Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT04519320
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-23
First Post:
2020-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Medium and Long Term Follow-up of COVID-19 Infected Patients: Research and Characterization of Pulmonary Sequelae
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D000070857', 'term': 'Walk Test'}, {'id': 'D001784', 'term': 'Blood Gas Analysis'}, {'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D005080', 'term': 'Exercise Test'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-08-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-22', 'studyFirstSubmitDate': '2020-08-18', 'studyFirstSubmitQcDate': '2020-08-18', 'lastUpdatePostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of patients with an alteration of the capillary alveolus barrier at 12 months of follow-up, characterized by a decreased of the diffusing capacity for carbon monoxide (DLCO) below the lower limit of normal', 'timeFrame': '12 months after the first symptoms of SARS-COV-2', 'description': 'DLCO'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sars-CoV2']}, 'referencesModule': {'references': [{'pmid': '36635717', 'type': 'DERIVED', 'citation': 'Noureddine S, Roux-Claude P, Laurent L, Ritter O, Dolla P, Karaer S, Claude F, Eberst G, Westeel V, Barnig C. Evaluation of long-term sequelae by cardiopulmonary exercise testing 12 months after hospitalization for severe COVID-19. BMC Pulm Med. 2023 Jan 12;23(1):13. doi: 10.1186/s12890-023-02313-x.'}, {'pmid': '35262794', 'type': 'DERIVED', 'citation': 'Eberst G, Claude F, Laurent L, Meurisse A, Roux-Claude P, Barnig C, Vernerey D, Paget-Bailly S, Bouiller K, Chirouze C, Behr J, Grillet F, Ritter O, Karaer S, Pili-Floury S, Winiszewski H, Samain E, Decavel P, Capellier G, Westeel V. Result of one-year, prospective follow-up of intensive care unit survivors after SARS-CoV-2 pneumonia. Ann Intensive Care. 2022 Mar 9;12(1):23. doi: 10.1186/s13613-022-00997-8.'}]}, 'descriptionModule': {'briefSummary': 'Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of atypical emerging pneumonia. The clinical spectrum varies from an asymptomatic or mild illness to a serious illness with a high risk of mortality. The most severely affected patients (5%) present an acute respiratory distress syndrome (ARDS), requiring assistance with mechanical ventilation in intensive care.\n\nIn 2003, persistent lung damage was observed in a third of patients in a Singaporean cohort one year after SARS-CoV infection. A Chinese study showed that 27.3% of their SARS-CoV patients presented a decreased carbon monoxide diffusion (DLCO) and 21.5% of pulmonary fibrosis lesions.\n\nDue to the very recent emergence of SARS-CoV-2, no data is currently available of long-term outcome of these patients. However, recent publications including short-term CT monitoring suggest the genesis of fibrotic pulmonary parenchymal sequelae.\n\nIn view of these data, the investigators can fear the occurrence of pulmonary sequelae in patients infected with SARS-CoV-2. It is therefore essential to evaluate the evolution of the respiratory status of the most severe patients who have had a stay in intensive care with respiratory assistance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient infected by SARS-CoV-2 (diagnosed by RT-PCR and / or typical CT imaging)\n* Patient hospitalized in the intensive care units of Besançon or Dijon hospitals for severe SARS-CoV-2 pneumonia\n* Postmenopausal woman for at least 24 months or surgically sterilized, or, for woman of childbearing age, use of an effective method of contraception\n* Signature of informed consent to participate indicating that the subject has understood the purpose and the procedures required by the study and that he agrees to participate in the study.\n* Affiliation to a French social security system .\n\nExclusion Criteria:\n\n* Chronic respiratory failure under long-term oxygen therapy\n* Known diffuse invasive pneumonia\n* Life expectancy estimated at less than one year by the doctor\n* Legal incapacity or limited legal capacity\n* History of psychiatric illness, intellectual disability, lack of motivation or other conditions that may limit the understanding of informed consent\n* Subject unlikely to cooperate in the study and / or weak cooperation anticipated by the investigator\n* Subject without health insurance\n* Pregnant and / or lactating woman\n* Subject being in the exclusion period of another study or foreseen by the "national file of the volunteers".'}, 'identificationModule': {'nctId': 'NCT04519320', 'acronym': 'COV-RECUP', 'briefTitle': 'Medium and Long Term Follow-up of COVID-19 Infected Patients: Research and Characterization of Pulmonary Sequelae', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Medium and Long Term Follow-up of SARS-COV-2 Infected Patients Treated at Besançon and Dijon Hospitals: Research and Characterization of Pulmonary Sequelae', 'orgStudyIdInfo': {'id': '2020/499'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'SARS-COV 2 Patients', 'interventionNames': ['Diagnostic Test: Pulmonary function testing']}], 'interventions': [{'name': 'Pulmonary function testing', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['CT Scan', 'Six minute walk test', 'Pulmonary Exercise Stress Test', 'Blood gases', 'Ventilatory polygraphy', 'Questionnaires: HADS and MOS SF-36', 'Blood Test'], 'description': 'D0: date of first symptoms of SARS-COV-2\n\nM3: D0 + 3 months\n\n* Blood test\n* Blood gases\n* Clinical examination\n* CT Scan\n* Pulmonary function testing (PFT)\n* 6-minute walk test (6MWT)\n* MOS SF-36 Questionnaire\n* HADS scale\n* Ventilatory polygraphy\n\nM6: D0 + 6 months\n\n* Clinical examination\n* PFT\n* 6MWT\n* MOS SF-36 Questionnaire\n* HADS scale\n\nM12: D0 + 12 months\n\n* Blood test\n* Blood gases\n* Clinical examination\n* CT Scan (If anomaly found at M3)\n* PFT\n* Pulmonary Exercise Stress Test\n* 6MWT\n* MOS SF-36 Questionnaire\n* HADS scale\n\nSubsequent follow-up will be performed only in patients with an alteration defined by a DLCO \\<LLN and / or an abnormality objectified at CT-Scan attributable to SARS-CoV-2.\n\nM24, M36, M48 and M60: D0 + 24, 36, 48, 60 months\n\n* Clinical examination\n* PFT\n* 6MWT\n* MOS SF-36 Questionnaire\n* HADS scale', 'armGroupLabels': ['SARS-COV 2 Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'state': 'Franche-Comté', 'country': 'France', 'facility': 'CHU Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}