Capturing MultiORgan Effects of COVID-19
- Conditions
- Multi-Organ DisorderCoronavirus Infection
- Interventions
- Diagnostic Test: Magnetic Resonance Imaging
- Registration Number
- NCT04510025
- Lead Sponsor
- University of Oxford
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 750
- 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.
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non-COVID Magnetic Resonance Imaging We will enrol age, gender, BMI and co-morbidity matched non-COVID control subjects ( no serological evidence of previous infection or active symptoms). COVID-19 Magnetic Resonance Imaging Hospitalised patients with moderate to severe infection (admitted for at least 2 days in hospital).
- Primary Outcome Measures
Name Time Method Prevalence of damage (quantitative measures of injury) on lung, heart, liver, kidneys and brain MRI. 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.
- Secondary Outcome Measures
Name Time Method Prevalence of damage (quantitative measures of injury) on lungs, heart, liver, kidneys and brain on MRI. 3 and 12 months Characterise and compare the prevalence and extent of lung, heart, liver and kidney, brain injury on magnetic resonance imaging (MRI) in patients with moderate to severe COVID-19 disease with matched uninfected controls.
Prevalence of acute/chronic cardiac, renal and liver injury on blood tests. 3, 6,12 months Characterise and compare the prevalence of cardiac, renal and liver injury on blood test in COVID-19 survivors and controls.
Quality of life - Short form-36 SF-36 score 3, 6,12 months For each of the eight domains that the SF36 measures an aggregate percentage score is produced. The percentage scores range from 0% (lowest or worst possible level of functioning) to 100% (highest or best possible level of functioning).
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 Characterise and compare the prevalence of lung function test abnormalities among survivors and controls.
Severity of depression on PHQ-9 (Score) 3, 6,12 months Compare prevalence and severity of depression among COVID-19 survivors and controls. PHQ-9 total score for the nine items ranges from 0 to 27. Scores of 5, 10, 15, and 20 represent outpoints for mild, moderate, moderately severe and severe depression, respectively.
Association between the extent of multi-organ injury (continuous variable) and markers of inflammation (white cell count). 3,6,12 months To assess the association of multi organ damage on MRI and inflammatory response.
VO2 max on cardiopulmonary exercise testing 3, 6,12 months Characterise and compare VO2 max on cardiopulmonary exercise testing in COVID-19 survivors and controls.
Prevalence of impaired cognitive function on Montreal Cognitive assessment (MoCA<26) 3, 6,12 months Described and compare the prevalence of impaired cognition (MoCA) between COVID-19 survivors and controls. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal.
Severity of anxiety on GAD-7 (Score) 3, 6,12 months Compare prevalence and severity of anxiety between COVID-19 survivors and controls.
6-minute walk distance 3, 6,12 months Compare 6-minute walk distance between COVID-19 survivors and controls.
Correlation between the extent of symptoms (dyspnoea-12 score and fatigue score) and multi-organ injury. 3,6,12months. To assess the association of ongoing symptomatology and multi-organ injury/inflammation.
Trial Locations
- Locations (1)
University of Oxford
🇬🇧Oxford, United Kingdom