Capturing MultiORgan Effects of COVID-19

Coronavirus Infection Clinical Trial

— C-MORE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04510025
• Other study ID #: 282608
• Status: Recruiting
• Start date: May 13, 2020
• Est. completion date: May 1, 2023

Study information

• Verified date: May 2020
• Source: University of Oxford
• Contact: Betty Raman, MBBS, DPhil, FRACP
• Phone: 01865234580
• Email: betty.raman[@]cardiov.ox.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 616
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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:

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Multi-Organ Disorder
• Severe Acute Respiratory Syndrome

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	University of Oxford	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	6-minute walk distance	Compare 6-minute walk distance between COVID-19 survivors and controls.	3, 6,12 months
Secondary	Severity of anxiety on GAD-7 (Score)	Compare prevalence and severity of anxiety between COVID-19 survivors and controls.	3, 6,12 months
Secondary	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
Secondary	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
Secondary	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.