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

NCT04736732 | Recruiting

• 1 other identifier: 2021-1092
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

Brief 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 \[hospitalized\]). 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.

Conditions

Covid19; Long COVID

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (14)

• 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

  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

  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

Study Arms (6)

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

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

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

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

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

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

Interventions

Medical follow-up OTHER

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

Also known as: Sample collection

COVID-19 Recovered group; COVID-19 negative group; Long COVID group; Long COVID-hospitalized group; Recovered post-viral group; Symptomatic post-viral group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• 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).
• 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).
• 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).
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emilia Falcone, MD: lead

Study Sites (1)

Institut de Recherches Cliniques de Montreal

Montreal, Quebec, H2W 1R7, Canada

RECRUITING

Related Publications (2)

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

  RESULT

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

  RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Saliva, nasopharyngeal swabs, blood/plasma/serum, peripheral blood mononuclear cells, urine, stool, sebum

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Emilia Liana Falcone, M.D., Ph.D.

  IRCM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, IRCM Post-COVID-19 Research Clinic

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 3, 2021
• Study Start: February 1, 2021
• Primary Completion (Estimated): May 4, 2027
• Study Completion (Estimated): November 4, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• 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.
• Access Criteria: Recognized researcher collaborating with PI.

Locations

CA (1)