institut de recherche cliniques de montreal (ircm) post-covid-19 (ipco) research clinic

Conditions: Covid19

Summary: 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)

Eligibility criteria:
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)

Keywords: post-covid-19 syndrome covid-19-related long-term complications covid-19 long haulers post-covid-19 condition post-acute sequelae of covid-19 long covid