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MOIST Study: Multi-Organ Imaging With Serial Testing in COVID-19 Infected Patients (MOIST)

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: NCT04525404
Recruitment Status : Not yet recruiting
First Posted : August 25, 2020
Last Update Posted : September 24, 2020
Sponsor:
Collaborator:
Canadian VIGOUR Centre
Information provided by (Responsible Party):
University of Alberta

Brief Summary:

While many people with COVID-19 suffer from respiratory disease, there is growing evidence that the virus also affects other organs. The purpose of this study is to better understand the effects of COVID-19 on the lungs and other organs.

The study investigators have developed new techniques in Magnetic Resonance Imaging (MRI) to scan the lungs, heart, brain and liver. The study investigators hope to learn more about how the virus causes inflammation in these organs and how this inflammation changes over time as people recover from COVID-19 illness.

The study aims to enroll 228 people in Alberta. Participants will undergo one or more MRI scans and have blood testing at one or more time points to assess for inflammation, kidney function, liver function and possible heart injury. Participants will also undergo testing to assess sense of smell, cognition (thinking and memory), spirometry (breathing test for lung function) and and exercise tolerance (walk test).

The study investigators hope this study will help us learn more about the long-term risks of COVID-19 disease.


Condition or disease Intervention/treatment
Covid19 Coronavirus Infection SARS-CoV Infection Diagnostic Test: MRI (heart, brain, lungs, kidney) Diagnostic Test: Bloodwork Other: Cognitive testing Other: Olfaction testing Diagnostic Test: Spirometry Other: Walk Test

Detailed Description:
Participants with newly or recently diagnosed COVID-19 infection (inpatients and outpatients) will undergo multi-organ MRI (heart, brain, lungs, kidney), blood work, and functional testing at one or more time points. Functional testing will include olfaction testing, cognitive testing, spiromety, and a walk test.

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Study Type : Observational
Estimated Enrollment : 228 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MOIST Study: Multi-Organ Imaging With Serial Testing in COVID-19 Infected Patients
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Troponin Substudy
Participants with new COVID-19 infection will undergo high-sensitivity Troponin testing; participants with elevated Troponin will undergo MRI, bloodwork, and olfaction testing at Baseline, then repeat MRI, bloodwork and all functional testing at the Recovered (ie 12weeks post diagnosis) phase. Participants with normal Troponin will undergo only olfaction testing and bloodwork at baseline, then MRI, bloodwork and all functional testing at the Recovered phase.
Diagnostic Test: MRI (heart, brain, lungs, kidney)
MRI (heart, brain, lungs, kidney)

Diagnostic Test: Bloodwork
Serum biomarkers to assess systemic inflammation, renal function, cardiac injury, liver injury and steatosis, ACE-2 related peptides, cytokines, Activin A and autoantibodies to cardiac antigens, humoral cell RNA

Other: Cognitive testing
NIH toolbox Cognitive Measures

Other: Olfaction testing
Brief Smell Identification Test (BSIT)

Diagnostic Test: Spirometry
Spirometry to evaluate forced expiratory volume in 1 second and forced vital capacity

Other: Walk Test
Walk test to record overall distance walked in 6 minutes and time taken to walk the first 25 feet

Late Cross-Sectional Substudy
Participants with a COVID-19 diagnosis at least 3 months prior to enrollment will undergo MRI, bloodwork and all functional testing at the Recovered phase only.
Diagnostic Test: MRI (heart, brain, lungs, kidney)
MRI (heart, brain, lungs, kidney)

Diagnostic Test: Bloodwork
Serum biomarkers to assess systemic inflammation, renal function, cardiac injury, liver injury and steatosis, ACE-2 related peptides, cytokines, Activin A and autoantibodies to cardiac antigens, humoral cell RNA

Other: Cognitive testing
NIH toolbox Cognitive Measures

Other: Olfaction testing
Brief Smell Identification Test (BSIT)

Diagnostic Test: Spirometry
Spirometry to evaluate forced expiratory volume in 1 second and forced vital capacity

Other: Walk Test
Walk test to record overall distance walked in 6 minutes and time taken to walk the first 25 feet




