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

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:

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:

• 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 > 2X 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 HgA1C, lipid profile or thyroid stimulating hormone (TSH) 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 physical activity and/or exercise tolerance as measured by actimeter reading or 6-minute walk test (6MWT) with ambulatory oximetry
• Any change in well-being as measured by our WHO Well-Being Questionnaire
• Any change in functional status as measured with the Post COVID-19 Functional Status Scale (PCFS)
• Any change in quality of life, as measured by the European Quality of Life 5 Dimensions (EQ-5D-5L) tool
• Any detection or exacerbation of post-exertional malaise (PEM)/post-exertional symptom exacerbation (PESE) using the DePaul Symptom Questionnaire - Post-exertional malaise (DSQ-PEM) short form and the FUNCAP27 questionnaire
• Any detection of new (i.e., not known to be present prior to COVID-19 infection) cardiac dysautonomia using the 10-minute standing test.

Methodology:

Participants will have up to 5 medical visits (depending on the time since diagnosis and group) over the course of 60 months. The data will be collected for clinical monitoring and biobanking purposes.

Medical visits include:

• Clinical assessment
• Epidemiological questionnaire
• Well-being 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
• Sebum collection
• Stool collection (optional)
• Nasopharyngeal swab (optional)

Inclusion criteria

• Any gender, ≥ 18 years old
• Current resident of Quebec
• Speaks English or French
• Have a personal email (to which to send reminders and questionnaire by email )

AND

1 of the following criteria:

• Individuals with at least one COVID-19 positive PCR test, serology or antibody/antigen test in the last 60 months at day of recruitment. In the absence of a positive COVID-19 test, individuals with symptoms consistent with COVID-19 while living with a person who had a confirmed positive PCR, serology or antibody/antigen COVID-19 test in the last 60 months at day of recruitment (epidemiologic link).

OR

• Individuals who tested negative for COVID-19 while living with a household member who tested positive for COVID-19 or had a close contact with the viral infection in the context of their work, and never had any COVID-19 related symptoms (presumed COVID negative control group).

OR

• Individuals who don't have any COVID-19 related symptoms actually, have never had tested positive, and have had at least one negative PCR, serology or antibody/antigen COVID-19 test (presumed COVID negative control group).

OR

• Individuals with an undiagnosed viral infection in the last 60 months at day of recruitment and have persistent symptoms (or not) after the participant has recovered from a viral infection.

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)