Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-25 @ 11:33 PM
Study NCT ID:
NCT04842292
Status:
TERMINATED
Last Update Posted:
2022-10-18
First Post:
2021-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nebulized Heparin for COVID19-associated Acute Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bdbi223@uky.edu', 'phone': '8593239308', 'title': 'Brittany Bissell', 'organization': 'University of Kentucky'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Participants', 'description': 'Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data for the two arms will be combined.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean PaO2/FiO2 Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants', 'description': 'Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Due to the possibility that individual participant data could be identified since there were only 2 participants, data cannot be presented without risking participant privacy.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within the first 10 days of ICU stay or up until ICU discharge, whichever occurs first', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.'}, {'type': 'SECONDARY', 'title': 'Clinically Significant Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants', 'description': 'Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data for the two arms will be combined.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Due to the possibility that individual participant data could be identified since there were only 2 participants, data cannot be presented without risking participant privacy.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to discharge or 3 months following enrollment, whichever occurs first', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.'}, {'type': 'SECONDARY', 'title': 'Incidence of Venous Thromboembolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants', 'description': 'Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data for the two arms will be combined.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Due to the possibility that individual participant data could be identified since there were only 2 participants, data cannot be presented without risking participant privacy.', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to discharge or 3 months following enrollment, whichever occurs first', 'unitOfMeasure': 'Incidence', 'reportingStatus': 'POSTED', 'populationDescription': 'Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants', 'description': 'Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data for the two arms will be combined.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Two participants were enrolled. To protect privacy, data will not be presented for each arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants', 'description': 'Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data for the two arms will be combined.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Two participants were enrolled.'}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2022-01-31', 'size': 6774292, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2022-10-17T14:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Lack of enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-17', 'studyFirstSubmitDate': '2021-04-08', 'resultsFirstSubmitDate': '2022-09-21', 'studyFirstSubmitQcDate': '2021-04-12', 'lastUpdatePostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-17', 'studyFirstPostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean PaO2/FiO2 Ratio', 'timeFrame': 'Within the first 10 days of ICU stay or up until ICU discharge, whichever occurs first'}], 'secondaryOutcomes': [{'measure': 'Clinically Significant Bleeding', 'timeFrame': 'Up to discharge or 3 months following enrollment, whichever occurs first'}, {'measure': 'Incidence of Venous Thromboembolism', 'timeFrame': 'Up to discharge or 3 months following enrollment, whichever occurs first'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'The objective of the current study is to investigate the utilization of nebulized heparin to circumvent pathologic changes in COVID-19 and prevent harmful effects possible with systemic anticoagulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients admitted with confirmed COVID-19 receiving mechanical ventilation for ARDS (paO2/FiO2 ratio =300) within 48 hours\n\nExclusion Criteria:\n\n* Allergy to heparin\n* Any history of heparin-induced thrombocytopenia\n* High risk of bleeding (platelet count \\< 50,000/µL or international normalized ratio \\> 1.5)\n* Patients with known bleeding disorders (i.e. hemophilia or von Willebrand Disease)\n* Active bleeding\n* Pulmonary bleeding during this hospital admission (Pulmonary bleeding is frank bleeding in the lungs, trachea or bronchi with repeated hemoptysis, or requiring repeated suctioning, and temporally associated with acute deterioration in respiratory status)\n* Neurosurgical procedures during this hospital admission or such procedures are planned\n* Epidural catheter in place\n* Any history of intracranial, spinal or epidural hemorrhage\n* Tracheostomy in place\n* Cervical spinal cord injury associated with reduced long-term ability to breathe independently\n* Spinal or peripheral nerve disease with a likely prolonged reduction in the ability to breathe independently\n* Receiving extra-corporeal membrane oxygenation or continuous renal replacement therapy\n* Usually treated with hemodialysis or peritoneal dialysis for end-stage renal failure\n* Death is deemed imminent or inevitable or there is an underlying disease with a life expectancy of fewer than 90 days\n* Pregnant or might be pregnant.\n* Objection from the treating clinician\n* Consent refused by the patient or substitute decision maker.\n* History of thrombosis (VTE or cardiovascular event)'}, 'identificationModule': {'nctId': 'NCT04842292', 'briefTitle': 'Nebulized Heparin for COVID19-associated Acute Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Utilization of Nebulized Heparin for Patients Receiving Mechanical Ventilation for COVID19-associated Acute Respiratory Failure', 'orgStudyIdInfo': {'id': '65139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nebulized heparin', 'description': 'Nebulized heparin 25,000 units in 3 mL inhalation every 6 hours', 'interventionNames': ['Drug: Heparin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Nebulized placebo', 'description': 'Sodium chloride 0.9% 5 mL inhalation every 6 hours', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Heparin', 'type': 'DRUG', 'description': 'Nebulized heparin 25,000 units every 6 hours', 'armGroupLabels': ['Nebulized heparin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sodium chloride 0.9% every 6 hours', 'armGroupLabels': ['Nebulized placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'UK Healthcare', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Brittany D Bissell', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brittany Bissell', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Brittany Bissell', 'investigatorAffiliation': 'University of Kentucky'}}}}