Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-17 @ 9:49 AM
Study NCT ID:
NCT04443257
Status:
TERMINATED
Last Update Posted:
2023-02-21
First Post:
2020-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REassessement After Hospitalization for Sars-COV-2 disordER
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'not enough inclusions', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-16', 'studyFirstSubmitDate': '2020-06-20', 'studyFirstSubmitQcDate': '2020-06-20', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development or worsening of a ventilatory disorder and/or chronic respiratory failure assessed by spirometry', 'timeFrame': '3 to 6 months after Sars coV 2 infection'}], 'secondaryOutcomes': [{'measure': 'Assessment of dyspnea', 'timeFrame': '3 to 6 months after Sars coV 2 infection', 'description': 'assessed by 0-10 Borg scale'}, {'measure': 'Description of pulmonary lesions as assessed by lung CT scan', 'timeFrame': '3 to 6 months after Sars coV 2 infection', 'description': 'assessed by lung CT scan'}, {'measure': 'Development of pulmonary fibrosis as assessed by lung CT scan', 'timeFrame': '3 to 6 months after Sars coV 2 infection', 'description': 'assessed by lung CT scan'}, {'measure': 'Incidence or worsening of cardiovascular diseases', 'timeFrame': '3 to 6 months after Sars coV 2 infection', 'description': 'assessed by incidence of cardiovascular events, venous thromboembolism, and transthoracic echocardiogram'}, {'measure': 'Incidence or worsening of renal disease', 'timeFrame': '3 to 6 months after Sars coV 2 infection', 'description': 'renal function and urinary parameters'}, {'measure': 'Incidence or worsening of liver disease', 'timeFrame': '3 to 6 months after Sars coV 2 infection', 'description': 'hepatic blood parameters'}, {'measure': 'Incidence or worsening of psychological pathology : anxiety', 'timeFrame': '3 to 6 months after Sars coV 2 infection', 'description': 'assessed by validated scale: Generalized Anxiety Disorder-7 (GAD7)'}, {'measure': 'Incidence or worsening of psychological pathology: depression', 'timeFrame': '3 to 6 months after Sars coV 2 infection', 'description': 'assessed by validated scales: Patient Health Questionnaire-9 (PHQ9)'}, {'measure': 'Incidence or worsening of psychological pathology: post-traumatic stress', 'timeFrame': '3 to 6 months after Sars coV 2 infection', 'description': 'assessed by validated scale : Post-traumatic Checklist for DSM-5 (PCL-5)'}, {'measure': 'Incidence or worsening of psychological pathology: insomnia', 'timeFrame': '3 to 6 months after Sars coV 2 infection', 'description': 'assessed by validated scale : insomnia severity index (ISI)'}, {'measure': 'Assessment of the health-related quality of life', 'timeFrame': '3 to 6 months after Sars coV 2 infection', 'description': 'assessed by validated scale (EQ-5D-L questionnaire)'}, {'measure': 'Assessment of the fatigue', 'timeFrame': '3 to 6 months after Sars coV 2 infection', 'description': 'assessed by the fatigue severity sale'}, {'measure': 'Assessment of the socioeconomic deprivation', 'timeFrame': '3 to 6 months after Sars coV 2 infection', 'description': 'assessed by the Evaluation of Deprivation and Inequalities in Health Examination (EPICES) scale'}, {'measure': 'development or worsening of metabolic disorders: diabetes, thyroid diseases, dyslipidemia, adrenal disorders, malnutrition', 'timeFrame': '3 to 6 months after Sars coV 2 infection', 'description': 'assessed by blood glucose level, HbA1C, lipid blood tests, TSH, T3, T4, antithyroperoxydase antibodies, cortisol, ACTH, renin, aldosteron, albumin level, vitamin D level, iron status, weight changes'}, {'measure': 'Development of auto-immune disorders', 'timeFrame': '3 to 6 months after Sars coV 2 infection', 'description': 'assessed by lupus anticoagulant, anti-cardiolipin, anti-β2-glycoprotein'}, {'measure': 'Assessment of the evolution of the humoral anti-SARS-CoV-2 immunization profile', 'timeFrame': '3 to 6 months after Sars coV 2 infection', 'description': 'Presence and levels of anti-SARS-CoV-2 antibodies