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NCT Number: NCT04525404

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infection Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV Infection Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Calgary, Calgary, Alberta, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Troponin substudy Inclusion Criteria:

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

Troponin substudy Exclusion Criteria:

  • Contraindication to MRI or MRI contrast
  • GFR < 30ml/kg/min/1.73m2
  • Hemodynamic instability requiring inotropic agents
  • Active ventilatory support

Late cross-sectional substudy Inclusion Criteria:

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

Late cross-sectional substudy Exclusion Criteria:

  • Contraindication to MRI or MRI contrast

Treatment and study plan

MRI (heart, brain, lungs, liver)

Diagnostic Test

MRI (heart, brain, lungs, liver)

Bloodwork

Diagnostic Test

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

Cognitive testing

Other

NIH toolbox Cognitive Measures

Olfaction testing

Other

Brief Smell Identification Test (BSIT)

Spirometry

Diagnostic Test

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

Walk Test

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Canadian VIGOUR Centre

Registry information

Acronym: MOIST

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Aug 25, 2020
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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