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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorEmilia Falcone, MD

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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 )

Disqualifiers

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 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Medical follow-up

    Other intervention

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

Treatment groups

650 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Long COVID group1 intervention
Group B: Long COVID-hospitalized group1 intervention
Group C: COVID-19 Recovered group1 intervention
Group D: COVID-19 negative group1 intervention
Group E: Recovered post-viral group1 intervention
Group F: Symptomatic post-viral group1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
5 years

Secondary outcomes

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.

Time frame
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

Time frame
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).

Time frame
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

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emilia Falcone, MD

Lead sponsor

Institut de Recherches Cliniques de Montreal

Sponsor institution