Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-31 @ 4:01 PM
Study NCT ID:
NCT04977960
Status:
UNKNOWN
Last Update Posted:
2022-05-20
First Post:
2021-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Canrenone as add-on Treatment in Moderate to Severe ARDS in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002191', 'term': 'Canrenoic Acid'}, {'id': 'D002192', 'term': 'Canrenone'}], 'ancestors': [{'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Open label, 1:1 randomized parallel arms, Simon's two stage design, single centre."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2021-07-21', 'studyFirstSubmitQcDate': '2021-07-22', 'lastUpdatePostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'in-hospital death', 'timeFrame': 'At the event (discharge or death)', 'description': 'patients discharged to a long-term care facility will be classified as "discharged alive"'}], 'secondaryOutcomes': [{'measure': 'Need of invasive mechanical ventilation throughout hospitalization', 'timeFrame': 'at discharge or death', 'description': 'Researchers will record if mechanical ventilation has been required during hospitalization (YES) or not (NO)'}, {'measure': 'Duration of hospitalization for alive patients', 'timeFrame': 'From date of randomization until the date discharge or in-hospital death from any cause, whichever came first, assessed up to 48 months', 'description': 'from randomization to discharge'}, {'measure': 'Drug intolerance', 'timeFrame': 'From the date of randomization until three days after the end of IMP administration (10 days after randomization)', 'description': 'measured as number of AR and SAR'}, {'measure': 'Number of hypotensive events', 'timeFrame': 'From the date of randomization until three days after the end of IMP administration (10 days after randomization)', 'description': 'defined as systolic blood pressure constantly \\<90 mmHg and diastolic blood pressure constantly \\<60 mmHg)'}, {'measure': 'Number of hyperkaliemias events', 'timeFrame': 'From the date of randomization until three days after the end of IMP administration (10 days after randomization)', 'description': 'defined as \\[K+\\]hematic \\>5.1 mEq/L'}, {'measure': 'Number of renal failures', 'timeFrame': 'From the date of randomization until three days after the end of IMP administration (10 days after randomization)', 'description': 'defined as eGFR \\<30 ml/min'}, {'measure': 'Change in Sequential Organ Failure Assessment (SOFA) score from randomization to 7 days after randomization', 'timeFrame': '7 days after randomization', 'description': 'A score from 0 (better outcome) to 4 (worst outcome) for six different systems (respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems) will be assessed and recorded in CRF'}, {'measure': 'Change in inflammatory status', 'timeFrame': 'at 48 hours and 168 hours (7th day) from randomization', 'description': 'CRP levels, IL-6, Ddimer and Ferritin'}, {'measure': 'Change in respiratory parameters', 'timeFrame': 'at 48 hours and 168 hours (7th day) from randomization', 'description': 'Heart Rate, Blood Pressure (mmHg), PaO2/FiO2 (mmHg), alveolar-arterial gradient (mmHg)'}, {'measure': 'Changes in features of pulmonary interstitial disease measured by chest X-Ray', 'timeFrame': 'at 7 days after randomization'}, {'measure': 'Changes in [K+]hematic, renin, AngII, Ang1-7, Ang1-9, aldosterone and structurally related steroids', 'timeFrame': 'at randomization and at 48 and 168 hours (7th day) from randomization', 'description': '\\[K+\\]hematic will be expressed as mEq/L Plasmatic Renin Activity will be expressed as µUI/mL Hematic Concentration of AngII, Ang1-7, Ang1-9, aldosterone and structurally related steroids will be expressed as ng/mL'}, {'measure': 'Correlation between levels of [K+]hematic, renin, AngII, Ang1-7, Ang1-9, aldosterone and structurally related steroids, at basal level (randomization) and clinical outcomes (in-hospital death, need of invasive mechanical ventilation, SOFA score)', 'timeFrame': 'at randomization and at 48 and 168 hours (7th day) from randomization', 'description': '\\[K+\\]hematic will be expressed as mEq/L Plasmatic Renin Activity will be expressed as µUI/mL Hematic Concentration of AngII, Ang1-7, Ang1-9, aldosterone and structurally related steroids will be expressed as ng/mL'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'potassium canrenoate'], 'conditions': ['COVID-19 Acute Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'The main aim of the study is to estimate the potential efficacy of i.v. canrenone as add-on therapy on maximal medical treatment versus maximal medical treatment alone in treating moderate-to-severe ARDS due to SARS-CoV-2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 - 80 y.o. Since over eighties are very fragile patients, a lot of confounding unpredictable events may interfere with the trial analyses; thus, these patients will be excluded from this exploratory proof-of-concept trial;\n* COVID-19 diagnosis through swab within 14 days from the beginning of symptoms\n* Hospitalization for moderate to severe ARDS (as determined by PaO2/FiO2 ≤300 mmHg at admission)\n* Serum concentration of potassium ≤4.5 mEq/L\n* Consent to participate\n\nExclusion Criteria:\n\n* Invasive mechanical ventilation\n* I.v. hydratation with Darrow's solution or half-strength Darrow's solution underway\n* Acute cardiovascular event (acute myocardial infarction, acute ischaemic stroke)\n* Current malignant disease\n* Creatinine \\>1.8 mg/dL (for women) and \\>2.0 mg/dL (for men) or glomerular filtration rate \\<50 mL/mm\n* Systolic blood pressure \\<110 mmHg and/or diastolic blood pressure \\<60 mmHg\n* Known or suspected hypersensitivity to canrenone\n* Hyponatremia\n* Anuria\n* Familial history of porphyria\n* Pregnancy and breastfeeding\n* known or suspected hypersensitivity to canrenone\n* Inclusion in any other pharmacological clinical trials"}, 'identificationModule': {'nctId': 'NCT04977960', 'acronym': 'MINECRAFT', 'briefTitle': 'Efficacy of Canrenone as add-on Treatment in Moderate to Severe ARDS in COVID-19', 'organization': {'class': 'OTHER', 'fullName': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}, 'officialTitle': 'MINECRAFT Study: MINEralcorticoid Receptor Antagonism With CanRenone As eFfective Treatment in Moderate to Severe ARDS in COVID-19, a Phase 2 Clinical Trial.', 'orgStudyIdInfo': {'id': 'MINECRAFT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Reference group', 'description': 'Patients randomized to the Reference Group will receive the standard-of-care treatments, according to institutional procedures in force:\n\n* Dexamethasone i.v. 6 mg die for consecutive 5 days\n* Methylprednisolone i.v. 40 mg bid for consecutive 10 days\n* Low-molecular-weight-heparin i.v. at standardized dose of 70 UI/kg twice\n* Remdesivir i.v. 200 mg in bolus (1st day) then 100 mg die for 4 days; remdesivir will be used only in patients supported with low-flow nasal cannula oxygen or Venturi mask\n* Antibiotic therapy:\n\n * azithromycin: 500 mg/die per os for 5 days\n * ceftriaxone: 2 g i.v. die for 8 days'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Patients randomized in the Experimental Group will receive canrenone as add-on therapy to standard-of-care treatments. Different starting doses of i.v. canrenone will be administrated in a single or double infusion per day, for 7 days, according to the serum concentration of potassium at randomization', 'interventionNames': ['Drug: Potassium Canrenoate']}], 'interventions': [{'name': 'Potassium Canrenoate', 'type': 'DRUG', 'otherNames': ['Canrenone'], 'description': 'potassium canrenoate for 7 days in addition to maximal medical treatment', 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marco Vicenzi, MD', 'role': 'CONTACT', 'email': 'marco.vicenzi@policlinico.mi.it', 'phone': '+390255033537'}], 'overallOfficials': [{'name': 'Marco Vicenzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Milan', 'class': 'OTHER'}, {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}