Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2025-12-28 @ 5:12 PM
Study NCT ID:
NCT05805566
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective and Prospective Cohort of Patients Entering the Multidisciplinary Management of Post-Covid Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2029-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2023-04-07', 'studyFirstSubmitQcDate': '2023-04-07', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Create a patient cohort', 'timeFrame': 'Once a year', 'description': 'Creation of a retrospective and prospective cohort combining:\n\n* Collection of clinical and paraclinical data, scores, and scales.\n* Prospective monitoring of quality of life, other scores as needed. Cross-referencing of clinical data with the results of cellular and molecular analyzes on lymphocytes blood cells, which will be carried out (part carried out by Inserm). by INSERM U1111 as part of the European HERVCOV project.'}], 'secondaryOutcomes': [{'measure': 'Identify new research pathway to improve Post-Covid syndrome knowledge', 'timeFrame': '12 month', 'description': 'Description of biological data and clinical and paraclinical data to determine the duration of the syndrome, refine the diagnosis and optimize future management.'}, {'measure': 'Biological analyses to find new molecular targets (biomarkers)', 'timeFrame': '12 month', 'description': 'Biological analyzes of blood constituents for the detection of molecular and/or cellular modifications, which could be at the origin of the symptoms (Carried out by Inserm).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-Covid Syndrome']}, 'descriptionModule': {'briefSummary': 'SARS-CoV2 pneumonia has been a global public health emergency since 2020. The prevalence of the disease is particularly high with more than 500 million cases worldwide (7.5 million in France) since the emergence of the virus.\n\nA substantial proportion of patients with SARS-Cov2 infection present persistent symptoms long after the acute infection. This is independent of the degree of severity of the SARS-Cov2 infection.\n\nThese symptoms can affect the quality of life and impede the return to work. While the majority of symptoms progress favourably with outpatient care, some persist and/or are particularly severe, justifying expert and multidisciplinary care.\n\nThis investigation aim to create a clinical database of patients with complex and/or severe post-CoviD and study blood markers what could predict the disease and orientate new ways of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will focus on adult patients with SARS COV2 whose symptoms persist beyond 4 weeks after the acute phase and who will have integrated the Epsilon care system in the pneumology department of Lyon Sud Hospital.\n\nIt is difficult to define an exact number of subjects because this syndrome is still poorly characterized.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients who have joined the Epsilon care pathway since its opening in February 2022, i.e.:\n\n* Patients with post-Covid syndrome referred to the Epsilon sector from the city medicine:\n* Patient with documented SARS-Cov2 pneumonia\n* With persistent and severe symptoms beyond 4 weeks or complex or disabling symptoms beyond 3 months\n* Patient over 18 years old.\n\nPost-hospital sector:\n\n* Patient with documented SARS-Cov2 pneumonia\n* Hospitalized for oxygen therapy (at least 48h)\n* Not having a referring pulmonologist\n* Not institutionalized\n* With a life expectancy of more than 6 months.\n\nExclusion Criteria:\n\n* Patient refusing that this data to be used for research purposes (objection form).\n* Patient with untreated comorbidities'}, 'identificationModule': {'nctId': 'NCT05805566', 'acronym': 'SyPoCo', 'briefTitle': 'Retrospective and Prospective Cohort of Patients Entering the Multidisciplinary Management of Post-Covid Syndromes', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Post-Covid Syndrome Cohort', 'orgStudyIdInfo': {'id': '69HCL22_1053'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Post-Covid Syndrome Patients', 'interventionNames': ['Other: Blood collection']}], 'interventions': [{'name': 'Blood collection', 'type': 'OTHER', 'description': 'Blood samples will be collected from the patient at baseline. This blood will be collected during the standard of care blood drawing in extra.', 'armGroupLabels': ['Post-Covid Syndrome Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69495', 'city': 'Pierre-Bénite', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sébastien COURAUD, Pr', 'role': 'CONTACT', 'email': 'Sebastien.couraud@chu-lyon.fr'}], 'facility': 'Department of Acute Pneumology and Thoracic Oncology, Hôpital Lyon Sud, Hospices Civils de Lyon', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}], 'centralContacts': [{'name': 'Sébastien COURAUD, Pr', 'role': 'CONTACT', 'email': 'Sebastien.couraud@chu-lyon.fr', 'phone': '+33 (0)4 78 86 44 01'}, {'name': 'Julie DE BERMONT', 'role': 'CONTACT', 'email': 'Julie.de-bermont@chu-lyon.fr', 'phone': '+33 (0)4 78 86 66 98'}], 'overallOfficials': [{'name': 'Sébastien COURAUD, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Acute Pneumology and Thoracic Oncology, Hôpital Lyon Sud, Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}