Capturing MultiORgan Effects of COVID-19
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity of Oxford
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial population
A minimum of 500 participants who have recently been hospitalised with moderate-severe COVID-19 infection. A minimum of 200 individuals with no serological evidence of previous infection , or active/previous symptoms suggestive of COVID-19 will serve as controls.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Magnetic Resonance Imaging
Diagnostic testWe 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.
Treatment groups
750 Participants
are divided into 2 treatment groupsGroup A: Non-COVID1 intervention
Group B: COVID-191 intervention
Trial outcomes
Primary outcomes
1
Prevalence of damage (quantitative measures of injury) on lung, heart, liver, kidneys and brain MRI.
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.
Time frame
6 monthsSecondary outcomes
1
Prevalence of damage (quantitative measures of injury) on lungs, heart, liver, kidneys and brain on MRI.
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.
Time frame
3 and 12 months2
Prevalence of acute/chronic cardiac, renal and liver injury on blood tests.
Characterise and compare the prevalence of cardiac, renal and liver injury on blood test in COVID-19 survivors and controls.
Time frame
3, 6,12 months3
VO2 max on cardiopulmonary exercise testing
Characterise and compare VO2 max on cardiopulmonary exercise testing in COVID-19 survivors and controls.
Time frame
3, 6,12 months4
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))
Characterise and compare the prevalence of lung function test abnormalities among survivors and controls.
Time frame
3, 6,12 monthsSponsors and contacts
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Source ClinicalTrials.gov