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

April 13, 2026 updated by: Emilia Falcone, MD

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2W 1R7
        • Recruiting
        • Institut de recherches cliniques de Montreal
        • Principal Investigator:
          • Emilia Liana Falcone, M.D., Ph.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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
  • Adults with a history of acute flu-like illness

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Long COVID group
Patients 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)
Other: Medical follow-up
Patients will be followed for medical evaluation and for biobanking of data and biological samples.
Other Names:
  • Sample collection
Long COVID-hospitalized group
Patients 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
Other: Medical follow-up
Patients will be followed for medical evaluation and for biobanking of data and biological samples.
Other Names:
  • Sample collection
COVID-19 Recovered group
Patients 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
Other: Medical follow-up
Patients will be followed for medical evaluation and for biobanking of data and biological samples.
Other Names:
  • Sample collection
COVID-19 negative group
Presumed 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.)
Other: Medical follow-up
Patients will be followed for medical evaluation and for biobanking of data and biological samples.
Other Names:
  • Sample collection
Recovered post-viral group
Patients 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
Other: Medical follow-up
Patients will be followed for medical evaluation and for biobanking of data and biological samples.
Other Names:
  • Sample collection
Symptomatic post-viral group
Patients 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.
Other: Medical follow-up
Patients will be followed for medical evaluation and for biobanking of data and biological samples.
Other Names:
  • Sample collection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 development of any cardiovascular complication that can be plausibly related to COVID-19 will be evaluated.
5 years
The development of any end-organ complication that can be plausibly related to COVID-19. The following end-organ systems will be evaluated: pulmonary.
Time Frame: 5 years
The development of any pulmonary complication that can be plausibly related to COVID-19 will be evaluated.
5 years
The development of any end-organ complication that can be plausibly related to COVID-19. The following end-organ systems will be evaluated: renal.
Time Frame: 5 years
The development of any renal complication that can be plausibly related to COVID-19 will be evaluated.
5 years
The development of any end-organ complication that can be plausibly related to COVID-19. The following end-organ systems will be evaluated: endocrine.
Time Frame: 5 years
The development of any endocrine complication that can be plausibly related to COVID-19 will be evaluated.
5 years
The development of any end-organ complication that can be plausibly related to COVID-19. The following end-organ systems will be evaluated: metabolic.
Time Frame: 5 years
The development of any metabolic complication that can be plausibly related to COVID-19 will be evaluated.
5 years
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).
Time Frame: 5 years
The development of any gastro-intestinal complication that can be plausibly related to COVID-19 will be evaluated.
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Detection of any new abnormality on echocardiogram >4 weeks after COVID-19 symptom-onset or diagnosis.
Time Frame: 5 years
Detection of any new abnormality on echocardiogram >4 weeks after COVID-19 symptom-onset or diagnosis.
5 years
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
Time Frame: 5 years
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
5 years
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).
Time Frame: 5 years
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).
5 years
Any change in pre-COVID-19 weight, waist circumference or body mass composition
Time Frame: 5 years
Any change in pre-COVID-19 weight, waist circumference or body mass composition
5 years
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
Time Frame: 5 years
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
5 years
A positive fecal calprotectin or lactoferrin measurement occurring >4 weeks after COVID-19 symptom-onset or diagnosis
Time Frame: 5 years
A positive fecal calprotectin or lactoferrin measurement occurring >4 weeks after COVID-19 symptom-onset or diagnosis
5 years
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
Time Frame: 5 years
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
5 years
Any change in physical activity and/or exercise tolerance as measured by actimeter reading or 6-minute walk test (6MWT) with ambulatory oximetry
Time Frame: 5 years
Any change in physical activity and/or exercise tolerance as measured by actimeter reading or 6-minute walk test (6MWT) with ambulatory oximetry
5 years
Any change in well-being as measured by our WHO Well-Being Questionnaire
Time Frame: 5 years

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.
5 years
Any change in functional status as measured with the Post COVID-19 Functional Status Scale (PCFS)
Time Frame: 5 years
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
5 years
Any change in quality of life, as measured by the European Quality of Life 5 Dimensions (EuroQol-5D) tool
Time Frame: 5 years

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.
5 years
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
Time Frame: 5 years

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
5 years
Any detection of new (i.e., not known to be present prior to COVID-19 infection) cardiac dysautonomia using the 10-minute standing test.
Time Frame: 5 years
Evaluation of any new cardiac dysautonomia using the 10-minute standing test.
5 years
Any detection or exacerbation of post-exertional malaise (PEM)/post-exertional symptom exacerbation (PESE) using the Questionnaire on functionnal capacity (FUNCAP27)
Time Frame: 5 years

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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emilia Falcone, MD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emilia Liana Falcone, M.D., Ph.D., IRCM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • https://doi.org/10.21203/rs.3.rs-8876163/v1
  • https://doi.org/10.21203/rs.3.rs-8876425/v1

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 4, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 4, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-1092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

All material (original or derived) and data will be stored for as long as the biobank has a scientific interest for the community and the director can ensure its management.

IPD Sharing Access Criteria

Recognized researcher collaborating with PI.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on Medical follow-up

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings