Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-04 @ 2:20 AM
Study NCT ID:
NCT04817293
Status:
UNKNOWN
Last Update Posted:
2022-05-10
First Post:
2021-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prolonged Symptoms and Reasons for Consultation in Town Medicine Associated With COVID-19 Infection in the Hauts de France Region
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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-09', 'studyFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2021-03-25', 'lastUpdatePostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the reasons for consultation between patients with a history of Covid 19 and those who have not been infected with SARS-CoV-2.', 'timeFrame': 'At day 1', 'description': 'The judgement criterion will be the reasons for consultation standardized with the CISP-2 classification (International Classification of Primary Care).'}], 'secondaryOutcomes': [{'measure': 'To Assess the presence of somatoform disorders between COVID-19 and non-COVID-19 patients.', 'timeFrame': 'At day 1', 'description': 'The assessment will be done using the international SSD-12 scale (Symptom Disorder-B Criteria Scale). The SSD-12 is composed of 12 items; each of the three psychological subcriteria is measured by four items (cognitive aspects; affective aspects; behavioral aspects).'}, {'measure': 'To compare the quality of life of COVID-19 patients with that of non-COVID-19 patients.', 'timeFrame': 'At day 1', 'description': "The EQ-5D-5L scale is composed of - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Each level corresponds to 1-digit number expressing the level selected for that dimension.The EQ VAS corresponds to a 20 cm vertical, visual analogue scale raging from 'the best health you can imagine' to 'the worst health you can imagine'."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'Several publications document the occurrence of prolonged or late-onset symptoms beyond 3 weeks after the first clinical manifestations of SARS-COV2 infection. These manifestations may be related to thromboembolic or inflammatory events or other mechanisms that are not yet well understood. The psychosomatic origin secondary to psychiatric disorders prior to the infection or in reaction to it is also to be evoked. The identification of the clinical manifestations observed, and their clinical and paraclinical evolution are essential to better understand the natural evolution of COVID-19, to specify the physiopathological mechanisms and to identify potential avenues of management for the patients. In addition, the impact of COVID-19 infection on primary care visits is not known. In general practice, these patients benefit from explorations and even diagnoses that may explain the persistence of symptoms (autoimmune diseases, thrombosis, somatoform disorders, hyperventilation syndrome, etc.).\n\nThe objective of the COCO\\_Vi\\_LATE project is to carry out a cross-sectional study of patients presenting persistent and/or recurrent symptoms after an infection with SARS-COV-2 who will be compared to individuals with a short form of infection with COVID-19'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'he study population consisted of patients with COVID-19 infection and patients without COVID-19 infection consulting their general practitioner during the study inclusion period.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nA- For COVID cases:\n\n1. Consultation in a city doctor's office\n2. Positive SARS-CoV-2 RT-PCR result OR positive SARS-CoV-2 serology\n3. Patient symptomatic or not\n\nDefinition of symptomatic :\n\n1. Anosmia\n2. OR CT scan suggestive of COVID 19\n3. OR ≥ 2 symptoms contemporaneous with virologic sampling among: asthenia, cough, dyspnea, fever, myalgias, dysgeusia, diarrhea AND not present previously at diagnosis\n\nB-. For NON COVID cases:\n\n1. Consultation in a city doctor's office\n2. No known COVID+ serology\n3. No known RT- PCR SARS-CoV-2\n4. No clinical suspicion of COVID-19 infection\n\nExclusion Criteria:\n\n1. Minor patient\n2. Refusal to participate\n3. Patient under protection\n4. Patient requiring hospitalization for COVID-19 (excluding non-emergency hospitalization)\n5. Patient consulted for the following reason only: treatment monitoring, treatment renewal or certificate, hospital discharge"}, 'identificationModule': {'nctId': 'NCT04817293', 'acronym': 'COCO_Vi_LATE', 'briefTitle': 'Prolonged Symptoms and Reasons for Consultation in Town Medicine Associated With COVID-19 Infection in the Hauts de France Region', 'organization': {'class': 'OTHER', 'fullName': 'Tourcoing Hospital'}, 'officialTitle': 'Coordinated Research on Prolonged Symptoms and Reasons for Consultation in Town Medicine Associated With SARS-COV-2 Infection: a Transversal Study in Town in the Hauts de France Region', 'orgStudyIdInfo': {'id': 'RIPH_2021_01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 positive', 'interventionNames': ['Other: Questionnaire', 'Other: medical consultation']}, {'label': 'COVID-19 negative', 'interventionNames': ['Other: Questionnaire', 'Other: medical consultation']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Questionnaire SSD-12 and EQ5D5L', 'armGroupLabels': ['COVID-19 negative', 'COVID-19 positive']}, {'name': 'medical consultation', 'type': 'OTHER', 'description': 'Medical consultation during the visit with data collection', 'armGroupLabels': ['COVID-19 negative', 'COVID-19 positive']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tourcoing', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CH Tourcoing', 'geoPoint': {'lat': 50.72391, 'lon': 3.16117}}], 'centralContacts': [{'name': 'Olivier ROBINEAU, MD', 'role': 'CONTACT', 'email': 'orobineau@ch-tourcoing.fr', 'phone': '0320694949'}, {'name': 'Solange TREHOUX, PhD', 'role': 'CONTACT', 'email': 'strehoux@ch-tourcoing.fr', 'phone': '0320694280'}], 'overallOfficials': [{'name': 'Olivier ROBINEAU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH TOURCOING'}, {'name': 'Sophie PANAGET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU LILLE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tourcoing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}