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

University of Alberta

Status: Completed

Conditions: SARS-CoV Infection; Covid19; Coronavirus Infection

Treatments: Other: Cognitive testing; Diagnostic Test: MRI (heart, brain, lungs, liver); Diagnostic Test: Bloodwork; Diagnostic Test: Spirometry; Other: Olfaction testing; Other: Walk Test

Study type: Observational

Funder types: Other

Identifiers

NCT04525404

Pro00102389

Details and patient eligibility

About

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.

Full 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.

Enrollment: 215 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

215 participants in 2 patient groups

Troponin Substudy

Description:

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.

Treatment:

Diagnostic Test: Spirometry

Other: Cognitive testing

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

Other: Olfaction testing

Other: Walk Test

Diagnostic Test: Bloodwork

Late Cross-Sectional Substudy

Description:

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.

Treatment:

Diagnostic Test: Spirometry

Other: Cognitive testing

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

Other: Olfaction testing

Other: Walk Test

Diagnostic Test: Bloodwork