Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-30 @ 7:46 PM
Study NCT ID:
NCT04342104
Status:
UNKNOWN
Last Update Posted:
2021-08-30
First Post:
2020-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NIV and CPAP Failure Predictors in COVID-19 Associated Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood sample for biochemistry and blood count'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-26', 'studyFirstSubmitDate': '2020-04-08', 'studyFirstSubmitQcDate': '2020-04-08', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HACOR score efficacy', 'timeFrame': '1 hour after initation of CPAP or NIV', 'description': 'Analyze if HACOR score is effective in predicting nonivasive ventilation failure in COVID-19 associated respiratory failure'}, {'measure': 'HACOR score addaptation', 'timeFrame': '1 - 2 weeks', 'description': 'Analyze the role of possible variables to be added to HACOR score in order to improve efficay in COVID-19 patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['noninvasive ventilation', 'CPAP', 'Covid-19', 'Respiratory failure', 'HACOR score'], 'conditions': ['Respiratory Failure', 'Covid-19']}, 'descriptionModule': {'briefSummary': 'Evaluate HACOR socre utility and efficacy in predicting NIV and/or CPAP failure in patients with COVID-19 associated respiratory failure.\n\nPropose adaptations to HACOR score based on the "state of art" of COVID-19', 'detailedDescription': 'Evaluate HACOR socre utility and efficacy in predicting NIV and/or CPAP failure in patients with COVID-19 associated respiratory failure.\n\nPropose adaptations to HACOR score based on the "state of art" of COVID-19\n\n\\- this adaptations may include radiologic aggravation and monitoring of CRF, ferritin, LDH, d-dimers, NT-proBNP, troponin I, GOT, GPT, blood count'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute respiratory failure due to COVID-19 who have initiated NIV or CPAP based on assistant clinician decision', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with acute respiratory failure due to COVID-19 who have initiated NIV or CPAP based on assistant clinician decision\n\nExclusion Criteria:\n\n* Patients with imediate indication to invasive mechanical ventilation\n* Patients with any formal contraindication to noninvasive respiratory support'}, 'identificationModule': {'nctId': 'NCT04342104', 'briefTitle': 'NIV and CPAP Failure Predictors in COVID-19 Associated Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario Morales Meseguer'}, 'officialTitle': 'NIV and CPAP Failure Predictors in COVID-19 Associated Respiratory Failure', 'orgStudyIdInfo': {'id': '08-04-2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NIV', 'description': 'Patients on Bilevel NIV', 'interventionNames': ['Other: Monitoring for aggravation', 'Other: Evaluate HACOR score effectivity in this patients']}, {'label': 'CPAP', 'description': 'Patients on CPAP', 'interventionNames': ['Other: Monitoring for aggravation', 'Other: Evaluate HACOR score effectivity in this patients']}], 'interventions': [{'name': 'Monitoring for aggravation', 'type': 'OTHER', 'description': 'Monitor patients on CPAP or NIV and analyzing possible variables that may predict failure, namely:\n\n* lymphopenia\n* thrombocytopenia\n* CRP\n* ferritin\n* LDH\n* troponin I\n* NT-ProBNP\n* Liver enzymes\n* D-dimers\n* radiologic aggravation " 1 day and 1 week after starting NIV or CPAP', 'armGroupLabels': ['CPAP', 'NIV']}, {'name': 'Evaluate HACOR score effectivity in this patients', 'type': 'OTHER', 'description': 'Apply the HACOR score after starting NIV and CPAP and later verify if it was effective in predicting NIV/CPAP failure', 'armGroupLabels': ['CPAP', 'NIV']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Murcia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Antonio Esquinas', 'role': 'CONTACT', 'email': 'antmesquinas@gmail.com', 'phone': '0034609321966'}], 'facility': 'Hospital General Universitario Morales Meseguer', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}], 'centralContacts': [{'name': 'Miguel Guia', 'role': 'CONTACT', 'email': 'miguelguia7@gmail.com', 'phone': '00351915774975'}, {'name': 'Antonio Esquinas', 'role': 'CONTACT', 'email': 'antmesquinas@gmail.com', 'phone': '0034609321966'}], 'overallOfficials': [{'name': 'Miguel Guia', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital General Universitario Morales Meseguer'}, {'name': 'Antonio Esquinas', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital General Universitario Morales Meseguer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital General Universitario Morales Meseguer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Miguel Filipe Martins de Matos Navarro Guia', 'investigatorAffiliation': 'Hospital General Universitario Morales Meseguer'}}}}