Coronavirus InfectionC-MORENCT04510025
Capturing MultiORgan Effects of COVID-19
An observational study of Coronavirus Infection and Multi-Organ Disorder, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infection, Multi-Organ Disorder
- What is being tested?
- Magnetic Resonance Imaging
- How many people
- 750 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 May 2020to 1 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Oxford
Oxford, OX3 9DU
Betty Raman, MBBS, FRACP, DPhil, 0186534580 ext. +44, betty.raman@cardiov.ox.ac.uk
Mark Cassar, MBBS, 0186534580 ext. +44
About this study
Official title: Assessing the Effects of Coronavirus Disease (COVID-19) on Multiple Organ Systems and Impact on Quality of Life, Functional Capacity and Mental Health
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.
Read the 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.
- Conditions
- Coronavirus Infection, Multi-Organ Disorder
- Being tested
- Magnetic Resonance Imaging
- Keywords
- Coronavirus disease, MRI, Multi-organ injury, Quality of Life, Mental Health
- Medical subject headings
- Coronavirus Infections, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDiagnostic test
Also called Cardiopulmonary exercise test, Spirometry, 6 minute walk test, Questionnaires (mental health, cognitive assessment and quality of life)
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-COVID | We will enrol age, gender, BMI and co-morbidity matched non-COVID control subjects (no serological evidence of previous infection, or active/previous symptoms suggestive of COVID-19). A minimum of 200 controls (as part of the COSMIC study) will be recruited. Receives: Diagnostic Test: Magnetic Resonance Imaging | |
| COVID-19 | Hospitalised patients with moderate to severe infection (admitted for at least 2 days in hospital). Receives: Diagnostic Test: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (11)
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.
Measured: 3 and 12 months
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.
Measured: 3, 6,12 months
VO2 max on cardiopulmonary exercise testing
Characterise and compare VO2 max on cardiopulmonary exercise testing in COVID-19 survivors and controls.
Measured: 3, 6,12 months
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.
Measured: 3, 6,12 months
Quality of life - Short form-36 SF-36 score
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).
Measured: 3, 6,12 months
Prevalence of impaired cognitive function on Montreal Cognitive assessment (MoCA<26)
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.
Measured: 3, 6,12 months
6-minute walk distance
Compare 6-minute walk distance between COVID-19 survivors and controls.
Measured: 3, 6,12 months
Severity of anxiety on GAD-7 (Score)
Compare prevalence and severity of anxiety between COVID-19 survivors and controls.
Measured: 3, 6,12 months
Severity of depression on PHQ-9 (Score)
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.
Measured: 3, 6,12 months
Association between the extent of multi-organ injury (continuous variable) and markers of inflammation (white cell count).
To assess the association of multi organ damage on MRI and inflammatory response.
Measured: 3,6,12 months
Correlation between the extent of symptoms (dyspnoea-12 score and fatigue score) and multi-organ injury.
To assess the association of ongoing symptomatology and multi-organ injury/inflammation.
Measured: 3,6,12months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start13 May 2020
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510025
- Sponsor's protocol ID
- 282608
- Acronym
- C-MORE
- Status last verified
- Jan 2025
- First submitted
- 14 Jul 2020
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shergill S, Elshibly M, Hothi SS, Parke KS, England RJ, Wormleighton JV, Hudson GJ, Tunnicliffe EM, Wild J, Smith SM, Francis S, Toshner M, Sattar N, Khunti K, Brightling CE, Antoniades C, Berry C, Greenwood JP, Moss A, Neubauer S, McCann GP, Raman B, Arnold JR. Assessing the impact of COmorbidities and Sociodemographic factors on Multiorgan Injury following COVID-19: rationale and protocol design of COSMIC, a UK multicentre observational study of COVID-negative controls. BMJ Open. 2025 Mar 6;15(3):e089508. doi: 10.1136/bmjopen-2024-089508.
