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Covid19IPCONCT04736732

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

An observational study of Covid19 and Long COVID, run by Emilia Falcone, MD at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

While many COVID19 studies are focusing on the immediate biological impact of SARS-CoV2 infection, this multidisciplinary research clinic will inform the global community on its recovery phase across patient cohorts with different degrees of disease severity (asymptomatic, mild [non-hospitalized], moderate/severe… Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Covid19, Long COVID
What is being tested?
Medical follow-up
How many people
650 participants
Where
1 siteCanada
Study dates
1 Feb 2021to 4 Nov 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: * Adults who have had a positive diagnosis of COVID-19. * Adults who have tested negative for COVID-19 * Adults with a history of acute flu-like illness

Who may be able to join

  • 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:
Show all 13Show fewer
  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Emilia Liana Falcone, M.D., Ph.D. contact

514-987-5610

Emilia.falcone@ircm.qc.ca

Charlotte Du Sablon, M.Sc. contact

514-987-5581

Charlotte.Dusablon@ircm.qc.ca

Canada1 site, 1 recruiting

  • Institut de Recherches Cliniques de Montreal

    Montreal, Quebec, H2W 1R7

    Charlotte Du Sablon, M.Sc., 514-987-5581, Charlotte.Dusablon@ircm.qc.ca

    Emilia Liana Falcone, M.D., Ph.D.

    Recruiting

Other trials in Canada

About this study

Official title: IRCM Post-COVID-19 (IPCO) Research Clinic: a Multidisciplinary Approach to Evaluate Short and Long-term Complications of COVID-19

While many COVID19 studies are focusing on the immediate biological impact of SARS-CoV2 infection, this multidisciplinary research clinic will inform the global community on its recovery phase across patient cohorts with different degrees of disease severity (asymptomatic, mild [non-hospitalized], moderate/severe [hospitalized]). The primary objectives are to: 1) evaluate the short- and long-term end-organ complications post-COVID-19 in relation to the severity of the acute COVID-19 infection and 2) establish a post-COVID-19 biobank. The secondary objective is to develop a model that can predict end-organ complications using epidemiological and clinical data. To complete the objectives, the study will follow 6 patient cohorts: Patients who had previous asymptomatic or mild COVID-19 (no need for oxygen), patients who had previous moderate/severe COVID-19 (patients who had an oxygen requirement; moderate=oxygen by nasal cannula; severe=oxygen by high flow nasal cannula, non-invasive positive pressure ventilation or intubation), patients who had COVID-19 but did not develop the post-COVID-19 condition, patients who have never had COVID-19, patients who had flu-like symptoms but did not have signs or symptoms related to the infection lasting beyond 4 weeks from the date of symptom-onset, and patients with flu-like symptoms and have signs or symptoms related to the infection lasting beyond 4 weeks from the date of symptom-onset. Patients will be recruited into these cohorts using a strategy that targets the following populations: patients that were hospitalized in centers across Montreal, patients already followed at the IRCM (non-COVID-19) clinic, essential workers, and members of the same household as patients already enrolled in the IPCO clinic research protocol. The IPCO clinic research protocol is the first in the province of Quebec to systematically follow patients post-COVID-19 for short- and long-term complications including end-organ damage while building an extensive biobank that can support future mechanistic research projects.

Read the 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:

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.
  2. 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.
  3. 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).
  4. Any change in pre-COVID-19 weight, waist circumference or body mass composition.
  5. 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.
  6. A positive fecal calprotectin or lactoferrin measurement occurring >4 weeks after COVID-19 symptom-onset or diagnosis.
  7. 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.
  8. Any change in physical activity and/or exercise tolerance as measured by actimeter reading or 6-minute walk test (6MWT) with ambulatory oximetry
  9. Any change in well-being as measured by our WHO Well-Being Questionnaire
  10. Any change in functional status as measured with the Post COVID-19 Functional Status Scale (PCFS)
  11. Any change in quality of life, as measured by the European Quality of Life 5 Dimensions (EQ-5D-5L) tool
  12. 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
  13. 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)
Conditions
Covid19, Long COVID
Being tested
Medical follow-up
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
Medical subject headings
COVID-19, Post-Acute COVID-19 Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medical follow-upOther

    Also called Sample collection

    Patients will be followed for medical evaluation and for biobanking of data and biological samples.

