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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronavirus Infection; Multi-Organ Disorder
• Intervention / Treatment: Diagnostic test: Magnetic Resonance Imaging

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: Observational
• Enrollment (Estimated): 750

Contacts and Locations

• Study Contact: Name: Betty Raman, MBBS, DPhil, FRACP; Phone Number: +44 01865234580; Email: betty.raman@cardiov.ox.ac.uk

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX3 9DU
    • Recruiting
    • University of Oxford
    • Contact: Betty Raman, MBBS, FRACP, DPhil; Phone Number: +44 0186534580; Email: betty.raman@cardiov.ox.ac.uk
    • Contact: Mark Cassar, MBBS; Phone Number: +44 0186534580
    • Principal Investigator: Stefan Neubauer, MD, FMedSCi
    • Principal Investigator: Betty Raman, MBBS, DPhil, FRACP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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.

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.
• 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.

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19; Hospitalised patients with moderate to severe infection (admitted for at least 2 days in hospital).	Diagnostic test: Magnetic Resonance Imaging; 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: Spirometry; Blood test; Cardiopulmonary exercise test; 6 minute walk test; Questionnaires (mental health, cognitive assessment and quality of life); Transthoracic echocardiography (Sub-study); CT lungs (Sub-study)
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.	Diagnostic test: Magnetic Resonance Imaging; 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: Spirometry; Blood test; Cardiopulmonary exercise test; 6 minute walk test; Questionnaires (mental health, cognitive assessment and quality of life); Transthoracic echocardiography (Sub-study); CT lungs (Sub-study)

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.	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.	6 months

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.	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.	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.	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.	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.	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).	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.	3, 6,12 months
6-minute walk distance	Compare 6-minute walk distance between COVID-19 survivors and controls.	3, 6,12 months
Severity of anxiety on GAD-7 (Score)	Compare prevalence and severity of anxiety between COVID-19 survivors and controls.	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.	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.	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.	3,6,12months.

Collaborators and Investigators

• Sponsor: University of Oxford

Publications and helpful links

Helpful Links

• Interim results

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2020
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (Actual): August 12, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: MRI; Mental Health; Quality of Life; Coronavirus disease; Multi-organ injury
• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; Coronavirus Infections
• Other Study ID Numbers: 282608

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No