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

Covid19 Clinical Trial

— IPCO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04736732
• Other study ID #: 2021-1092
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: November 4, 2027

Study information

• Verified date: April 2024
• Source: Institut de Recherches Cliniques de Montreal
• Contact: Emilia Liana Falcone, M.D., Ph.D.
• Phone: 514-987-5610
• Email: Emilia.falcone[@]ircm.qc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Sample Size: n=570

Accrual Ceiling: n=627

Study Population: Patients age 18 to 100 years

The study duration includes 51 months to recruit patients and 24 months of total follow-up time counted from the first day of COVID-19 symptoms or date of confirmed COVID-19 diagnosis.

Study Design: This is a prospective, observational cohort study to evaluate the short- and long-term end-organ complications of COVID-19 and to establish a COVID-19 biobank.

Participant Cohorts:

1. Individuals who had previous asymptomatic or mild COVID-19 (mild=never required supplemental oxygen during the acute phase of the infection)

2. Individuals who had previous moderate or severe COVID-19 (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)

3. Individuals 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

4. Individuals who have not had COVID-19 (i.e. individuals who tested negative for COVID-19 and who never had symptoms consistent with COVID-19)

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:

1) 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.

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.

2. An increase in liver enzymes > 2 times 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).

3. Any change in pre-COVID-19 weight, waist circumference or body mass composition.

4. Any change in glycated hemoglobin (HgA1C), lipid profile, thyroid stimulating hormone (TSH), T4 from pre-COVID-19 baseline that begins or persists >4 weeks after COVID-19 symptom-onset or diagnosis.

5. A positive fecal calprotectin or lactoferrin measurement occurring >4 weeks after COVID-19 symptom-onset or diagnosis.

6. 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.

7. Any change in dietary habits (nutritional quantity and quality) as measured by the Food Frequency Questionnaire, in physical activity as measured by actimeter reading, and/or well-being as measured by our Well-Being Questionnaire.

Methodology:

Individuals diagnosed with COVID-19 (for more than 28 days) will have up to 5 medical visits (depending on the time since diagnosis) over the course of 24 months from the date of COVID-19 symptom onset or diagnosis. COVID-19 negative individuals will have up to 3 medical visits. The data will be collected for clinical monitoring and biobanking purposes.

Medical visits include:

• Clinical assessment

• Epidemiological questionnaire

• Well-being questionnaire

• Food frequency 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

• Stool collection (optional)

• Nasopharyngeal swab (optional)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 570
• Est. completion date: November 4, 2027
• Est. primary completion date: May 4, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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:

• At least one COVID-19 positive PCR test, serology or antibody/antigen test in the last 24 months at day of recruitment.

• In the absence of a positive COVID-19 test, the patient had symptoms consistent with COVID-19 while living with a person who had a confirmed positive PCR/serology COVID-19 test.

• Individual who tested negative for COVID-19 while living with a household member who tested positive for COVID-19 (control group), and never had any COVID-19 related symptoms.

• Individual who doesn't have any COVID-19 related symptoms actually, has never had tested positive, and has had at least one negative PCR test.

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)

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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

Locations

Country	Name	City	State
Canada	Institut de Recherches Cliniques de Montreal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Emilia Falcone, MD

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the short- and long-term end-organ complications post-COVID-19 in relation to the severity of the acute COVID-19 infection.		2 years
Primary	Establish a post-COVID-19 biobank.		2 years
Secondary	The development of any end-organ complication that can plausibly be related to COVID-19. We will evaluate the following end-organ systems: neurological, cardiovascular, pulmonary, renal, endocrine and metabolic, gastro-intestinal (GI).		2 year