Recruiting

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

Sponsor:

Emilia Falcone, MD

Code:

NCT04736732

Conditions

Covid19

Long COVID

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Medical follow-up

Study Details

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

Study ID

NCT04736732

Start date

Feb 1, 2021

Status verified date

Apr, 2026

Completion date

Nov 4, 2027

Anticipated

Primary completion date

May 4, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

650 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

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

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

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.)

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

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.

Interventions

Medical follow-up

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

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 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 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 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 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 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 ]

Central Contacts and Locations

Central contacts

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

514-987-5610 Emilia.falcone@ircm.qc.ca

Charlotte Du Sablon, M.Sc.

514-987-5581 Charlotte.Dusablon@ircm.qc.ca

Locations

Institut de Recherches Cliniques de Montreal

Recruiting

Montreal, Quebec, Canada, H2W 1R7

Contacts

Charlotte Du Sablon, M.Sc.

514-987-5581 Charlotte.Dusablon@ircm.qc.ca

Principal Investigator:

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

More Information

Sponsor

Emilia Falcone, MD

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emilia Falcone, MD on 2026-04-17.