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

Covid19 Clinical Trial

— MOIST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04525404
• Other study ID #: Pro00102389
• Status: Completed
• Start date: November 12, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: September 30, 2022
• Est. primary completion date: September 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infection
• Coronavirus Infections
• COVID-19
• Covid19
• Infections
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Diagnostic Test:
• MRI (heart, brain, lungs, liver)
MRI (heart, brain, lungs, liver)
• 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
• 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

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Canadian VIGOUR Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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