Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-31 @ 12:29 PM
Study NCT ID:
NCT05226403
Status:
COMPLETED
Last Update Posted:
2022-02-07
First Post:
2022-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 : Pulmonary Ultrasound in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-04', 'studyFirstSubmitDate': '2022-01-26', 'studyFirstSubmitQcDate': '2022-02-04', 'lastUpdatePostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultrasound Signs', 'timeFrame': 'Between day 5 and day 10 of infection', 'description': 'Frequency of the presence of at least one ultrasound sign in the subjects included'}], 'secondaryOutcomes': [{'measure': 'Clinical Signs', 'timeFrame': 'Day 5 and Day 10', 'description': 'Clinical signs positives in the cas of presence one of these elements: Hypoxia, Tachypnée, Pathological pulmonary auscultation.'}, {'measure': 'Ultrasound signs', 'timeFrame': 'Between day 5 and day 10', 'description': 'Ultrasound signs positives in the case of presence one of these elements: Disappearance of lines A, Appearance of three lines B, Appearance of pulmonary condensation.'}, {'measure': 'Evolution and complication', 'timeFrame': 'Day 14 of infection', 'description': 'Number of deaths and patients admitted to hospital for worsening of respiratory signs of infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID19'], 'conditions': ['Covid19', 'Pulmonary Infection', 'Ultrasound Therapy; Complications', 'Respiratory Infection']}, 'descriptionModule': {'briefSummary': 'COVID-19 infection are characterized by fever and signs of acute respiratory infection. A worsening of respiratory symptoms that can lead to respiratory failure. The decompensation can then be brutal and require rapid recourse to respiratory assistance. The contribution of clinical examination (auscultation and monitoring of oxygen saturation in particular) remains unsatisfactory in predicting an unfavorable course. The interest of pulmonary ultrasound is known in the management of pulmonary infections. However, estimating the severity of lung damage at an early stage could be of great help in monitoring and caring for patients. Ultrasound could meet this need in general practice, the chest scanner is often unavailable in these situations.\n\nUltrasound signs are associated with severe forms. The contribution of pulmonary ultrasound seems particularly interesting in the context of the reassessment of patients during the worsening phase of symptoms (D5-D10).\n\nEstimate the prevalence of ultrasound signs in patients with an acute respiratory infection suspected or confirmed to be COVID-19, at the time of the worsening phase (between D5 and D10 of the onset of symptoms).\n\nThe prevalence of ultrasound lung lesions under COVID-19 may be essential to consider the development of the ultrasound tool in primary care. Indeed, if the contribution of ultrasound is now recognized in intensive care or emergency, its place in general medicine still raises questions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with acute respiratory infection linked to COVID-19', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients over 18 years of age with :\n\n * a clinical symptomatology suggesting an acute respiratory infection linked to COVID-19 defined by the following two categories of symptoms:\n\n * Sudden fever (or a feeling of fever)\n * Respiratory signs (cough, dyspnea, chest tightness) Or\n * an acute respiratory infection confirmed to COVID-19 by the result of RT-PCR screening tests.\n2. And presenting, at the time of inclusion between the 5th and 10th day of infection, one of the respiratory signs of severity felt:\n\n * Dyspnea, shortness of breath or difficulty in breathing\n * Chest pain or tightness\n\nExclusion Criteria:\n\n1. The presence of a severe form during the initial consultation. A severe form is defined by the presence of the following signs:\n\n * Polypnea\\> 22 / min\n * systolic BP \\<90 mmHg\n * Sp02 \\<90%\n * Altered consciousness, confusion, drowsiness\n * Dehydration\n * Alteration of the general condition in the elderly\n2. The presence of acute respiratory signs clearly having a cause other than a COVID-19 infection.'}, 'identificationModule': {'nctId': 'NCT05226403', 'acronym': 'ECHOVID-MG', 'briefTitle': 'COVID-19 : Pulmonary Ultrasound in Primary Care', 'organization': {'class': 'NETWORK', 'fullName': 'Geprovas'}, 'officialTitle': 'Descriptive Study of Clinical and Pulmonary Ultrasound Signs of Acute Respiratory Infections Associated With COVID-19 in Primary Care', 'orgStudyIdInfo': {'id': '2020-A01225-34'}}, 'contactsLocationsModule': {'locations': [{'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'GEPROVAS', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Geprovas', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}