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:
- Individuals who had previous asymptomatic or mild COVID-19 (mild=never required supplemental oxygen during the acute phase of the infection)
- 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)
- 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
- 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)
Description
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.
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)
Eligibility
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:
- At least one COVID-19 positive PCR test, serology or antibody/antigen test in the last 24 months at day of recruitment.
- In the absence of a positive COVID-19 test, the patient had symptoms consistent with COVID-19 while living with a person who had a confirmed positive PCR/serology COVID-19 test.
- Individual who tested negative for COVID-19 while living with a household member who tested positive for COVID-19 (control group), and never had any COVID-19 related symptoms.
- Individual who doesn't have any COVID-19 related symptoms actually, has never had tested positive, and has had at least one negative PCR test.
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)