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Covid19MOISTNCT04525404

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

An observational study of Covid19 and Coronavirus Infection, run by University of Alberta at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19, Coronavirus Infection, SARS-CoV Infection
What is being tested?
MRI (heart, brain, lungs, liver), Bloodwork and Cognitive testing
How many people
215 participants
Where
2 sitesCanada
Study dates
12 Nov 2020to 30 Sep 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult participants with new or recent COVID-19 infection.

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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • University of Calgary

    Calgary, Alberta

  • University of Alberta

    Edmonton, Alberta

Other trials in Canada

About this study

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.

Read more

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.

Read the detailed description

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.

Being tested
MRI (heart, brain, lungs, liver), Bloodwork, Cognitive testing, Olfaction testing, Spirometry
Medical subject headings
COVID-19, Coronavirus Infections, Severe Acute Respiratory Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRI (heart, brain, lungs, liver)Diagnostic test

    MRI (heart, brain, lungs, liver)

  • BloodworkDiagnostic 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 testingOther

    NIH toolbox Cognitive Measures

  • Olfaction testingOther

    Brief Smell Identification Test (BSIT)

  • SpirometryDiagnostic test

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

  • Walk TestOther

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

Study groups in NCT04525404
Study groupRoleWhat they receive
Troponin SubstudyParticipants 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.
Receives: Diagnostic Test: MRI (heart, brain, lungs, liver); Diagnostic Test: Bloodwork; Other: Cognitive testing; Other: Olfaction testing; Diagnostic Test: Spirometry; Other: Walk Test
Late Cross-Sectional SubstudyParticipants 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.
Receives: Diagnostic Test: MRI (heart, brain, lungs, liver); Diagnostic Test: Bloodwork; Other: Cognitive testing; Other: Olfaction testing; Diagnostic Test: Spirometry; Other: Walk Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Native myocardial T1 relaxation time

    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

    Measured: 12 weeks post COVID-19 diagnosis

Secondary outcomes (6)

  1. FLAIR imaging

    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

    Measured: 12 weeks post COVID-19 diagnosis

  2. Compare 12-week cognitive testing to the corresponding findings on MRI of brain, heart and lung at baseline

    Compare 12-week cognitive testing (NIH toolbox score) to the corresponding findings on MRI of brain, heart and lung at baseline

    Measured: 12 weeks post COVID-19 diagnosis

  3. Compare 12-week spirometry to the corresponding findings on MRI of brain, heart and lung at baseline

    Compare 12-week spirometry (FEV1, FVC and FEV1:FVC) to the corresponding findings on MRI of brain, heart and lung at baseline

    Measured: 12 weeks post COVID-19 diagnosis

  4. Compare 12-week walk test results to the corresponding findings on MRI of brain, heart and lung at baseline

    Compare 12-week walk test results (distance and time) to the corresponding findings on MRI of brain, heart and lung at baseline

    Measured: 12 weeks post COVID-19 diagnosis

  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

    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

    Measured: 12 weeks post COVID-19 diagnosis

  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

    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

    Measured: 12-24 weeks post COVID-19 diagnosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2020
  2. Study start12 Nov 2020
  3. Primary completion22 Sep 2021
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04525404
Sponsor's protocol ID
Pro00102389
Acronym
MOIST
Status last verified
Sep 2022
First submitted
17 Aug 2020
Last updated
26 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Paterson DI, White JA, Beaulieu C, Sherrington R, Prado CM, Tandon P, Halloran K, Smith S, McCombe JA, Ritchie B, Pituskin E, Haykowsky MJ, Coulden R, Emery D, Tsui AK, Wu KY, Oudit GY, Ezekowitz JA, Thompson RB. Rationale and design of the multi organ inflammation with serial testing study: a comprehensive assessment of functional and structural abnormalities in patients with recovered COVID-19. Front Med (Lausanne). 2024 Jul 24;11:1392169. doi: 10.3389/fmed.2024.1392169. eCollection 2024.

    PubMed 39114821

  • Crosier R, Kafil TS, Paterson DI. Imaging for Cardiovascular Complications of COVID-19: Cardiac Manifestations in Context. Can J Cardiol. 2023 Jun;39(6):779-792. doi: 10.1016/j.cjca.2023.01.022. Epub 2023 Jan 31.

    PubMed 36731604

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and Coronavirus Infection, run by University of Alberta at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Native myocardial T1 relaxation time (time frame: 12 weeks post COVID-19 diagnosis). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04525404, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.

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MOIST Clinical Trial NCT04525404 | AzTrials