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

Covid19 Clinical Trial

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

Status Recruiting

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)

Clinical Trial 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) ;

Related Conditions & MeSH terms

• COVID-19
• Covid19

• NCT number: NCT04736732
• Study type: Observational
• 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
• Status: Recruiting
• Start date: January 1, 2021
• Completion date: November 4, 2027