of IgG, IgA and IgM isotypes'}, {'measure': "Patients' self-reported level of physical activity", 'timeFrame': '3 to 6 months after Sars coV 2 infection', 'description': 'assessed by the International Physical Activity Questionnaire (IPAQ)'}, {'measure': 'Determination of risk factors associated with sequelae or comorbidities', 'timeFrame': '3 to 6 months after Sars coV 2 infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['comorbidities', 'Sars-CoV2', 'sequelae', 'patient outcome assessment', 'Covid19', 'quality of life'], 'conditions': ['Sars-CoV2']}, 'referencesModule': {'references': [{'pmid': '36769648', 'type': 'RESULT', 'citation': 'Berger M, Daubin D, Charriot J, Klouche K, Le Moing V, Morquin D, Halimi L, Jaussent A, Taourel P, Hayot M, Cristol JP, Nagot N, Fesler P, Roubille C. Mid-Term Sequelae of Surviving Patients Hospitalized in Intensive Care Unit for COVID-19 Infection: The REHCOVER Study. J Clin Med. 2023 Jan 28;12(3):1000. doi: 10.3390/jcm12031000.'}]}, 'descriptionModule': {'briefSummary': 'Currently, the sequelae and short-term medical and psychological impact of the sars-cov-2 infection ("CoVID-19") remain poorly described. The clinical and functional sequelae that may persist after acute sars-cov-2 ("CoVID-19") infection are essential to explore, in order to ensure the best possible follow-up of patients after discharge from hospital.', 'detailedDescription': 'Since sars-cov-2 ("CoVID-19") is a newly defined infection, its sequelae and short-term medical and psychological impact remain poorly described.The clinical and functional sequelae that may persist after acute sars-cov-2 ("CoVID-19") infection are essential to explore, in order to ensure the best possible follow-up of patients after discharge from hospital.\n\nIndeed, some patients may develop chronic respiratory failure, pulmonary fibrosis, or other comorbidities including cardiovascular or metabolic diseases. The psychological impact is also essential to assess. The sequelae and comorbidities of patients could also vary depending on the severity of the initial acute involvement.\n\nInvestigators propose to explore the sequelae of patients who have been hospitalized for acute sars-cov-2 infection, between 3 to 6 months after discharge from hospital, by characterizing the incidence of chronic respiratory failure and fibrosis, as well as of various comorbidities such as cardiovascular, metabolic, and psychological diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult who was hospitalized within 3 to 6 months for a sars-CoV infection at Montpellier University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient who was hospitalized within 3 to 6 months for a sars-CoV infection\n\nExclusion Criteria:\n\n* Absence of signed informed consent\n* pregnancy or breastfeeding\n* patient under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT04443257', 'acronym': 'REHCOVER', 'briefTitle': 'REassessement After Hospitalization for Sars-COV-2 disordER', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'REassessement After Hospitalization for Sars-COV-2 Infection : Standardized Assessment of Sequelae and Comorbidities 3 to 6 Months After Hospitalization', 'orgStudyIdInfo': {'id': 'RECHMPL20_0340'}}, 'armsInterventionsModule': {'interventions': [{'name': 'assessment of the sequelae after hospitalization for Sars-COV-2', 'type': 'OTHER', 'description': 'the incidence of chronic respiratory failure and fibrosis, as well as of comorbidities including cardiovascular, metabolic, renal, hepatic, neurological, and psychological diseases'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'University hospital of Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '12 months after the main publication', 'ipdSharing': 'YES', 'description': 'Data will be made available upon a reasonable request', 'accessCriteria': 'Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and institutional review board (IRB) review. Dataset will be shared after careful examination by the study board of investigators.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}