Clinical trial NCT04736732: Institut de Recherche Cliniques de Montreal (IRCM) Post-COVID-19 (IPCO) Research Clinic
Official title: IRCM Post-COVID-19 (IPCO) Research Clinic: a Multidisciplinary Approach to Evaluate Short and Long-term Complications of COVID-19
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Covid19
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
Lead sponsor: Institut de Recherches Cliniques de Montreal
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 570
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Adults who have had a positive diagnosis of COVID-19.
* Adults who have tested negative for COVID-19 (control group)

Brief 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)

Detailed description: 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)

Primary outcomes:
measure: Evaluate the short- and long-term end-organ complications post-COVID-19 in relation to the severity of the acute COVID-19 infection.
timeFrame: 2 years
measure: Establish a post-COVID-19 biobank.
timeFrame: 2 years
Secondary outcomes:
measure: 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).
timeFrame: 2 year
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Institut de Recherches Cliniques de Montreal
state: Quebec
Study officials:
affiliation: IRCM
name: Emilia Liana Falcone, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: