Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT04736732
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2021-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Institut de Recherche Cliniques de Montreal (IRCM) Post-COVID-19 (IPCO) Research Clinic
Sponsor:
Emilia Falcone, MD
Organization:
Study Overview
Official Title:
IRCM Post-COVID-19 (IPCO) Research Clinic: a Multidisciplinary Approach to Evaluate Short and Long-term Complications of COVID-19
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IPCO
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)
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)
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)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: