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

Official title

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

Overview

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)

Interventions

• Other Medical follow-up
  Patients will be followed for medical evaluation and for biobanking of data and biological samples.

Primary outcome measures

• 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]

Secondary outcome measures (12)

• Detection of any new abnormality on echocardiogram >4 weeks after COVID-19 symptom-onset or diagnosis. [Time frame: 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 [Time frame: 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). [Time frame: 5 years]
• Any change in pre-COVID-19 weight, waist circumference or body mass composition [Time frame: 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 [Time frame: 5 years]
• A positive fecal calprotectin or lactoferrin measurement occurring >4 weeks after COVID-19 symptom-onset or diagnosis [Time frame: 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 [Time frame: 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 [Time frame: 5 years]
• Any change in well-being as measured by our WHO Well-Being Questionnaire [Time frame: 5 years]
• Any change in functional status as measured with the Post COVID-19 Functional Status Scale (PCFS) [Time frame: 5 years]
• Any change in quality of life, as measured by the European Quality of Life 5 Dimensions (EuroQol-5D) tool [Time frame: 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 [Time frame: 5 years]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Canada · 1 center

• Institut de Recherches Cliniques de Montreal — Montreal

Publications

• https://doi.org/10.21203/rs.3.rs-8876163/v1
• https://doi.org/10.21203/rs.3.rs-8876425/v1

Identifiers

NCT: NCT04736732 · 2021-1092

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