Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-01-13 @ 5:14 PM
Study NCT ID:
NCT05002205
Status:
UNKNOWN
Last Update Posted:
2021-08-18
First Post:
2021-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Effects of COVID-19: a Comparative Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-12', 'studyFirstSubmitDate': '2021-07-16', 'studyFirstSubmitQcDate': '2021-08-11', 'lastUpdatePostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue severity 6 months after diagnosis of COVID-19.', 'timeFrame': '6 months post-COVID', 'description': "Data for this endpoint are collected with a questionnaire during the first study visit at 6 months. The severity of fatigue will be assessed using the Fatigue Severity Scale (FSS). This is a 9-item scale which measures the severity of fatigue and how it affects a person's activities and lifestyle.\n\nThe score ranges from 7 to 63, with higher values indicating more fatigue."}], 'secondaryOutcomes': [{'measure': 'Incidence of post-COVID symptoms', 'timeFrame': '6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID', 'description': 'Incidence of each individual symptoms at 6 months, 9 months, 1 year, 1.5 years and 2 years including cough, difficulty breathing, tightness on the chest, pain in the lungs, throatache, muscle ache, muscle weakness, joint pain, pain between the shoulder blades, headache, dizziness, confusion, concentration loss/lack of focus, concentration problems on short and long term, feeling absent, difficulties finding words/afasia, palpitations, hot flushes, sleeping problems, abdominal pain, blurred vision, nerve pains, sensory disorders, mood swings, anxiety, depressive feeling (Source: questionnaire during study visits and remote surveys)'}, {'measure': "Participants' quality of life", 'timeFrame': '6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID', 'description': 'Euroqol EQ-5D-5L: The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems, where higher scores indicate a better outcome (Source: questionnaire during study visits and remote surveys)'}, {'measure': 'Lung function (FEV1, FVC)', 'timeFrame': '6 months and 1 year post-COVID', 'description': '(Source: spirometry during study visits at 6 months and 1 year)'}, {'measure': 'The degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4 (mMRC scale)', 'timeFrame': '6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID', 'description': '0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing'}, {'measure': 'Gustatation', 'timeFrame': '6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID', 'description': 'scale from 1 to 10; higher scores indicate more problems with gustation. (Source: questionnaires during study visits and remote surveys)'}, {'measure': 'Olfaction', 'timeFrame': '6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID', 'description': 'scale from 1 to 10; higher scores indicate more problems with olfaction. (Source: questionnaires during study visits and remote surveys)'}, {'measure': 'Incidence of diagnoses of COPD', 'timeFrame': '6 months and 1 year post-COVID', 'description': 'Source: spirometry during study visits'}, {'measure': 'Exercice capacity and endurance', 'timeFrame': '6 months and 1 year post-COVID', 'description': 'Source: 1 minute sit to stand test during study visits'}, {'measure': 'Incidence of cardiovascular events including AMI, lung embolism of stroke', 'timeFrame': '6 months and 1 year post-COVID', 'description': 'Questionnaire during study visits'}, {'measure': 'Number of Unplanned hospital admissions of at least 24 hours', 'timeFrame': 'within 2 years post-COVID', 'description': 'Source: questionnaire during study visits and remote surveys'}, {'measure': 'Number of Visits to healthcare professionals', 'timeFrame': 'within 2 years post-COVID', 'description': 'Source: questionnaire during study visits and remote surveys'}, {'measure': 'Number of days absent from work', 'timeFrame': 'within 2 years post-COVID', 'description': 'Source: questionnaire during study visits and remote surveys'}, {'measure': 'Exploring treatments attempted by patients in the scope of post-COVID symptoms', 'timeFrame': 'within 2 years post-COVID', 'description': 'Categorical options: no treatment; vitamines; antibiotics; puffs; pain medication; anti-inflammatory drugs; others Source: questionnaire during study visits and remote surveys'}, {'measure': 'Exploring the type of counseling patients with post-covid symptoms use.', 'timeFrame': 'within 2 years post-COVID', 'description': 'Categorical options: no counseling; psychologist; physiotherapist; GP; rehabilitation doctor; other Source: questionnaire during study visits and remote surveys'}, {'measure': 'Exploring the meaning of fatigue post-COVID and its impact on their daily lives', 'timeFrame': '+/- 6 months post-COVID', 'description': 'Source: semi-structured interviews online'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'This study is a longitudinal cohort study which investigates