Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT04815304
Status:
COMPLETED
Last Update Posted:
2023-11-27
First Post:
2021-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Features of COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D007040', 'term': 'Hypoventilation'}], '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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001784', 'term': 'Blood Gas Analysis'}, {'id': 'D010147', 'term': 'Pain Measurement'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009460', 'term': 'Neurologic Examination'}, {'id': 'D010808', 'term': 'Physical Examination'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-23', 'studyFirstSubmitDate': '2021-03-19', 'studyFirstSubmitQcDate': '2021-03-23', 'lastUpdatePostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peripheral lymphocyte subsets', 'timeFrame': 'Change from date of hospitalization until the date of hospital discharge or date of death from any cause, whichever came first, assessed at 60 weeks', 'description': 'Peripheral lymphocyte subsets were measured by multiple-color flow cytometry,'}], 'secondaryOutcomes': [{'measure': 'Chest computed tomography', 'timeFrame': 'From date of hospitalization until the date of hospital discharge or date of death from any cause, whichever came first, assessed every 10 days up to 60 weeks', 'description': 'A chest computed tomography performed to assess lung damage'}, {'measure': 'Chest ultrasonography', 'timeFrame': 'From date of hospitalization until the date of hospital discharge or date of death from any cause, whichever came first, assessed every day up to 60 weeks', 'description': 'Lung ultrasound score (sum of points in all 12 regions and ranges from 0 to 36; 0 points-presence of lung sliding with A lines or one or two isolated B lines; 1 point-moderate loss of lung aeration with three or four B lines (septal rockets); 2 points-severe loss of lung aeration with five or more B lines (glass rockets); and 3 points-presence of a hypoechoic poorly defined tissue characterized by consolidation)'}, {'measure': 'Pain assessment', 'timeFrame': 'From date of hospitalization until the date of hospital discharge or date of death from any cause, whichever came first, assessed every day up to 60 weeks', 'description': 'Pain assessed by using numeric rating scale (the 11-point numeric scale ranges from \'0\' representing one pain extreme \\[e.g. "no pain"\\] to \'10\' representing the other pain extreme \\[e.g. "pain as bad as you can imagine" or "worst pain imaginable\\])'}, {'measure': 'Upper airway damages', 'timeFrame': 'From date of hospitalization until the date of hospital discharge or date of death from any cause, whichever came first, assessed every day up to 60 weeks', 'description': 'Macroscopic and microscopic hypopharynx and larynx damages evaluated by video-laryngoscopy and light microscopy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Acute Respiratory Distress Syndrome', 'Ventilatory Failure']}, 'descriptionModule': {'briefSummary': 'The data were retrospectively collected during the first and the second wave of epidemic in COVID-19 patients with Severe Acute Respiratory Syndrome Coronavirus 2, at the moment of intensive care unit admission and during the in intensive care unit staying.', 'detailedDescription': 'At the moment of intensive care unit admission and during the in intensive care unit staying, the following data were collected: peripheral lymphocyte subsets were measured by multiple-color flow cytometry, chest computed tomography and ultrasonography scans, arterial blood gas parameters (pH, partial pressure of carbon dioxide, partial pressure of oxygen, concentration of hydrogen carbonate, base excess, and arterial oxygen saturation), and pain assessed by using numeric rating scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The data were collected during the first and the second wave of epidemic in COVID-19 patients with acute respiratory distress syndrome', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COVID-19 patients\n* Acute respiratory distress syndrome\n* needing of ventilatory support\n\nExclusion Criteria:\n\n* asymptomatic COVID-19 patients\n* few symptoms\n* mild symptoms\n* without needing of ventilatory support'}, 'identificationModule': {'nctId': 'NCT04815304', 'briefTitle': 'Clinical Features of COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': "San Salvatore Hospital of L'Aquila"}, 'officialTitle': "Clinical Features of Severe Acute Respiratory Syndrome Coronavirus 2 Patients Admitted to the Intensive Care Units of Academic Hospital of L'Aquila (Italy)", 'orgStudyIdInfo': {'id': '26100/21'}}, 'armsInterventionsModule': {'interventions': [{'name': 'peripheral lymphocytes subsets', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Chest computed tomography', 'Chest ultrasonography scan', 'arterial blood gas analysis', 'pain'], 'description': 'The data were collected during the first and the second wave of epidemic in COVID-19 patients with acute respiratory distress syndrome. At the moment of hospitalization, at the moment of intensive care unit admission and during the in intensive care unit staying, the following data were collected: peripheral lymphocyte subsets were measured by multiple-color flow cytometry, chest computed tomography and ultrasonography scans (lung ultrasound score, diaphragmatic thickness and motion), arterial blood gas analysis parameters (pH, partial pressure of carbon dioxide, partial pressure of oxygen, concentration of hydrogen carbonate, base excess, and arterial oxygen saturation ), and pain assessed by using numeric rating scale. Macroscopic and microscopic hypopharynx and larynx damages were also evaluated by video-laryngoscopy and light miscoscopy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '67100', 'city': 'L’Aquila', 'country': 'Italy', 'facility': 'San Salvatore Academic Hospital', 'geoPoint': {'lat': 42.35055, 'lon': 13.39954}}], 'overallOfficials': [{'name': 'Franco Marinangeli, MD', 'role': 'STUDY_CHAIR', 'affiliation': "ASL 1 Avezzano Sulmona L'Aquila"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "San Salvatore Hospital of L'Aquila", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Emiliano Petrucci', 'investigatorAffiliation': "San Salvatore Hospital of L'Aquila"}}}}