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Capturing MultiORgan Effects of COVID-19 (C-MORE)

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ClinicalTrials.gov Identifier: NCT04510025
Recruitment Status : Recruiting
First Posted : August 12, 2020
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
University of Oxford

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.

Condition or disease Intervention/treatment
Coronavirus Infection Multi-Organ Disorder 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.

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Study Type : Observational
Estimated Enrollment : 616 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : May 13, 2020
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2023


Group/Cohort Intervention/treatment
Non-COVID
We will enrol age, gender, BMI and co-morbidity matched non-COVID control subjects ( no serological evidence of previous infection or active symptoms).
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:
  • 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
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:
  • 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 Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
10 ml of blood stored


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  • 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)
Criteria

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.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510025


Contacts
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Contact: Betty Raman, MBBS, DPhil, FRACP 01865234580 ext +44 betty.raman@cardiov.ox.ac.uk

Locations
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United Kingdom
University of Oxford Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Betty Raman, MBBS, FRACP, DPhil    0186534580 ext +44    betty.raman@cardiov.ox.ac.uk   
Contact: Mark Cassar, MBBS    0186534580 ext +44      
Principal Investigator: Stefan Neubauer, MD, FMedSCi         
Principal Investigator: Betty Raman, MBBS, DPhil, FRACP         
Sponsors and Collaborators
University of Oxford
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT04510025    
Other Study ID Numbers: 282608
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
Coronavirus disease
MRI
Multi-organ injury
Quality of Life
Mental Health
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases