Ignite Creation Date:
2025-12-24 @ 2:40 PM
Ignite Modification Date:
2026-01-01 @ 4:03 PM
Study NCT ID:
NCT04307459
Status:
UNKNOWN
Last Update Posted:
2020-05-13
First Post:
2020-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Respiratory Failure and COVID-19 in Real Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-12', 'studyFirstSubmitDate': '2020-03-10', 'studyFirstSubmitQcDate': '2020-03-10', 'lastUpdatePostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Real life data of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection', 'timeFrame': '1-6 months', 'description': 'Data collection about the real life management of patients affected by SARS-CoV-2 infection with acute respiratory distress syndrome'}], 'secondaryOutcomes': [{'measure': 'in-hospital mortality', 'timeFrame': '1 month', 'description': 'How many patients died during the hospitalization'}, {'measure': '30 days mortality', 'timeFrame': '1 month', 'description': 'How many patients died 30 days after the discharge'}, {'measure': '6 months mortality', 'timeFrame': '6 months', 'description': 'How many patients died 6 months after the discharge'}, {'measure': 'Intubation rate', 'timeFrame': '7 days', 'description': 'How many patients were intubated during the hospitalization'}, {'measure': 'Time to Intubation', 'timeFrame': '7 days', 'description': 'How many days/hours from admittance to intubation'}, {'measure': 'Time to ventilation', 'timeFrame': '7 days', 'description': 'How many days/hours from admittance to the start of non invasive ventilation or CPAP therapy'}, {'measure': 'Non invasive to Invasive time', 'timeFrame': '7 days', 'description': 'How many days/hours from the start of non invasive ventilation or CPAP therapy to the intubation'}, {'measure': 'Recovery rate', 'timeFrame': '1 month', 'description': 'How many patients were healed from the infection and discharged'}, {'measure': 'Recurrence rate', 'timeFrame': '1 month', 'description': 'How many patients underwent re-infection after previous recovery from COVID19'}, {'measure': 'Risk factor for COVID19', 'timeFrame': 'retrospective', 'description': 'Assessment of the risk factors for the infection and the admission to the hospital'}, {'measure': 'Blood tests and outcome', 'timeFrame': '1 month', 'description': 'What serological parameter could be used as predictor of good or negative prognosis.'}, {'measure': 'Antiviral therapy', 'timeFrame': '1 month', 'description': 'Impact of antiviral therapy on the clinical course of the disease'}, {'measure': 'Coinfections', 'timeFrame': '1 month', 'description': 'Assessment of bacterial, fungal or other coinfections rate'}, {'measure': 'Radiological findings', 'timeFrame': '1 month', 'description': 'Impact of radiological findings on the clinical course and the outcome'}, {'measure': 'Ultrasound findings', 'timeFrame': '1 month', 'description': 'Impact of ultrasound findings on the clinical course and the outcome'}, {'measure': 'Myocardial injury', 'timeFrame': '1 month', 'description': 'Assessment of the evidence of myocardial injury in covid19+ patients'}, {'measure': 'Medical management', 'timeFrame': '1 month', 'description': 'impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sars', 'acute respiratory failure', 'CPAP therapy', 'non invasive ventilation', 'gas exchange'], 'conditions': ['Coronavirus Infections', 'Respiratory Failure', 'Ventilator Lung']}, 'referencesModule': {'references': [{'pmid': '33040020', 'type': 'DERIVED', 'citation': 'Santus P, Radovanovic D, Saderi L, Marino P, Cogliati C, De Filippis G, Rizzi M, Franceschi E, Pini S, Giuliani F, Del Medico M, Nucera G, Valenti V, Tursi F, Sotgiu G. Severity of respiratory failure at admission and in-hospital mortality in patients with COVID-19: a prospective observational multicentre study. BMJ Open. 2020 Oct 10;10(10):e043651. doi: 10.1136/bmjopen-2020-043651.'}]}, 'descriptionModule': {'briefSummary': 'In December 2019 a new kind of virus was identified in China as the responsible of severe acute respiratory syndrome (SARS) and interstitial pneumonia. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quickly spread around the world and in February 2020 became a pandemia in Europe.\n\nNo pharmacological treatment is actually licensed for the SARS-CoV2 infection and at the current state of art there is a lack of data about the clinical management of the coronavirus 2019 disease (COVID-19).\n\nThe aim of this observational study is to collect the data and the outcomes of COVID-19 patients admitted in the H. Sacco Respiratory Unit treated according to the Standard Operating Procedures and the Good Clinical Practice.', 'detailedDescription': 'All consecutive adult COVID-19 patients admitted to our Respiratory Unit will be enrolled. All demographic, anthropometric, laboratory, radiological, clinical and microbiological data will be collected and analyzed according to the primary and secondary outcomes (see the dedicated section).\n\nDuring the hospitalization, patients will be treated according to the standard operating procedure of our Respiratory Unit, such as arterial gas analysis, Rx, pharmacological treatment, ventilation. This study is purely observational and no randomization will be performed.\n\nAfter discharge, patients a 7 days, 30 days and 6 months follow up will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with SARS-CoV2 pulmonary disease admitted to the H. Sacco respiratory unit will be enrolled in the observational study (see exclusion criteria).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients that can give written or oral informed consent\n* patients with microbiological diagnosis (i.e. rhinopharyngeal swab) of SARS-CoV2 infection\n\nExclusion Criteria:\n\n* severe cognitive impairment\n* absolute contraindication to non invasive ventilation or cpap therapy\n* rhinopharyngeal swab negative for SARS-CoV2'}, 'identificationModule': {'nctId': 'NCT04307459', 'briefTitle': 'Acute Respiratory Failure and COVID-19 in Real Life', 'organization': {'class': 'OTHER', 'fullName': 'University of Milan'}, 'officialTitle': 'Acute Respiratory Failure and Continuous Positive Airway Pressure Therapy in Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: a Real Life Evaluation', 'orgStudyIdInfo': {'id': '17263/2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Coronavirus Infection', 'description': 'All patients admitted to the Respiratory Unit with SARS-CoV-2 infection and respiratory failure', 'interventionNames': ['Other: standard operating procedures']}], 'interventions': [{'name': 'standard operating procedures', 'type': 'OTHER', 'description': 'standard operating procedures represented by continuous positive airway pressure (CPAP) therapy or non invasive ventilation, pharmacological treatment as antiviral and antibiotic drugs, bronchodilators, xanthines, enteral nutrition, hydration.', 'armGroupLabels': ['Coronavirus Infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20157', 'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pierachille Santus, MD, PhD', 'role': 'CONTACT', 'email': 'pierachille.santus@unimi.it', 'phone': '0239042801'}, {'name': 'Elisa Franceschi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dejan Radovanovic, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pierachille Santus, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Luigi Sacco University Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Pierachille Santus, MD, PhD', 'role': 'CONTACT', 'email': 'pierachille.santus@unimi.it', 'phone': '+390239042801'}, {'name': 'Elisa Franceschi, MD', 'role': 'CONTACT', 'email': 'elisa.franceschi@unimi.it', 'phone': '+390239042277'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Head of Respiratory Disease Unit H sacco', 'investigatorFullName': 'Pierachille Santus, MD, PhD', 'investigatorAffiliation': 'University of Milan'}}}}