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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Prevalence of damage (quantitative measures of injury) on lung, heart, liver, kidneys and brain MRI. [Time frame: 6 months]

Secondary outcome measures (11)

• Prevalence of damage (quantitative measures of injury) on lungs, heart, liver, kidneys and brain on MRI. [Time frame: 3 and 12 months]
• Prevalence of acute/chronic cardiac, renal and liver injury on blood tests. [Time frame: 3, 6,12 months]
• VO2 max on cardiopulmonary exercise testing [Time frame: 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]
• Quality of life - Short form-36 SF-36 score [Time frame: 3, 6,12 months]
• Prevalence of impaired cognitive function on Montreal Cognitive assessment (MoCA<26) [Time frame: 3, 6,12 months]
• 6-minute walk distance [Time frame: 3, 6,12 months]
• Severity of anxiety on GAD-7 (Score) [Time frame: 3, 6,12 months]
• Severity of depression on PHQ-9 (Score) [Time frame: 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]
• Correlation between the extent of symptoms (dyspnoea-12 score and fatigue score) and multi-organ injury. [Time frame: 3,6,12months.]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

United Kingdom · 1 center

• University of Oxford — Oxford

Publications

• Shergill S, Elshibly M, Hothi SS, Parke KS, England RJ, Wormleighton JV, Hudson GJ, Tunnicliffe EM, Wild J, Smith SM, Francis S, Toshner M, Sattar N, Khunti K, Brightling CE, Antoniades C, Berry C, Greenwood JP, Moss A, Neubauer S, McCann GP, Raman B, Arnold JR. Assessing the impact of COmorbidities and Sociodemographic factors on Multiorgan Injury following COVID-19: rationale and protocol design PMID 40050066
• C-MORE/PHOSP-COVID Collaborative Group. Multiorgan MRI findings after hospitalisation with COVID-19 in the UK (C-MORE): a prospective, multicentre, observational cohort study. Lancet Respir Med. 2023 Nov;11(11):1003-1019. doi: 10.1016/S2213-2600(23)00262-X. Epub 2023 Sep 22. PMID 37748493

Identifiers

NCT: NCT04510025 · 282608

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