Capturing MultiORgan Effects of COVID-19

NCT04510025 | Recruiting DMC

• 1 other identifier: 282608
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Infection; Multi-Organ Disorder

Keywords

Coronavirus disease; MRI; Multi-organ injury; Quality of Life; Mental Health

Outcome Measures

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.

  6 months

Secondary Outcomes (11)

• Prevalence of damage (quantitative measures of injury) on lungs, heart, liver, kidneys and brain on MRI.

  3 and 12 months

• Prevalence of acute/chronic cardiac, renal and liver injury on blood tests.

  3, 6,12 months

• VO2 max on cardiopulmonary exercise testing

  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))

  3, 6,12 months

• Quality of life - Short form-36 SF-36 score

  3, 6,12 months

Study Arms (2)

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

COVID-19

Hospitalised patients with moderate to severe infection (admitted for at least 2 days in hospital).

Diagnostic Test: Magnetic Resonance Imaging

Interventions

Magnetic Resonance Imaging DIAGNOSTIC_TEST

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.

Also known as: Cardiopulmonary exercise test, Spirometry, 6 minute walk test, Questionnaires (mental health, cognitive assessment and quality of life), Blood test, Transthoracic echocardiography (Sub-study), CT lungs (Sub-study)

COVID-19; Non-COVID

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

University of Oxford

Oxford, OX3 9DU, United Kingdom

RECRUITING

Related Publications (2)

• 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.

  PMID: 40050066 DERIVED

• C-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.

  PMID: 37748493 DERIVED

Related Links

• Interim results

Biospecimen

Retention: SAMPLES WITH DNA

10 ml of blood stored

MeSH Terms

Conditions

Coronavirus Infections; Psychological Well-Being

Interventions

Magnetic Resonance Imaging; Exercise Test; Spirometry; Walk Test; Hematologic Tests; Echocardiography

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques; Clinical Laboratory Techniques; Cardiac Imaging Techniques; Ultrasonography

Central Study Contacts

Betty Raman, MBBS, DPhil, FRACP

CONTACT

01865234580; betty.raman@cardiov.ox.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: August 12, 2020
• Study Start: May 13, 2020
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 7, 2025

Record last verified: 2025-01

Locations

GB (1)