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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369807
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Perspectum

Tracking Information
First Submitted Date April 22, 2020
First Posted Date April 30, 2020
Last Update Posted Date April 30, 2020
Actual Study Start Date April 21, 2020
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 29, 2020)
Characterise prevalence and severity of organ volume change and damage (heart, kidneys and liver) [ Time Frame: 12 Months ]
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 29, 2020)
  • Characterise prevalence and severity of organ volume change and damage (lung, pancreas and spleen) [ Time Frame: 12 Months ]
    In patients recovering from COVID-19 disease: To characterise using summary statistics the prevalence and severity of organ volume change and damage in lung, pancreas and spleen
  • Change from Baseline in liver-specific biomarkers: volume, iron corrected T1(cT1), fat content and T2star [ Time Frame: 6 Months ]
    In patients recovering from COVID-19 disease: Characterise liver damage as assessed by liver volume in liters, iron corrected T1 (cT1) in milliseconds, liver fat content as %, liver T2star in milliseconds (a correlate of liver iron content)
  • 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 [ Time Frame: 12 Months ]
    In patients recovering from COVID-19 disease: Characterise heart and spleen damage as assessed by liver volume in liters as well as kidney, liver and pancreas damage as assessed by volume in liters, iron corrected T1 (cT1) in milliseconds, fat infiltration as %, T2star in milliseconds (a correlate of liver iron content).
  • Change in patient reported outcome measured by the Dyspnea-12 questionnaire [ Time Frame: 12 Months ]
    In patients recovering from COVID-19 disease: Change in patient reported outcome measures collected to assess breathlessness and its effect on overall health and daily life assessed by Dyspnea-12. Each question is assigned a value between: none, mild, moderate and severe and is used to assess breathing characteristics.
  • Change in patient reported outcome measured by the St. George's Respiratory questionnaire (SGRQ) [ Time Frame: 12 Months ]
    In patients recovering from COVID-19 disease: Change in patient reported outcome measures collected to assess breathlessness and its effect on overall health and daily life assessed by the St. George's Respiratory questionnaire. Each section comprises of questions in various formats allowing to assess which aspects of the illness cause the participant the most problems in daily life.
  • Change in patient reported outcome measured by the EQ-5D-5L questionnaire [ Time Frame: 12 Months ]
    In patients recovering from COVID-19 disease: Change in patient reported outcome measures collected to assess breathlessness and its effect on overall health and daily life assessed by the EQ-5D-5L questionnaire. Two main sections provide the opportunity to capture statements best describing a participant's daily health and a scale form 0 to 100 capturing self-reported health stats. (100 being the best health imaginable and vice versa)
  • Degree of change in liver MR-derived biomarkers [ Time Frame: 12 Months ]
    In patients recovering from COVID-19 disease: Difference from Baseline in degree of change in liver MR-derived biomarkers with and without known genetic variants associated with liver disease (e.g., PNPLA3) using a paired t-test (or non-parametric alternative)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mapping Organ Health Following COVID-19 Disease Due to SARS-CoV-2 Infection
Official Title Mapping Organ Health Following COVID-19 Disease Due to SARS-CoV-2 Infection
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.
Detailed Description

To date, correctly, all of the Government's efforts have been dedicated to providing sufficient hospital space, and the appropriate equipment, for treating the most serious cases of COVID-19. Equally, enormous resource is being dedicated to developing technologies that determine who has the disease, and who has developed antibodies to it.

However, patients recovering from serious disease will also pose a huge, ongoing challenge. Not only are people with co-morbidities including underlying fatty liver disease, metabolic syndrome and diabetes at higher risk for complications with COVID-19; but patients discharged from hospital after severe COVID-19 are reported to have liver and kidney injuries, and impacts on pancreas and spleen. However, the extent of organ health/damage has not been mapped.

This is a prospective, longitudinal, observational cohort study looking at patients recovering from COVID-19 disease using multi-parametric magnetic resonance imaging (MRI) to assess the degree and prevalence of organ injury. This proposed study aims to measure the prevalence of organ volume changes and damage in lungs, heart, kidney, liver, pancreas, spleen as assessed by MRI among those having recovered, or recovering, from the SARS-CoV-2 infection - participants will have a final MRI scan at 12 months. Assessing the severity and sequelae of COVID-19 in patients is crucial to enable global planning for health-care needs. The study includes up to 3 visits for MRI scans and blood tests over a 12 month period. All participants will receive standard-of-care by their healthcare provider/s.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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.

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.
Condition COVID-19
Intervention Diagnostic Test: Outpatient MRI

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.

Other Names:
  • Outpatient blood tests for laboratory studies and genotyping
  • Outpatient measurements (height, weight, blood pressure)
  • Online Questionnaires
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 29, 2020)
507
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2023
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mary Norris Xu, BSc, RN 01865655343 mary.xu@perspectum.com
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04369807
Other Study ID Numbers 20/SC/0185
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description:

Access to study data and/or results will be granted to Health Data Research UK (HDRUK), Public Health England (PHE) and to the World Health Organization (WHO).

Furthermore, at the end of the study, the pooled and anonymous results of the questionnaires will be available to all participants upon their request. No individual participant will be identified.

Responsible Party Perspectum
Study Sponsor Perspectum
Collaborators Not Provided
Investigators
Principal Investigator: Rajarshi Banerjee, MSc, DPhil Honorary Consultant Physician, Oxford University NHS Foundation Trust
PRS Account Perspectum
Verification Date April 2020