Lung Structure-Function In Survivors of Mild and Severe COVID-19 Infection (LIVECOVIDFREE)

Western University, Canada

Status: Active, not recruiting

Conditions: Covid19

Treatments: Other: Questionnaires; Diagnostic Test: Blood analysis; Diagnostic Test: Pulmonary Function Tests (PFT); Diagnostic Test: Sputum analysis; Diagnostic Test: Computed Tomography (CT); Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungs; Diagnostic Test: Six Minute Walk Test (6MWT)

Study type: Observational

Funder types: Other

Identifiers

NCT04584671

ROB0050

Details and patient eligibility

About

This is a longitudinal study of the long-term impact of COVID-19 on the lungs. Participants will be followed over a period of up to 4 years and impacts of COVID-19 on the lungs will be measured with magnetic resonance imaging (MRI) using hyperpolarized xenon-129, pulmonary function tests, exercise capacity, computed tomography imaging and questionnaires.

Full description

This is a multisite longitudinal study of the long-term lung health impact of COVID-19 using hyperpolarized xenon-129 (129Xe) magnetic resonance imaging (MRI) over a period of up to 4 years.

In total 200 participants age ≥ 18 and <80 years who experienced a documented case of COVID-19 (documented by positive COVID-19 test and/or clinical history) will be screened and recruited if they meet all inclusion criteria at the 5 participating sites. Participants will be grouped in mild or severe COVID-19 infection (100 in each group) including 50 with symptoms and at least 50 participants who were hospitalized with COVID-19 infection, all of whom are within 3 months post recovery and non-infectious. Participants will attend up to 5 study visits over the 4 year period. (Visit 1 within 3 months post-COVID-19 recovery, Visit 2 at 24 ± 4 weeks, Visit 3 at 48 ± 4 weeks, Visit 4 at 78 ± 4 weeks, Visit 5 at 200 ± 16 weeks)

At all visits, participants will complete 129Xe MRI, questionnaires (St. George's Respiratory Questionnaire, COPD Assessment Test, Modified Medical Research Council Dyspnea Scale, Modified Borg Scale Breathlessness and Fatigue Questionnaire, Baseline Dyspnea Index Questionnaire and International Physical Activity Questionnaire), pulmonary function tests (Spirometry, Plethysmography, Forced Oscillation Technique, Fractional Exhaled Nitric Oxide, and Multiple Breath Nitrogen Washout), blood and sputum analysis, exercise testing (six-minute walk test). At Visit 1, participants will also complete computed tomography imaging at University Hospital, London Health Sciences Centre. Visits 2 and 4 have the option of being completed over the phone, in which case only questionnaires will be completed. Visit 5 is an optional 4-year follow-up.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who are fluent in English reading, understanding and speaking
• Written informed consent must be directly obtained from legally competent participants before any study-related assessment is performed.
• Male and female participants ≥ 18 years and < 80 years.
• Participant experienced a documented case (documented by positive COVID-19 test and/or clinical history) of mild or severe COVID-19 infection.
• Participants are within 3 months post-recovery.
• 100 participants will have had mild symptoms.
• 100 participants will have had severe symptoms, at least 50 of whom were hospitalized.

Exclusion criteria

• Participants meeting contraindications for undergoing an MRI such as participants with MRI-sensitive implants, tattoos with MRI-sensitive dye and severe claustrophobia.
• Participant is, in the opinion of the Investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand written material.
• Participant is unable to perform spirometry or plethysmography maneuvers.

Trial design

100 participants in 2 patient groups

Mild COVID-19 Infection Group

Description:

100 participants age ≥ 18 and \<80 years who experienced a documented case (documented by positive COVID-19 test and/or clinical history) of mild COVID-19 infection, all of whom are within 3 months post recovery and non-infectious.

Treatment:

Diagnostic Test: Blood analysis

Diagnostic Test: Six Minute Walk Test (6MWT)

Other: Questionnaires

Diagnostic Test: Computed Tomography (CT)

Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungs

Diagnostic Test: Pulmonary Function Tests (PFT)

Diagnostic Test: Sputum analysis

Severe COVID-19 Infection Group

Description:

100 participants age ≥ 18 and \<80 years who experienced a documented case (documented by positive COVID-19 test and/or clinical history) of severe COVID-19 infection, including at least 50 participants who were hospitalized with COVID-19 infection, all of whom are within 3 months post recovery and non-infectious.

Treatment:

Diagnostic Test: Blood analysis

Diagnostic Test: Six Minute Walk Test (6MWT)

Other: Questionnaires

Diagnostic Test: Computed Tomography (CT)

Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungs

Diagnostic Test: Pulmonary Function Tests (PFT)

Diagnostic Test: Sputum analysis