the effect of COVID-19 in ambulatory care. This study aims to assess the effect of COVID-19 beyond the acute phase, i.e. on long-term symptoms, respiratory and cardiovascular health, use of health services, and quality of life.', 'detailedDescription': 'This study is a longitudinal cohort study comparing two cohorts. One cohort tested positive for SARS-CoV-2 and the other tested negative for SARS-CoV-2 matched by the timing of testing in the past 6 months. Participants will be observed for two years after their test for COVID-19 with online surveys at different time intervals and face-to-face follow-up visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '2 cohorts of people who experienced an infection in the past 6 months of which 1 group had a proven covid-19 infection and 1 group definitely did not.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants eligible for inclusion in this study for the exposed cohort with a diagnosis of COVID-19 in the last 6 months must meet all of the following criteria:\n\n1. Aged 18 years or older;\n2. Positive result on a rapid Ag test or PCR for SARS-CoV-2 for Covid-19 compatible symptoms a maximum of 6 months before inclusion;\n3. Patient is community-dwelling;\n4. Participant or their proxy is willing and able to give informed consent for participation in this study;\n5. Participant is willing to comply with all study procedures.\n\nParticipants are sampled in the same practices as the exposed cohort and are eligible for inclusion in this study for the non-exposed without a diagnosis of COVID-19 in the last 6 months when they meet all of the following criteria:\n\n1. Aged 18 years or older;\n2. Tested because of suggestive symptoms with a rapid Ag test or PCR for SARS-CoV-2 at the same time (+/- 1 month) as the exposed cohort, of which the result was negative\n3. Patient is community-dwelling;\n4. Participant or their proxy is willing and able to give informed consent for participation in this study;\n5. Participant is willing to comply with all study procedures.\n\nExclusion Criteria:\n\nParticipants eligible for the cohort with COVID-19 in the last 6 months must not meet any of the following criteria:\n\n1. Patients in palliative care;\n2. Patients for whom there is already someone from the same household participating;\n3. Judgement of the recruiting clinician deems participant ineligible.\n\nParticipants eligible for the cohort without COVID-19 must not meet any of the following criteria:\n\n1. A positive test for a SARS-CoV-2 infection in the last 2 years;\n2. Patients in palliative care;\n3. Patients for whom there is already someone from the same household participating;\n4. Judgement of the recruiting clinician deems participant ineligible.\n\nPrior vaccination against Covid-19 is not an exclusion criterion.'}, 'identificationModule': {'nctId': 'NCT05002205', 'acronym': 'CoCo', 'briefTitle': 'Long-term Effects of COVID-19: a Comparative Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Long-term Effects of COVID-19: a Comparative Cohort Study', 'orgStudyIdInfo': {'id': 'S65768'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19', 'description': 'exposed cohort with a diagnosis of COVID-19 in the last 6 months', 'interventionNames': ['Other: Questionnaires', 'Other: spirometry', 'Other: ECG', 'Other: 1 minute sit to stand test', 'Other: Vital parameters']}, {'label': 'no history of COVID-19', 'description': 'non-exposed cohort without a diagnosis of COVID-19. Tested for COVID-19 because of symptoms at the same time (+/- 1 month) as the exposed cohort.', 'interventionNames': ['Other: Questionnaires', 'Other: spirometry', 'Other: ECG', 'Other: 1 minute sit to stand test', 'Other: Vital parameters']}], 'interventions': [{'name': 'Questionnaires', 'type': 'OTHER', 'description': 'Participants will be followed up by means of online surveys and 2 study visits.', 'armGroupLabels': ['COVID-19', 'no history of COVID-19']}, {'name': 'spirometry', 'type': 'OTHER', 'description': 'During two study visits, the lung function will be measured (FVC, FEV1)', 'armGroupLabels': ['COVID-19', 'no history of COVID-19']}, {'name': 'ECG', 'type': 'OTHER', 'otherNames': ['elecrocardiogram'], 'description': 'During two study visits, the presence of arrhythmia will be explored.', 'armGroupLabels': ['COVID-19', 'no history of COVID-19']}, {'name': '1 minute sit to stand test', 'type': 'OTHER', 'description': 'Physical endurance is tested during 2 study visits.', 'armGroupLabels': ['COVID-19', 'no history of COVID-19']}, {'name': 'Vital parameters', 'type': 'OTHER', 'description': 'blood pressure, pulse, weight', 'armGroupLabels': ['COVID-19', 'no history of COVID-19']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Julie Domen, MD', 'role': 'CONTACT', 'email': 'julie.domen@kuleuven.be', 'phone': '016372917'}, {'name': 'Ann Van den Bruel, Prof MD', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Ann Van den Bruel', 'investigatorAffiliation': 'KU Leuven'}}}}