Institut de Recherche Cliniques de Montreal (IRCM) Post-COVID-19 (IPCO) Research Clinic

Study Overview
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Brief Summary
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Sample Size: n=570 Accrual Ceiling: n=627 Study Population: Patients age 18 to 100 years Accrual Period: February 1, 2021 to September 30, 2022 Study Duration: Start Date: January 1, 2021 End Date: March 1, 2025 The study duration includes 18 months to recruit patients and 24 months of total follow-up time counted from the first day of COVID-19 symptoms or date of confirmed COVID-19 diagnosis. Study Design: This is a prospective, observational cohort study to evaluate the short- and long-term end-organ complications of COVID-19 and to establish a COVID-19 biobank. Patient Cohorts: Patients who had previous asymptomatic or mild COVID-19 (mild=never required supplemental oxygen during the acute phase of the infection) Patients who had previous moderate or severe COVID-19 (moderate=required supplemental oxygen by nasal cannula during the acute phase of the infection; severe=required supplemental oxygen by either high-flow nasal cannula, non-invasive positive pressure ventilation or intubation) Patients who had COVID-19 but did not have signs or symptoms related to COVID-19 lasting beyond 4 weeks from the date of COVID-19 symptom-onset or diagnosis Patients who have not had COVID-19 (i.e. patients who tested negative for COVID-19 and who never had symptoms consistent with COVID-19)

Detailed Description
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Primary Objectives: Evaluate the short- and long-term end-organ complications post-COVID-19 in relation to the severity of the acute COVID-19 infection. Establish a post-COVID-19 biobank. Secondary Objectives: 1) Develop a model based that may predict the development of end-organ complications. Primary Endpoint: The development of any end-organ complication that can plausibly be related to COVID-19. Secondary Endpoints: Detection of any new abnormality on echocardiogram >4 weeks after COVID-19 symptom-onset or diagnosis. Detection of any new abnormality on pulmonary function testing (PFT) or any change in PFT compared to a pre- or post-COVID-19 baseline PFT. An increase in liver enzymes > 3 times upper limit of normal that occurs post-COVID-19 and is not associated to any other process (e.g. cholestasis, drug toxicity, alcohol abuse, hepatitis A, B, C, D, E). Any change in pre-COVID-19 weight, waist circumference or body mass composition. Any change in blood glucose, continuous glucose monitoring (CGM), Glycated hemoglobin (HgA1C), lipid profile, thyroid stimulating hormone (TSH), T4 from pre-COVID-19 baseline that begins or persists >4 weeks after COVID-19 symptom-onset or diagnosis. A positive fecal calprotectin or lactoferrin measurement occurring >4 weeks after COVID-19 symptom-onset or diagnosis. Any significant change in renal parameters (e.g. micro-albuminuria, serum creatinine, glomerular filtration rate [GFR]) detected >4 weeks after COVID-19 symptom-onset or diagnosis. Any change in dietary habits (nutritional quantity and quality) as measured by the Food Frequency Questionnaire, in physical activity as measured by pedometer reading, and/or well-being as measured by our Well-Being Questionnaire. Any impact on neuro-psychological parameters. Methodology: Patients diagnosed with COVID-19 (for more than 28 days) will have up to 5 medical visits (depending on the time since diagnosis) over the course of 24 months from the date of COVID-19 symptom onset or diagnosis. COVID-19 negative patients will have up to 3 medical visits. The data will be collected for clinical monitoring and biobanking purposes. Medical visits include: Clinical assessment Epidemiological questionnaire Well-being questionnaire Food frequency questionnaire Physical exam (if indicated) Vital signs Measurement of waist circumference Weight and height measurement Impedance / evaluation of body mass composition Pedometer reading (worn for 7 days continuously) Continuous glucose monitoring (monitor worn for 14 days continuously) Pulmonary function test Echocardiography Electrocardiogram Urine collection Blood draw Saliva collection Stool collection (optional) Nasopharyngeal swab (optional)

Official Title
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IRCM Post-COVID-19 (IPCO) Research Clinic: a Multidisciplinary Approach to Evaluate Short and Long-term Complications of COVID-19

Conditions
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Covid19

Intervention / Treatment
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* Other: Medical follow-up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any gender, ≥ 18 years old Current resident of Quebec Speaks English or French AND 1 of the following criteria: COVID-19 positive test Household members of a case who has tested positive for COVID-19 IRCM patients with a negative COVID-19 test result Health care provider with a negative COVID-19 test result Exclusion Criteria: Any participant not deemed appropriate for enrollment according to the PI Known pregnancy (female will not be automatically screened for pregnancy upon enrollment unless there is a possibility that they might be pregnant)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 positive patients<br>Patients who had previous asymptomatic or mild COVID-19 (mild=never required supplemental oxygen during the acute phase of the infection) Patients who had previous moderate or severe COVID-19 (moderate=required supplemental oxygen by nasal cannula during the acute phase of the infection; severe=required supplemental oxygen by either high-flow nasal cannula, non-invasive positive pressure ventilation or intubation Patients who had COVID-19 but did not have signs or symptoms related to COVID-19 lasting beyond 4 weeks from the date of COVID-19 symptom-onset or diagnosis | Other: Medical follow-up<br>* Patients will be followed for medical evaluation and for biobanking of data and biological samples.<br>* Other names: Sample collection;|
| COVID-19 negative patients<br>COVID-19 negative control group | Other: Medical follow-up<br>* Patients will be followed for medical evaluation and for biobanking of data and biological samples.<br>* Other names: Sample collection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the short- and long-term end-organ complications post-COVID-19 in relation to the severity of the acute COVID-19 infection. |  | 2 years | 
| Establish a post-COVID-19 biobank. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The development of any end-organ complication that can plausibly be related to COVID-19. We will evaluate the following end-organ systems: neurological, cardiovascular, pulmonary, renal, endocrine and metabolic, gastro-intestinal (GI). |  | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-COVID-19 syndrome, COVID-19-related long-term complications, COVID-19 long haulers, Post-COVID-19 condition, Post-acute sequelae of COVID-19