Study groups in NCT04736732
Study groupRoleWhat they receive
Long COVID groupPatients who had previous asymptomatic or mild COVID-19 and have signs or symptoms related to COVID-19 lasting beyond 4 weeks from the date of COVID-19 symptom-onset or diagnosis (mild=never required supplemental oxygen during the acute phase of the infection)
Receives: Other: Medical follow-up
Long COVID-hospitalized groupPatients who had previous moderate or severe COVID-19 and have signs or symptoms related to COVID-19 lasting beyond 4 weeks from the date of COVID-19 symptom-onset or diagnosis (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
Receives: Other: Medical follow-up
COVID-19 Recovered groupPatients 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
Receives: Other: Medical follow-up
COVID-19 negative groupPresumed COVID negative patients (i.e., either 1) patients who never had symptoms consistent with COVID-19 AND never tested positive for COVID-19 by molecular or rapid test.)
Receives: Other: Medical follow-up
Recovered post-viral groupPatients with a history of acute flu-like illness who do not continue to experience persistent signs or symptoms attributable to the infection for ≥4 weeks from symptom onset.. Eligible patients may have laboratory-confirmed viral infection other than COVID-19 or a suspected viral infection without laboratory confirmation. Patients with confirmed COVID-19 are excluded
Receives: Other: Medical follow-up
Symptomatic post-viral groupPatients with a history of acute flu-like illness who continue to experience persistent signs or symptoms attributable to the infection for ≥4 weeks from symptom onset. Eligible patients may have laboratory-confirmed viral infection other than COVID-19 or a suspected viral infection without laboratory confirmation. Patients with confirmed COVID-19 are excluded.
Receives: Other: Medical follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The development of any end-organ complication that can be plausibly related to COVID-19. The following end-organ systems will be evaluated: cardiovascular.

    The development of any cardiovascular complication that can be plausibly related to COVID-19 will be evaluated.

    Measured: 5 years

  2. The development of any end-organ complication that can be plausibly related to COVID-19. The following end-organ systems will be evaluated: pulmonary.

    The development of any pulmonary complication that can be plausibly related to COVID-19 will be evaluated.

    Measured: 5 years

  3. The development of any end-organ complication that can be plausibly related to COVID-19. The following end-organ systems will be evaluated: renal.

    The development of any renal complication that can be plausibly related to COVID-19 will be evaluated.

    Measured: 5 years

  4. The development of any end-organ complication that can be plausibly related to COVID-19. The following end-organ systems will be evaluated: endocrine.

    The development of any endocrine complication that can be plausibly related to COVID-19 will be evaluated.

    Measured: 5 years

  5. The development of any end-organ complication that can be plausibly related to COVID-19. The following end-organ systems will be evaluated: metabolic.

    The development of any metabolic complication that can be plausibly related to COVID-19 will be evaluated.

    Measured: 5 years

  6. The development of any end-organ complication that can be plausibly related to COVID-19. The following end-organ systems will be evaluated: gastro-intestinal (GI).

    The development of any gastro-intestinal complication that can be plausibly related to COVID-19 will be evaluated.

    Measured: 5 years

Secondary outcomes (14)

  1. Detection of any new abnormality on echocardiogram >4 weeks after COVID-19 symptom-onset or diagnosis.

    Detection of any new abnormality on echocardiogram >4 weeks after COVID-19 symptom-onset or diagnosis.

    Measured: 5 years

  2. 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

    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

    Measured: 5 years

  3. 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).

    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).