Primary Outcome Measures :
  1. Native myocardial T1 relaxation time [ Time Frame: 12 weeks post COVID-19 diagnosis ]
    Myocardial T1 is a surrogate marker of myocardial edema and the most sensitive MRI measure of acute myocarditis. We will show that myocardial T1 at baseline is significantly higher than myocardial T1 at 12 weeks follow-up. At 12 weeks, we will also compare native myocardial T1 in patients with baseline elevated troponin to those with baseline normal troponin as well as healthy controls


Secondary Outcome Measures :
  1. FLAIR imaging [ Time Frame: 12 weeks post COVID-19 diagnosis ]
    Similar within group and between group comparisons of MRI derived lung water content, liver water content, and the presence of brain inflammation on FLAIR imaging

  2. Compare 12-week cognitive testing to the corresponding findings on MRI of brain, heart and lung at baseline [ Time Frame: 12 weeks post COVID-19 diagnosis ]
    Compare 12-week cognitive testing (NIH toolbox score) to the corresponding findings on MRI of brain, heart and lung at baseline

  3. Compare 12-week spirometry to the corresponding findings on MRI of brain, heart and lung at baseline [ Time Frame: 12 weeks post COVID-19 diagnosis ]
    Compare 12-week spirometry (FEV1, FVC and FEV1:FVC) to the corresponding findings on MRI of brain, heart and lung at baseline

  4. Compare 12-week walk test results to the corresponding findings on MRI of brain, heart and lung at baseline [ Time Frame: 12 weeks post COVID-19 diagnosis ]
    Compare 12-week walk test results (distance and time) to the corresponding findings on MRI of brain, heart and lung at baseline

  5. Compare 12-week cognitive testing in patients with normal smell and/or normal appearing brainstem on MRI to patients with no or impaired smell and/or injury to brainstem on MRI [ Time Frame: 12 weeks post COVID-19 diagnosis ]
    Compare 12-week cognitive testing in patients with normal smell and/or normal appearing brainstem on MRI to patients with no or impaired smell and/or injury to brainstem on MRI

  6. Compare MRI measures of organ dysfunction at 12-24 weeks in survivors according to severity of prior COVID-19 illness: (i) hospitalized, (ii) symptomatic, not hospitalized and (iii) asymptomatic [ Time Frame: 12-24 weeks post COVID-19 diagnosis ]
    Compare MRI measures of organ dysfunction at 12-24 weeks in survivors according to severity of prior COVID-19 illness: (i) hospitalized, (ii) symptomatic, not hospitalized and (iii) asymptomatic



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult participants with new or recent COVID-19 infection.
Criteria

Troponin substudy Inclusion Criteria:

  1. 18 years of age or older
  2. Willing and able to provide informed consent
  3. COVID-19 positive test (within 14 days of positive test date)
  4. High-sensitivity Troponin-I >100ng/L or Troponin T > 52ng/L
  5. Ability to obtain Baseline MRI imaging within 7 days (up to 14 days maximum) of Troponin result

Troponin substudy Exclusion Criteria:

  1. Contraindication to MRI or MRI contrast
  2. GFR < 30ml/kg/min/1.73m2
  3. Hemodynamic instability requiring inotropic agents
  4. Active ventilatory support

Late cross-sectional substudy Inclusion Criteria:

  1. 18 years of age or older
  2. Willing and able to provide informed consent
  3. Previously diagnosed with COVID-19 > 3 months ago
  4. Ability to obtain MRI imaging at minimum 12 weeks from COVID-19 diagnosis

Late cross-sectional substudy Exclusion Criteria:

  1. Contraindication to MRI or MRI contrast
  2. GFR < 30ml/kg/min/1.73m2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04525404


Contacts
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Contact: Ian Paterson, MD 780-407-1857 ip3@ualberta.ca
Contact: Karin Kushniruk, RN, PhD 780-492-8476 karin.kushniruk@ualberta.ca

Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada
Contact: Ian Paterson, MD    780-407-1857    ip3@ualberta.ca   
Sponsors and Collaborators
University of Alberta
Canadian VIGOUR Centre
Investigators
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Principal Investigator: Ian Paterson, MD University of Alberta
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT04525404    
Other Study ID Numbers: Pro00102389
First Posted: August 25, 2020    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases