Mapping Organ Health Following COVID-19 Disease Due to SARS-CoV-2 Infection

NCT04369807 | Completed

• 1 other identifier: 20/SC/0185
• Study Type: observational
• Target: 693
• Locations: 1 country
• Sites: 2

Brief Summary

A prospective, longitudinal, observational cohort study looking at patients following COVID-19 disease using multi-parametric magnetic resonance imaging (MRI) to assess the degree and prevalence of organ injury.

Conditions

COVID-19

Keywords

Metabolic Syndrome; Obesity; Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Characterise prevalence and severity of organ volume change and damage (heart, kidneys and liver)

  In patients recovering from COVID-19 disease: Characterise using summary statistics the prevalence and severity of organ volume change and damage to heart, kidneys and liver

  12 Months

Secondary Outcomes (7)

• Characterise prevalence and severity of organ volume change and damage (lung, pancreas and spleen)

  12 Months

• Change from Baseline in liver-specific biomarkers: volume, iron corrected T1(cT1), fat content and T2star

  6 Months

• Change from Baseline in organ-specific biomarkers characterising organ volume change in the heart and spleen along with organ volume and damage in the kidney, liver and pancreas assessed by volume, iron corrected T1 (cT1) and fat infiltration

  12 Months

• Change in patient reported outcome measured by the Dyspnea-12 questionnaire

  12 Months

• Change in patient reported outcome measured by the Saint George's Respiratory questionnaire (SGRQ)

  12 Months

Interventions

Outpatient MRI DIAGNOSTIC_TEST

Participation in the study includes up to 3 visits to a partnering imaging facility - this will include measurement of height and weight (to calculate BMI), blood pressure measurement, 3 sets of blood tests, 3 Questionnaires and 3 MRI tests. There will be no medical interventions as part of the study. All participants will receive standard-of-care by their healthcare provider/s. With the participant's consent, the participant's primary care physician will be made aware of their participation in the study. Furthermore, participants will be informed of any structural abnormalities found in the MRI scan (e.g. abnormal vessels, haemangioma, tumour, cyst, among others) and abnormal blood test results as these may have clinical implications.

Also known as: Outpatient blood tests for laboratory studies and genotyping, Outpatient measurements (height, weight, blood pressure), Online Questionnaires

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be recovered or recovering from COVID-19 disease, at least age 18 years and invited to partake in this study. Participants will previously have experienced symptomatic and confirmed COVID-19 disease and will be outpatients able to breath independently without oxygen. Participants will have been discharged back into the community with no respiratory symptoms for at least 7 days. Although subsequent negative testing for infectivity is ideal prior to study entry, participants will be considered non-infectious based on the absence of any fever or severe cough for at least 7 days, as per the advice of the UK Chief Medical Officer.

You may qualify if:

• Male or female 18 years of age and older willing and able to give informed consent to participate in the study
• Recent confirmed diagnosis of SARS-CoV-2 RNA via a polymerase chain reaction (PCR) assay (having been discharged 7 or more days from hospital).

You may not qualify if:

• Symptoms of active respiratory viral infection:
• high temperature (over 37.8C/100.04F)
• cough (consistent for over an hour; 3 or more episodes in 24 hours)
• The participant may not enter the study with any known contraindication to magnetic resonance imaging (including but not limited to pregnancy, a pacemaker or other metallic unfixed implanted device, metallic fragments, extensive tattoos, severe claustrophobia).
• Any other cause, including a significant underlying disease or disorder which, in the opinion of the investigator, may put the participant at risk by participating in the study or limit the participant's ability to participate.

Sponsors & Collaborators

• Perspectum: lead

Study Sites (2)

Mayo Clinic Healthcare

London, W1B 1PT, United Kingdom

Location

Gemini

Oxford, OX4 2LL, United Kingdom

Location

Related Publications (25)

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• Gurwitz D. Angiotensin receptor blockers as tentative SARS-CoV-2 therapeutics. Drug Dev Res. 2020 Aug;81(5):537-540. doi: 10.1002/ddr.21656. Epub 2020 Mar 4.

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• Harrison SA, Rossi SJ, Paredes AH, Trotter JF, Bashir MR, Guy CD, Banerjee R, Jaros MJ, Owers S, Baxter BA, Ling L, DePaoli AM. NGM282 Improves Liver Fibrosis and Histology in 12 Weeks in Patients With Nonalcoholic Steatohepatitis. Hepatology. 2020 Apr;71(4):1198-1212. doi: 10.1002/hep.30590. Epub 2019 Apr 10.

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• Pavlides M, Banerjee R, Sellwood J, Kelly CJ, Robson MD, Booth JC, Collier J, Neubauer S, Barnes E. Multiparametric magnetic resonance imaging predicts clinical outcomes in patients with chronic liver disease. J Hepatol. 2016 Feb;64(2):308-315. doi: 10.1016/j.jhep.2015.10.009. Epub 2015 Nov 10.

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• Pavlides M, Banerjee R, Tunnicliffe EM, Kelly C, Collier J, Wang LM, Fleming KA, Cobbold JF, Robson MD, Neubauer S, Barnes E. Multiparametric magnetic resonance imaging for the assessment of non-alcoholic fatty liver disease severity. Liver Int. 2017 Jul;37(7):1065-1073. doi: 10.1111/liv.13284. Epub 2017 May 30.

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• Verity R, Okell LC, Dorigatti I, Winskill P, Whittaker C, Imai N, Cuomo-Dannenburg G, Thompson H, Walker PGT, Fu H, Dighe A, Griffin JT, Baguelin M, Bhatia S, Boonyasiri A, Cori A, Cucunuba Z, FitzJohn R, Gaythorpe K, Green W, Hamlet A, Hinsley W, Laydon D, Nedjati-Gilani G, Riley S, van Elsland S, Volz E, Wang H, Wang Y, Xi X, Donnelly CA, Ghani AC, Ferguson NM. Estimates of the severity of coronavirus disease 2019: a model-based analysis. Lancet Infect Dis. 2020 Jun;20(6):669-677. doi: 10.1016/S1473-3099(20)30243-7. Epub 2020 Mar 30.

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• Dennis A, Cuthbertson DJ, Wootton D, Crooks M, Gabbay M, Eichert N, Mouchti S, Pansini M, Roca-Fernandez A, Thomaides-Brears H, Kelly M, Robson M, Hishmeh L, Attree E, Heightman M, Banerjee R, Banerjee A. Multi-organ impairment and long COVID: a 1-year prospective, longitudinal cohort study. J R Soc Med. 2023 Mar;116(3):97-112. doi: 10.1177/01410768231154703. Epub 2023 Feb 14.

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• Roca-Fernandez A, Dennis A, Nicholls R, McGonigle J, Kelly M, Banerjee R, Banerjee A, Sanyal AJ. Hepatic Steatosis, Rather Than Underlying Obesity, Increases the Risk of Infection and Hospitalization for COVID-19. Front Med (Lausanne). 2021 Mar 29;8:636637. doi: 10.3389/fmed.2021.636637. eCollection 2021.

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• Davis HE, McCorkell L, Vogel JM, Topol EJ. Long COVID: major findings, mechanisms and recommendations. Nat Rev Microbiol. 2023 Mar;21(3):133-146. doi: 10.1038/s41579-022-00846-2. Epub 2023 Jan 13.

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• Roca-Fernandez A, Wamil M, Telford A, Carapella V, Borlotti A, Monteiro D, Thomaides-Brears H, Kelly M, Dennis A, Banerjee R, Robson M, Brady M, Lip GYH, Bull S, Heightman M, Ntusi N, Banerjee A. Cardiac abnormalities in Long COVID 1-year post-SARS-CoV-2 infection. Open Heart. 2023 Feb;10(1):e002241. doi: 10.1136/openhrt-2022-002241.

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• Borlotti A, Thomaides-Brears H, Georgiopoulos G, Banerjee R, Robson MD, Fusco DN, Masci PG. The Additive Value of Cardiovascular Magnetic Resonance in Convalescent COVID-19 Patients. Front Cardiovasc Med. 2022 Apr 7;9:854750. doi: 10.3389/fcvm.2022.854750. eCollection 2022.

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• Dennis A, Wamil M, Alberts J, Oben J, Cuthbertson DJ, Wootton D, Crooks M, Gabbay M, Brady M, Hishmeh L, Attree E, Heightman M, Banerjee R, Banerjee A; COVERSCAN study investigators. Multiorgan impairment in low-risk individuals with post-COVID-19 syndrome: a prospective, community-based study. BMJ Open. 2021 Mar 30;11(3):e048391. doi: 10.1136/bmjopen-2020-048391.

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Related Links

• WHO. (2020, February 28). Report of the WHO-China Joint Mission on Coronavirus Disease (COVID-19).
• Parisinos CA, W. H. (2020). Genetic studies of magnetic resonance imaging of the liver implicate metal ion transporters in the pathogenesis of steatohepatitis in UK Biobank. J Hepatol
• COVID-19 Surveillance Group. (2020). Characteristics of COVID-19 patients dying in Italy: report based on available data on March 20th, 2020. : ; 2020. Rome, Italy: Instituto Superiore Di Sanita.
• Mapping Organ Health following COVID-19 Disease due to SARS-CoV-2 infection

Biospecimen

Retention: SAMPLES WITH DNA

The tests consist of complete blood count (CBC), biochemical profile (e.g., electrolyte and renal panel, liver serum biochemistry) and stored serum/plasma. Genetic testing for genetic variants associated with this disease will also be carried out if the participant gives informed consent for genetic testing.

MeSH Terms

Conditions

COVID-19; Metabolic Syndrome; Obesity; Non-alcoholic Fatty Liver Disease

Interventions

Genotype; Body Height; Blood Pressure

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Genetic Phenomena; Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Appearance, Body; Anthropometry; Investigative Techniques; Physiological Phenomena; Growth; Growth and Development; Vital Signs; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Rajarshi Banerjee, MSc, DPhil

  Honorary Consultant Physician, Oxford University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 30, 2020
• Study Start: April 21, 2020
• Primary Completion: April 19, 2022
• Study Completion: April 19, 2022
• Last Updated: December 5, 2025

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)