An observational study in Covid19, Coronavirus Infection and SARS-CoV Infection, sponsored by University of Alberta. Completed at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-26.
Sponsored by University of Alberta · Observational
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 215 is below the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.
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Adult participants with new or recent COVID-19 infection.
Troponin substudy Inclusion Criteria:
Troponin substudy Exclusion Criteria:
Late cross-sectional substudy Inclusion Criteria:
Late cross-sectional substudy Exclusion Criteria:
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) · Diagnostic Test: Bloodwork · Other: Cognitive testing · Other: Olfaction testing · Diagnostic Test: Spirometry · Other: Walk Test
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) · Diagnostic Test: Bloodwork · Other: Cognitive testing · Other: Olfaction testing · Diagnostic Test: Spirometry · Other: Walk Test
MRI (heart, brain, lungs, liver)
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
NIH toolbox Cognitive Measures
Brief Smell Identification Test (BSIT)
Spirometry to evaluate forced expiratory volume in 1 second and forced vital capacity
Walk test to record overall distance walked in 6 minutes and time taken to walk the first 25 feet
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
Time frame: 12 weeks post COVID-19 diagnosis
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
Time frame: 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
Time frame: 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
Time frame: 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
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
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 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
Time frame: 12-24 weeks post COVID-19 diagnosis
Plan to share: Undecided
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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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University of Alberta