Clinical trial NCT04510025: Capturing MultiORgan Effects of COVID-19
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronavirus Infection
Multi-Organ Disorder
Keywords: Coronavirus disease
MRI
Multi-organ injury
Quality of Life
Mental Health
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.
* 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)

Primary outcomes:
measure: Prevalence of damage (quantitative measures of injury) on lung, heart, liver, kidneys and brain MRI.
timeFrame: 6 months
Secondary outcomes:
measure: Prevalence of damage (quantitative measures of injury) on lungs, heart, liver, kidneys and brain on MRI.
timeFrame: 3 and 12 months
measure: Prevalence of acute/chronic cardiac, renal and liver injury on blood tests.
timeFrame: 3, 6,12 months
measure: VO2 max on cardiopulmonary exercise testing
timeFrame: 3, 6,12 months
measure: 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))
timeFrame: 3, 6,12 months
measure: Quality of life - Short form-36 SF-36 score
timeFrame: 3, 6,12 months
measure: Prevalence of impaired cognitive function on Montreal Cognitive assessment (MoCA<26)
timeFrame: 3, 6,12 months
measure: 6-minute walk distance
timeFrame: 3, 6,12 months
measure: Severity of anxiety on GAD-7 (Score)
timeFrame: 3, 6,12 months
measure: Severity of depression on PHQ-9 (Score)
timeFrame: 3, 6,12 months
measure: Association between the extent of multi-organ injury (continuous variable) and markers of inflammation (white cell count).
timeFrame: 3,6,12 months
measure: Correlation between the extent of symptoms (dyspnoea-12 score and fatigue score) and multi-organ injury.
timeFrame: 3,6,12months.
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: University of Oxford
Study officials:
References: