participate in the study.
- •Any signs of active COVID-19 infection on day of visit.
- •Significantly impaired renal function (eGFR<30 ml/min)
结局指标
主要结局
Prevalence of damage (quantitative measures of injury) on lung, heart, liver, kidneys and brain MRI.
时间窗: 6 months
Characterise and compare the prevalence and extent of lung, heart, liver, kidney, brain injury on magnetic resonance imaging (MRI) in patients with moderate to severe COVID-19 disease with matched uninfected controls.
次要结局
- Prevalence of abnormal lung function test (any of the following: Forced expiratory volume in 1 second (FEV1)< 80% of predicted FEV1, or forced vital capacity (FVC)<80% predicted, ratio of FEV1/FVC >0.7 or diffusion lung capacity (<80% predicted))(3, 6,12 months)
- Severity of depression on PHQ-9 (Score)(3, 6,12 months)
- Association between the extent of multi-organ injury (continuous variable) and markers of inflammation (white cell count).(3,6,12 months)
- VO2 max on cardiopulmonary exercise testing(3, 6,12 months)
- Prevalence of impaired cognitive function on Montreal Cognitive assessment (MoCA<26)(3, 6,12 months)
- Severity of anxiety on GAD-7 (Score)(3, 6,12 months)
- Prevalence of damage (quantitative measures of injury) on lungs, heart, liver, kidneys and brain on MRI.(3 and 12 months)
- Prevalence of acute/chronic cardiac, renal and liver injury on blood tests.(3, 6,12 months)
- Quality of life - Short form-36 SF-36 score(3, 6,12 months)
- 6-minute walk distance(3, 6,12 months)
- Correlation between the extent of symptoms (dyspnoea-12 score and fatigue score) and multi-organ injury.(3,6,12months.)