NCT04736732

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

IRCM Post-COVID-19 (IPCO) Research Clinic: a Multidisciplinary Approach to Evaluate Short and Long-term Complications of COVID-19

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 650 (estimated)
• Sponsor: Emilia Falcone, MD · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

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)

Conditions

• Covid19
• Long COVID

Interventions

Type	Name	Description
OTHER	Medical follow-up	Patients will be followed for medical evaluation and for biobanking of data and biological samples.

Timeline

• Start date: 2021-02-01
• Primary completion: 2027-05-04
• Completion: 2027-11-04
• First posted: 2021-02-03
• Last updated: 2026-04-17

Locations

1 site across 1 country: Canada