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

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: Recruiting
• Conditions: Covid19; Long COVID
• Intervention / Treatment: Other: Medical follow-up

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: Observational
• Enrollment (Estimated): 650

Contacts and Locations

• Study Contact: Name: Emilia Liana Falcone, M.D., Ph.D.; Phone Number: 514-987-5610; Email: Emilia.falcone@ircm.qc.ca
• Study Contact Backup: Name: Charlotte Du Sablon, M.Sc.; Phone Number: 514-987-5581; Email: Charlotte.Dusablon@ircm.qc.ca

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: Charlotte Du Sablon, M.Sc.; Phone Number: 514-987-5581; Email: Charlotte.Dusablon@ircm.qc.ca

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

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.	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.	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.	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.	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.	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).	The development of any gastro-intestinal complication that can be plausibly related to COVID-19 will be evaluated.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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).	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	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	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	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	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	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	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)	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	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	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.	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)	Scored 0-6: 0: I cannot do this; My capacity will be severely reduced for at least three days; I can do little else on the same day and for one to two days afterwards; I can do little else on the same day; I must limit other activities on the same day; This rarely affects other activities; Unproblematic - does not affect other activities	5 years

Collaborators and Investigators

• Sponsor: Emilia Falcone, MD
• Investigators: Principal Investigator: Emilia Liana Falcone, M.D., Ph.D., IRCM

Publications and helpful links

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

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): May 4, 2027
• Study Completion (Estimated): November 4, 2027

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Long COVID; Post-COVID-19 syndrome; Post-COVID-19 condition; COVID-19-related long-term complications; COVID-19 long haulers; Post-acute sequelae of COVID-19
• Additional Relevant MeSH Terms: Post-Infectious Disorders; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Pathological Conditions, Signs and Symptoms; COVID-19; Post-Acute COVID-19 Syndrome; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling
• Other Study ID 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