Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-01-06 @ 1:14 AM
Study NCT ID:
NCT04686760
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2020-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Inhaled Nitroglycerin in Moderate to Critically Ill COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005996', 'term': 'Nitroglycerin'}], 'ancestors': [{'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 278}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2020-12-24', 'studyFirstSubmitQcDate': '2020-12-25', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ratio of partial pressure of oxygen in arterial blood to fraction of inhaled oxygen', 'timeFrame': '5-7 days'}, {'measure': 'Oxygen demand', 'timeFrame': '5-7 days'}], 'secondaryOutcomes': [{'measure': 'Duration of hospital stay', 'timeFrame': '15 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Corona Virus Infection']}, 'descriptionModule': {'briefSummary': 'In current analysis moderate to severely ill Covid-19 infected patients will be nebulized with nitroglycerin, and they will be compared with the standard nebulization'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDiagnosed admitted cases of Covid-19 degree of illness should be moderate to severe both male and female every age group\n\nExclusion Criteria:\n\nallergic to nitroglycerin sudden drop in blood pressure not given consent'}, 'identificationModule': {'nctId': 'NCT04686760', 'briefTitle': 'Efficacy of Inhaled Nitroglycerin in Moderate to Critically Ill COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Lahore'}, 'officialTitle': 'Efficacy of Inhaled Nitroglycerin in Moderate to Severe Cases of COVID-19 Patients', 'orgStudyIdInfo': {'id': 'IRBEC/BIH/08-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nitroglycerin solution', 'interventionNames': ['Drug: Nitroglycerin']}, {'type': 'NO_INTERVENTION', 'label': 'standard solution'}], 'interventions': [{'name': 'Nitroglycerin', 'type': 'DRUG', 'description': '2 mg/ml solution of nitroglycerin used for nebulization four hourly', 'armGroupLabels': ['Nitroglycerin solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Bahria Town International Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lahore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Muhammad Mansoor Hafeez', 'investigatorAffiliation': 'University of Lahore'}}}}