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

August 14, 2020 updated by: University of Oxford

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

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 (Anticipated)

616

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Oxford, United Kingdom, OX3 9DU
        • Recruiting
        • University of Oxford
        • Contact:
        • Contact:
          • Mark Cassar, MBBS
          • Phone Number: +44 0186534580
        • Principal Investigator:
          • Stefan Neubauer, MD, FMedSCi
        • Principal Investigator:
          • Betty Raman, MBBS, DPhil, FRACP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

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.

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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).
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)
COVID-19
Hospitalised patients with moderate to severe infection (admitted for at least 2 days in hospital).
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.
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.
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.
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.
3 and 12 months
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, 6,12 months
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.
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
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
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).
3, 6,12 months
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.
3, 6,12 months
6-minute walk distance
Time Frame: 3, 6,12 months
Compare 6-minute walk distance between COVID-19 survivors and controls.
3, 6,12 months
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.
3, 6,12 months
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.
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
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.
Time Frame: 3,6,12months.
To assess the association of ongoing symptomatology and multi-organ injury/inflammation.
3,6,12months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2020

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

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)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 14, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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