Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-01-06 @ 4:58 AM
Study NCT ID:
NCT04493359
Status:
TERMINATED
Last Update Posted:
2021-10-06
First Post:
2020-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Switch of Renin-Angiotensin System Inhibitors in Patients With Covid-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'Dificulteis in enrolling patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2020-07-29', 'studyFirstSubmitQcDate': '2020-07-29', 'lastUpdatePostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need for ICU or mortality', 'timeFrame': '30 days', 'description': 'Combined of need for ICU or mortality'}], 'secondaryOutcomes': [{'measure': 'High sensitivity troponin levels and covid-19 severity', 'timeFrame': '30 days', 'description': 'Evaluate correlation between hs-TnT and covid-19 severity'}, {'measure': 'ACE-2 activity and disease severity', 'timeFrame': '30 days', 'description': 'Evaluate correlation of ACE-2 activity and disease severity'}, {'measure': 'ACE-2 activity with different Renin-angiotensin system inhibitors', 'timeFrame': '30 days', 'description': 'Evaluate correlation of ACE-2 activity and Renin-angiotensin system inhibitors'}, {'measure': 'Blood control and acute renal failure', 'timeFrame': '30 days', 'description': 'Evaluate blood pressure control and acute renal failure in each arm (safety)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['covid19', 'ace inhibitors', 'ace2'], 'conditions': ['Covid19', 'Angiotensin II Receptor Antagonist Adverse Reaction']}, 'descriptionModule': {'briefSummary': 'The SWITCH-COVID trial will randomize patients with COVID-19 that are currently using renin-angiotensin system inhibitors for treating hypertension to maintain the therapy during in-hospital stay or switch the therapy to other antihypertensive classes.', 'detailedDescription': 'Patients eligible for the study, after signing informed consent will be randomized 1:1 for maintenance of renin-angiotensin system inhibitors or switching the antihypertensive therapy for other classes according to a pre-specified protocol.\n\nPatients are going to be followed during hospital stay for evaluation of clinical endpoints. Also blood and urine samples will be acquired for evaluation of renin-angiotensin system activation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hypertension in use of renin-angiotensin system inhibitors\n* Confirmed COVID-19 infection by rt-PCR, serology tests or typical clinical presentation and chest CT.\n* Symptoms onset \\< 96h\n* Need for hospitalization\n\nExclusion Criteria:\n\n* Heart failure\n* Previous cerebrovascular disease\n* Previous myocardial infarction\n* Blood pressure \\> 180 x 100 mmHg\n* Need for 3 or more anti-hypertensive classes\n* Use os spironolactone\n* Severe pulmonary disease\n* Contraindication for using other anti-hypertensive classes (calcium channel blockers, hydralazine, diuretics or nitrates)'}, 'identificationModule': {'nctId': 'NCT04493359', 'acronym': 'SWITCH-COVID', 'briefTitle': 'Switch of Renin-Angiotensin System Inhibitors in Patients With Covid-19', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Switch or Maintenance of Renin-Angiotensin System Inhibitors in Patients With Covid-19: A Randomized Proof of Concept Trial', 'orgStudyIdInfo': {'id': '33575220.9.0000.0068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Switch therapy', 'description': 'Renin-angiotensin system inhibitors will be changed for other anti-hypertensive classes.', 'interventionNames': ['Drug: Renin-angiotensin system inhibitors']}, {'type': 'NO_INTERVENTION', 'label': 'Maintenance therapy', 'description': 'Renin-angiotensin system inhibitors will be kept during in-hospital stay'}], 'interventions': [{'name': 'Renin-angiotensin system inhibitors', 'type': 'DRUG', 'description': 'switch anti-hypertensive class', 'armGroupLabels': ['Switch therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto do Coração - Incor HCFMUSP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data may be requested for collaboration projects'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD. PHD.', 'investigatorFullName': 'Bruno Caramelli', 'investigatorAffiliation': 'University of Sao Paulo'}}}}