- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04510025
Capturing MultiORgan Effects of COVID-19 (C-MORE)
Assessing the Effects of Coronavirus Disease (COVID-19) on Multiple Organ Systems and Impact on Quality of Life, Functional Capacity and Mental Health
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Betty Raman, MBBS, DPhil, FRACP
- Phone Number: +44 01865234580
- Email: betty.raman@cardiov.ox.ac.uk
Study Locations
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Oxford, United Kingdom, OX3 9DU
- Recruiting
- University of Oxford
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Contact:
- Betty Raman, MBBS, FRACP, DPhil
- Phone Number: +44 0186534580
- Email: betty.raman@cardiov.ox.ac.uk
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Contact:
- Mark Cassar, MBBS
- Phone Number: +44 0186534580
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Principal Investigator:
- Stefan Neubauer, MD, FMedSCi
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Principal Investigator:
- Betty Raman, MBBS, DPhil, FRACP
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- 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)
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Non-COVID
We will enrol age, gender, BMI and co-morbidity matched non-COVID control subjects ( no serological evidence of previous infection or active symptoms).
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We will undertake multi-organ MRI to assess the health of vital organs including the brain, heart, lung, kidneys and liver.
We will additionally examine the burden of ongoing respiratory limitations, mental health problems and quality of life in survivors of COVID-19 at 3, 6 and 12 months.
Other Names:
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COVID-19
Hospitalised patients with moderate to severe infection (admitted for at least 2 days in hospital).
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We will undertake multi-organ MRI to assess the health of vital organs including the brain, heart, lung, kidneys and liver.
We will additionally examine the burden of ongoing respiratory limitations, mental health problems and quality of life in survivors of COVID-19 at 3, 6 and 12 months.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of damage (quantitative measures of injury) on lung, heart, liver, kidneys and brain MRI.
Time Frame: 6 months
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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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of damage (quantitative measures of injury) on lungs, heart, liver, kidneys and brain on MRI.
Time Frame: 3 and 12 months
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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.
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3 and 12 months
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Prevalence of acute/chronic cardiac, renal and liver injury on blood tests.
Time Frame: 3, 6,12 months
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Characterise and compare the prevalence of cardiac, renal and liver injury on blood test in COVID-19 survivors and controls.
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3, 6,12 months
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VO2 max on cardiopulmonary exercise testing
Time Frame: 3, 6,12 months
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Characterise and compare VO2 max on cardiopulmonary exercise testing in COVID-19 survivors and controls.
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3, 6,12 months
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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))
Time Frame: 3, 6,12 months
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Characterise and compare the prevalence of lung function test abnormalities among survivors and controls.
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3, 6,12 months
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Quality of life - Short form-36 SF-36 score
Time Frame: 3, 6,12 months
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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).
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3, 6,12 months
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Prevalence of impaired cognitive function on Montreal Cognitive assessment (MoCA<26)
Time Frame: 3, 6,12 months
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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.
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3, 6,12 months
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6-minute walk distance
Time Frame: 3, 6,12 months
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Compare 6-minute walk distance between COVID-19 survivors and controls.
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3, 6,12 months
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Severity of anxiety on GAD-7 (Score)
Time Frame: 3, 6,12 months
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Compare prevalence and severity of anxiety between COVID-19 survivors and controls.
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3, 6,12 months
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Severity of depression on PHQ-9 (Score)
Time Frame: 3, 6,12 months
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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.
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3, 6,12 months
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Association between the extent of multi-organ injury (continuous variable) and markers of inflammation (white cell count).
Time Frame: 3,6,12 months
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To assess the association of multi organ damage on MRI and inflammatory response.
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3,6,12 months
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Correlation between the extent of symptoms (dyspnoea-12 score and fatigue score) and multi-organ injury.
Time Frame: 3,6,12months.
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To assess the association of ongoing symptomatology and multi-organ injury/inflammation.
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3,6,12months.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 282608
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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