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

NCT ID: NCT04736732

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 570 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2027-11-04

Brief 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)

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:

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)

Conditions

Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COVID-19 positive patients

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

2. Patients 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. 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

Medical follow-up

Intervention Type: OTHER

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

COVID-19 negative patients

Patients who have not had COVID-19 (i.e., patients who tested negative for COVID-19 and who never had symptoms consistent with COVID-19)

Medical follow-up

Intervention Type: OTHER

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

Interventions

Medical follow-up

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

Intervention Type: OTHER

Other Intervention Names

Sample collection

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:

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emilia Falcone, MD

OTHER

Sponsor Role: lead

Responsible Party

Emilia Falcone, MD

Director, IRCM Post-COVID-19 Research Clinic

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

IRCM

Locations

Institut de Recherches Cliniques de Montreal

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

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

Role: CONTACT

Emilia.falcone@ircm.qc.ca

514-987-5610

Charlotte Du Sablon, M.Sc.

Role: CONTACT

Charlotte.Dusablon@ircm.qc.ca

514-987-5581

Facility Contacts

Charlotte Du Sablon, M.Sc.

Role: primary

Charlotte.Dusablon@ircm.qc.ca

514-987-5581

Other Identifiers

2021-1092

Identifier Type: -

Identifier Source: org_study_id