PubMed 40050066C-MORE/PHOSP-COVID Collaborative Group. Multiorgan MRI findings after hospitalisation with COVID-19 in the UK (C-MORE): a prospective, multicentre, observational cohort study. Lancet Respir Med. 2023 Nov;11(11):1003-1019. doi: 10.1016/S2213-2600(23)00262-X. Epub 2023 Sep 22.
PubMed 37748493
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effects of Coronavirus Disease (COVID-19) on Multiple Organ Systems and Impact on Quality of Life, Functional Capacity and Mental Health
- ClinicalTrials.gov ID
- NCT04510025
- Acronym / sponsor ID
- C-MORE / 282608
- Conditions
- Coronavirus Infection, Multi-Organ Disorder
- Keywords
- Coronavirus disease, MRI, Multi-organ injury, Quality of Life, Mental Health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 13 May 2020 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-COVID | – | Diagnostic Test: Magnetic Resonance ImagingWe will enrol age, gender, BMI and co-morbidity matched non-COVID control subjects (no serological evidence of previous infection, or active/previous symptoms suggestive of COVID-19). A minimum of 200 controls (as part of the COSMIC study) will be recruited. |
| COVID-19 | – | Diagnostic Test: Magnetic Resonance ImagingHospitalised patients with moderate to severe infection (admitted for at least 2 days in hospital). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingAlso: Cardiopulmonary exercise test, Spirometry, 6 minute walk test, Questionnaires (mental health, cognitive assessment and quality of life)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. | Diagnostic test | COVID-19, Non-COVID |
Primary outcome
Prevalence of damage (quantitative measures of injury) on lung, heart, liver, kidneys and brain MRI.
Time frame: 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.
11 secondary outcomes
Prevalence of damage (quantitative measures of injury) on lungs, heart, liver, kidneys and brain on MRI.
Time frame: 3 and 12 months
Prevalence of acute/chronic cardiac, renal and liver injury on blood tests.
Time frame: 3, 6,12 months
VO2 max on cardiopulmonary exercise testing
Time frame: 3, 6,12 months
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
Quality of life - Short form-36 SF-36 score
Time frame: 3, 6,12 months
Prevalence of impaired cognitive function on Montreal Cognitive assessment (MoCA<26)
Time frame: 3, 6,12 months
6-minute walk distance
Time frame: 3, 6,12 months
Severity of anxiety on GAD-7 (Score)
Time frame: 3, 6,12 months
Severity of depression on PHQ-9 (Score)
Time frame: 3, 6,12 months
Association between the extent of multi-organ injury (continuous variable) and markers of inflammation (white cell count).
Time frame: 3,6,12 months
Correlation between the extent of symptoms (dyspnoea-12 score and fatigue score) and multi-organ injury.
Time frame: 3,6,12months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Derived from this study: PubMed 40050066Shergill S, Elshibly M, Hothi SS, Parke KS, England RJ, Wormleighton JV, Hudson GJ, Tunnicliffe EM, Wild J, Smith SM, Francis S, Toshner M, Sattar N, Khunti K, Brightling CE, Antoniades C, Berry C, Greenwood JP, Moss A, Neubauer S, McCann GP, Raman B, Arnold JR. Assessing the impact of COmorbidities and Sociodemographic factors on Multiorgan Injury following COVID-19: rationale and protocol design of COSMIC, a UK multicentre observational study of COVID-negative controls. BMJ Open. 2025 Mar 6;15(3):e089508. doi: 10.1136/bmjopen-2024-089508.
- Derived from this study: PubMed 37748493C-MORE/PHOSP-COVID Collaborative Group. Multiorgan MRI findings after hospitalisation with COVID-19 in the UK (C-MORE): a prospective, multicentre, observational cohort study. Lancet Respir Med. 2023 Nov;11(11):1003-1019. doi: 10.1016/S2213-2600(23)00262-X. Epub 2023 Sep 22.
- Interim resultsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infection and Multi-Organ Disorder, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Betty Raman, MBBS, DPhil, FRACP (01865234580 ext. +44, betty.raman@cardiov.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of damage (quantitative measures of injury) on lung, heart, liver, kidneys and brain MRI. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04510025, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.