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NCT Number: NCT04510025

Capturing MultiORgan Effects of COVID-19

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.

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Key information

Conditions

Coronavirus Infection Behavior Coronaviridae Infections Coronavirus Infections Infections Multi-Organ Disorder Nidovirales Infections Personal Satisfaction Psychological Well-Being RNA Virus Infections Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Oxford

Oxford, OX3 9DU, United Kingdom

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: 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)

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 3 and 12 months

    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.

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

    Time frame: 3, 6,12 months

    Characterise and compare the prevalence of cardiac, renal and liver injury on blood test in COVID-19 survivors and controls.

  3. VO2 max on cardiopulmonary exercise testing

    Time frame: 3, 6,12 months

    Characterise and compare VO2 max on cardiopulmonary exercise testing in COVID-19 survivors and controls.

  4. 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

    Characterise and compare the prevalence of lung function test abnormalities among survivors and controls.

  5. Quality of life - Short form-36 SF-36 score

    Time frame: 3, 6,12 months

    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).

  6. Prevalence of impaired cognitive function on Montreal Cognitive assessment (MoCA<26)

    Time frame: 3, 6,12 months

    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.

  7. 6-minute walk distance

    Time frame: 3, 6,12 months

    Compare 6-minute walk distance between COVID-19 survivors and controls.

  8. Severity of anxiety on GAD-7 (Score)

    Time frame: 3, 6,12 months

    Compare prevalence and severity of anxiety between COVID-19 survivors and controls.

  9. Severity of depression on PHQ-9 (Score)

    Time frame: 3, 6,12 months

    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.

  10. Association between the extent of multi-organ injury (continuous variable) and markers of inflammation (white cell count).

    Time frame: 3,6,12 months

    To assess the association of multi organ damage on MRI and inflammatory response.

  11. Correlation between the extent of symptoms (dyspnoea-12 score and fatigue score) and multi-organ injury.

    Time frame: 3,6,12months.

    To assess the association of ongoing symptomatology and multi-organ injury/inflammation.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

Assessing the Effects of Coronavirus Disease (COVID-19) on Multiple Organ Systems and Impact on Quality of Life, Functional Capacity and Mental Health

Acronym: C-MORE

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2020
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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