Clinical trial NCT04525404: MOIST Study: Multi-Organ Imaging With Serial Testing in COVID-19 Infected Patients
Official title: MOIST Study: Multi-Organ Imaging With Serial Testing in COVID-19 Infected Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Coronavirus Infection
SARS-CoV Infection
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Canadian VIGOUR Centre
First posted: 2020-08-25
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with new or recent COVID-19 infection.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Native myocardial T1 relaxation time
timeFrame: 12 weeks post COVID-19 diagnosis
Secondary outcomes:
measure: FLAIR imaging
timeFrame: 12 weeks post COVID-19 diagnosis
measure: Compare 12-week cognitive testing to the corresponding findings on MRI of brain, heart and lung at baseline
timeFrame: 12 weeks post COVID-19 diagnosis
measure: Compare 12-week spirometry to the corresponding findings on MRI of brain, heart and lung at baseline
timeFrame: 12 weeks post COVID-19 diagnosis
measure: Compare 12-week walk test results to the corresponding findings on MRI of brain, heart and lung at baseline
timeFrame: 12 weeks post COVID-19 diagnosis
measure: 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
timeFrame: 12 weeks post COVID-19 diagnosis
measure: 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
timeFrame: 12-24 weeks post COVID-19 diagnosis
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Ian Paterson, MD
role: PRINCIPAL_INVESTIGATOR
References: