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

Overview

Sample Size: n=570 Accrual Ceiling: n=627 Study Population: Patients age 18 to 100 years The study duration includes 51 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. Participant Cohorts: 1. Individuals who had previous asymptomatic or mild COVID-19 (mild=never required supplemental oxygen during the acute phase of the infection) 2. Individuals 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) 3. Individuals 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 4. Individuals who have not had COVID-19 (i.e. individuals who tested negative for COVID-19 and who never had symptoms consistent with COVID-19)

Primary Objectives: 1. Evaluate the short- and long-term end-organ complications post-COVID-19 in relation to the severity of the acute COVID-19 infection. 2. Establish a post-COVID-19 biobank. Secondary Objectives: 1\) Develop a model 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: 1. 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. 2. An increase in liver enzymes \> 2 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). 3. Any change in pre-COVID-19 weight, waist circumference or body mass composition. 4. Any change in 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. 5. A positive fecal calprotectin or lactoferrin measurement occurring \>4 weeks after COVID-19 symptom-onset or diagnosis. 6. 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. 7. Any change in dietary habits (nutritional quantity and quality) as measured by the Food Frequency Questionnaire, in physical activity as measured by actimeter reading, and/or well-being as measured by our Well-Being Questionnaire. Methodology: Individuals 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 individuals 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 * Actimeter reading * Pulmonary function test * Echocardiography * Electrocardiogram * Urine collection * Blood draw * Saliva collection * Stool collection (optional) * Nasopharyngeal swab (optional)