Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-31 @ 12:23 PM
Study NCT ID:
NCT05024006
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2021-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Public Health Emergency: SOLIDARITY TRIAL Philippines
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': 'C000606551', 'term': 'remdesivir'}, {'id': 'D006886', 'term': 'Hydroxychloroquine'}, {'id': 'D061466', 'term': 'Lopinavir'}, {'id': 'D000068556', 'term': 'Interferon beta-1a'}, {'id': 'C000604908', 'term': 'acalabrutinib'}], 'ancestors': [{'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D016899', 'term': 'Interferon-beta'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Adaptive design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1314}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-27', 'studyFirstSubmitDate': '2021-08-21', 'studyFirstSubmitQcDate': '2021-08-21', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': 'Number of days from hospital admission up to 28 days post discharge'}], 'secondaryOutcomes': [{'measure': 'Duration of hospital stay', 'timeFrame': 'Number of days from hospital admission to discharge up to 28 days post admission'}, {'measure': 'