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

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.

Study Overview

• Status: Completed
• Conditions: Coronavirus Infection; Covid19; SARS-CoV Infection
• Intervention / Treatment: Diagnostic test: MRI (heart, brain, lungs, liver); 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, 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.

• Study Type: Observational
• Enrollment (Actual): 215

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • University of Calgary
    • Edmonton, Alberta, Canada
      • University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult participants with new or recent COVID-19 infection.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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, liver); MRI (heart, brain, lungs, liver); 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, liver); MRI (heart, brain, lungs, liver); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 weeks post COVID-19 diagnosis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 weeks post COVID-19 diagnosis
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	12 weeks post COVID-19 diagnosis
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	12 weeks post COVID-19 diagnosis
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	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	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	12 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	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	12-24 weeks post COVID-19 diagnosis

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Canadian VIGOUR Centre

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2020
• Primary Completion (Actual): September 22, 2021
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (Actual): August 25, 2020

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Severe Acute Respiratory Syndrome; COVID-19; Coronavirus Infections; Infections; Communicable Diseases
• Other Study ID Numbers: Pro00102389

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No