Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2026-03-03 @ 8:12 AM
Study NCT ID:
NCT05074927
Status:
UNKNOWN
Last Update Posted:
2021-10-12
First Post:
2021-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Function in Patients Recovering From COVID19 Infection : a Pilot 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-08', 'studyFirstSubmitDate': '2021-09-30', 'studyFirstSubmitQcDate': '2021-10-08', 'lastUpdatePostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change diaphragmatic amplitude using diaphragm ultrasonography in patients recovering from SARS-CoV-2 pneumonia.', 'timeFrame': 'at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges', 'description': 'Diaphragmatic amplitude assessed by ultrasound at M0 and M3.'}], 'secondaryOutcomes': [{'measure': 'the correlation between the values of diaphragmatic travel and Pi max and Pe max at M0 and M3.', 'timeFrame': 'at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges', 'description': 'Diaphragmatic amplitude, PI max and PE max'}, {'measure': 'the difference in diaphragmatic amplitude between M0 and M3.', 'timeFrame': 'at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges', 'description': 'Diaphragmatic amplitude at M0 and M3'}, {'measure': 'the difference in FEV1 between M0 and M3.', 'timeFrame': 'at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges', 'description': 'FEV1 at M0 and M3.'}, {'measure': 'the difference in FVC between M0 and M3.', 'timeFrame': 'at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges', 'description': 'FVC at M0 and M3.'}, {'measure': 'the difference in DLCO between M0 and M3.', 'timeFrame': 'at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges', 'description': 'DLCO at M0 and M3.'}, {'measure': 'the difference in Pi max and Pe max between M0 and M3.', 'timeFrame': 'at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges', 'description': 'PI max and PE max at M0 and M3'}, {'measure': 'dyspnoea between M0 and M3.', 'timeFrame': 'at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges', 'description': 'mMRC dyspnoea scale at M0 and M3.'}, {'measure': 'the functional capacity between M0 and M3.', 'timeFrame': 'at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges', 'description': '6-minutes walk test distance at M0 and M3.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung function', 'Diaphragm ultrasonography', 'Chronic Inflammatory Rheumatism'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'The current state of knowledge shows the presence of respiratory sequelae after acute infection with COVID-19 and the importance of these long-term respiratory dysfunctions have to be determined.\n\nAim of our study is describe diaphragmatic amplitude using diaphragm ultrasonography in patients recovering from SARS-CoV-2 pneumonia at 3 and 6 months after the acute episode.', 'detailedDescription': 'patients with confirmed COVID-19 who had been discharged from CHRU Hospital in Limoges (France) will be included to follow the impact of severe acute respiratory syndrom coronavirus 2 on pulmonary function, diaphragm function and exercice capacity. Surviving patients will be evaluated at 3 and 6 months after hospital discharge. The assesment will include diaphragm ultrasonography, spirometry (FEV1,FVC), carbon monoxide transfert (TLCO adjusted for haemoglobin), inspiratory an expiratory respiratory muscle strength (Pimax and Pemax) and 6 minutes walk distance (6MWD).The main outcome will be diaphragm excursion assessed by ultrasound.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* SARS-CoV-2 infection proven by RT-PCR.\n* Patient hospitalised for the management of SARS-CoV-2 infection and included 3 months after the end of his hospitalisation at the CHU of Limoges.\n* Patient of legal age.\n* Patient affiliated to a social security regime.\n* Patient having given informed consent\n\nExclusion Criteria:\n\n* Known pregnancy.\n* Patients who are contraindicated to perform the 6-minute walk test.\n* Patients unable to understand or adhere to the protocol.\n* Patients deprived of liberty.\n* Patients under court order, tutorship or curatorship.\n* Minor patients'}, 'identificationModule': {'nctId': 'NCT05074927', 'acronym': 'EFRUPIC', 'briefTitle': 'Pulmonary Function in Patients Recovering From COVID19 Infection : a Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'Pulmonary Function in Patients Recovering From COVID19 Infection : a Pilot Study', 'orgStudyIdInfo': {'id': '87RI20_0073'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cohort', 'description': 'All patients with confirmed COVID-19 who had been discharged from CHRU Hospital in Limoges (France)', 'interventionNames': ['Diagnostic Test: diaphragm ultrasonography']}], 'interventions': [{'name': 'diaphragm ultrasonography', 'type': 'DIAGNOSTIC_TEST', 'description': 'For all patients with confirmed COVID-19 who had been discharged from CHRU Hospital in Limoges (France) : diaphragm ultrasonography at 3 (M0) and 6 months (M3) after the end of his hospitalisation', 'armGroupLabels': ['Cohort']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'VINCENT François, Pr', 'role': 'CONTACT', 'email': 'francois.vincent@chu-limoges.fr', 'phone': '05 55 05 61 45'}], 'overallOfficials': [{'name': 'VINCENT François, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Limoges'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}