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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva, nasopharyngeal swabs, blood/plasma/serum, peripheral blood mononuclear cells, urine, stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 570}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2027-11-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2021-02-01', 'studyFirstSubmitQcDate': '2021-02-02', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the short- and long-term end-organ complications post-COVID-19 in relation to the severity of the acute COVID-19 infection.', 'timeFrame': '2 years'}, {'measure': 'Establish a post-COVID-19 biobank.', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': '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).', 'timeFrame': '2 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-COVID-19 syndrome', 'COVID-19-related long-term complications', 'COVID-19 long haulers', 'Post-COVID-19 condition', 'Post-acute sequelae of COVID-19', 'Long COVID'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'Sample Size: n=570\n\nAccrual Ceiling: n=627\n\nStudy Population: Patients age 18 to 100 years\n\nThe 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.\n\nStudy 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.\n\nParticipant Cohorts:\n\n1. Individuals who had previous asymptomatic or mild COVID-19 (mild=never required supplemental oxygen during the acute phase of the infection)\n2. 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)\n3. 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\n4. 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)', 'detailedDescription': 'Primary Objectives:\n\n1. Evaluate the short- and long-term end-organ complications post-COVID-19 in relation to the severity of the acute COVID-19 infection.\n2. Establish a post-COVID-19 biobank.\n\nSecondary Objectives:\n\n1\\) Develop a model that may predict the development of end-organ complications.\n\nPrimary Endpoint:\n\nThe development of any end-organ complication that can plausibly be related to COVID-19.\n\nSecondary Endpoints:\n\n1. Detection of any new abnormality on echocardiogram \\>4 weeks after COVID-19 symptom-onset or diagnosis.\n\n 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.\n2. 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).\n3. Any change in pre-COVID-19 weight, waist circumference or body mass composition.\n4. 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.\n5. A positive fecal calprotectin or lactoferrin measurement occurring \\>4 weeks after COVID-19 symptom-onset or diagnosis.\n6. 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.\n7. 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.\n\nMethodology:\n\nIndividuals 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.\n\nMedical visits include:\n\n* Clinical assessment\n* Epidemiological questionnaire\n* Well-being questionnaire\n* Food frequency questionnaire\n* Physical exam (if indicated)\n* Vital signs\n* Measurement of waist circumference\n* Weight and height measurement\n* Impedance / evaluation of body mass composition\n* Actimeter reading\n* Pulmonary function test\n* Echocardiography\n* Electrocardiogram\n* Urine collection\n* Blood draw\n* Saliva collection\n* Stool collection (optional)\n* Nasopharyngeal swab (optional)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Adults who have had a positive diagnosis of COVID-19.\n* Adults who have tested negative for COVID-19 (control group)', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Any gender, ≥ 18 years old\n* Current resident of Quebec\n* Speaks English or French\n* Have a personal email (to which to send reminders and questionnaire by email )\n\nAND\n\n1 of the following criteria:\n\n* At least one COVID-19 positive PCR test, serology or antibody/antigen test in the last 24 months at day of recruitment.\n* 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.\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* Any participant not deemed appropriate for enrollment according to the PI\n* Known pregnancy (female will not be automatically screened for pregnancy upon enrollment unless there is a possibility that they might be pregnant)"}, 'identificationModule': {'nctId': 'NCT04736732', 'acronym': 'IPCO', 'briefTitle': 'Institut de Recherche Cliniques de Montreal (IRCM) Post-COVID-19 (IPCO) Research Clinic', 'organization': {'class': 'OTHER', 'fullName': 'Institut de Recherches Cliniques de Montreal'}, 'officialTitle': 'IRCM Post-COVID-19 (IPCO) Research Clinic: a Multidisciplinary Approach to Evaluate Short and Long-term Complications of COVID-19', 'orgStudyIdInfo': {'id': '2021-1092'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 positive patients', 'description': '1. Patients who had previous asymptomatic or mild COVID-19 (mild=never required supplemental oxygen during the acute phase of the infection)\n2. 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\n3. 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', 'interventionNames': ['Other: Medical follow-up']}, {'label': 'COVID-19 negative patients', 'description': '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)', 'interventionNames': ['Other: Medical follow-up']}], 'interventions': [{'name': 'Medical follow-up', 'type': 'OTHER', 'otherNames': ['Sample collection'], 'description': 'Patients will be followed for medical evaluation and for biobanking of data and biological samples.', 'armGroupLabels': ['COVID-19 negative patients', 'COVID-19 positive patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2W 1R7', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Charlotte Du Sablon, M.Sc.', 'role': 'CONTACT', 'email': 'Charlotte.Dusablon@ircm.qc.ca', 'phone': '514-987-5581'}, {'name': 'Emilia Liana Falcone, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut de Recherches Cliniques de Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Emilia Liana Falcone, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'Emilia.falcone@ircm.qc.ca', 'phone': '514-987-5610'}, {'name': 'Charlotte Du Sablon, M.Sc.', 'role': 'CONTACT', 'email': 'Charlotte.Dusablon@ircm.qc.ca', 'phone': '514-987-5581'}], 'overallOfficials': [{'name': 'Emilia Liana Falcone, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCM'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Future collaborations will be possible with data from the biobank. All data will be anonymous and a committee will evaluate requests for access to the biobank. The principal investigator is responsible for the biobank.', 'accessCriteria': 'Recognized researcher collaborating with PI.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emilia Falcone, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, IRCM Post-COVID-19 Research Clinic', 'investigatorFullName': 'Emilia Falcone, MD', 'investigatorAffiliation': 'Institut de Recherches Cliniques de Montreal'}}}}