    Measured: 5 years

  4. Any change in pre-COVID-19 weight, waist circumference or body mass composition

    Any change in pre-COVID-19 weight, waist circumference or body mass composition

    Measured: 5 years

  5. 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

    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

    Measured: 5 years

  6. A positive fecal calprotectin or lactoferrin measurement occurring >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

    Measured: 5 years

  7. 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 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

    Measured: 5 years

  8. 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 physical activity and/or exercise tolerance as measured by actimeter reading or 6-minute walk test (6MWT) with ambulatory oximetry

    Measured: 5 years

  9. Any change in well-being as measured by our WHO Well-Being Questionnaire

    Raw Score: Sum of 5 items (ranging from 0 = "At no time" to 5 = "All of the time").

    Total Range: 0 to 25. Percentage Score: (raw score) X 4. Represents a scale of 0-100.

    Interpretation:

    0-25: Low well-being, potential depression (further evaluation recommended). 26-50: Suboptimal well-being. 51-100: Good mental well-being.

    Measured: 5 years

  10. Any change in functional status as measured with the Post COVID-19 Functional Status Scale (PCFS)

    No limitations = PCFS Score 0 Negligible limitations = PCFS Score 1 Slight limitations = PCFS Score 2 Moderate limitations = PCFS Score 3 Severe limitations = PCFS Score 4

    Measured: 5 years

  11. Any change in quality of life, as measured by the European Quality of Life 5 Dimensions (EuroQol-5D) tool

    A unique health state is defined by combining one level from each of the five dimensions. Each of the five dimensions comprising theEQ-5D-5L descriptive system is divided into five levels of perceived problems:

    LEVEL 1: no problem LEVEL 2: slight problems LEVEL 3: moderate problems LEVEL 4: severe problems LEVEL 5: unable to/extreme problems A unique health state is defined by combining one level from each of the five dimensions. A total of 3125 possible health states is defined in this way. Each state is referred to by a 5-digit code. For example, working clockwise from the top of the diagram, state 12345 indicates no problems with mobility, slight problems with washing or dressing, moderate problems with doing usual activities, severe pain or discomfort and extreme anxiety or depression, while state 11111 indicates no problems on any of the five dimensions.

    Measured: 5 years

  12. 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 questionnaire

    Scoring Step 1 Items 1-5: A frequency and severity score of 2, 2 on any items 1-5 is indicative of PEM.

    Range 0-4

    Scoring Step 2 Items 7, 8: Either item 7 or 8 must have an answer of yes to indicate an ME and/or CFS dx.

    Item 9: A response of >14 h is needed to indicate an ME and/or CFS dx. Items 6, 10: Neither item indicates an ME and/or CFS diagnosis, but provides a description of patient PEM for clinical evaluations

    Measured: 5 years

  13. Any detection of new (i.e., not known to be present prior to COVID-19 infection) cardiac dysautonomia using the 10-minute standing test.

    Evaluation of any new cardiac dysautonomia using the 10-minute standing test.

    Measured: 5 years

  14. Any detection or exacerbation of post-exertional malaise (PEM)/post-exertional symptom exacerbation (PESE) using the Questionnaire on functionnal capacity (FUNCAP27)

    Scored 0-6:

    0: I cannot do this

    1. My capacity will be severely reduced for at least three days
    2. I can do little else on the same day and for one to two days afterwards
    3. I can do little else on the same day
    4. I must limit other activities on the same day
    5. This rarely affects other activities
    6. Unproblematic - does not affect other activities

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2021
  2. Study start1 Feb 2021
  3. Primary completion4 May 2027 (estimated)
  4. Study completion4 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
650 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04736732
Sponsor's protocol ID
2021-1092
Acronym
IPCO
Status last verified
Apr 2026
First submitted
1 Feb 2021
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Future collaborations will be possible with data from the biobank. All data will be anonymous and a committee will evaluate requests for access to the biobank. The principal investigator is responsible for the biobank.

Publications

  • https://doi.org/10.21203/rs.3.rs-8876163/v1

  • https://doi.org/10.21203/rs.3.rs-8876425/v1

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and Long COVID, run by Emilia Falcone, MD at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emilia Liana Falcone, M.D., Ph.D. (514-987-5610, Emilia.falcone@ircm.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The development of any end-organ complication that can be plausibly related to COVID-19. The following end-organ systems will be evaluated: cardiovascular. (time frame: 5 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04736732, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

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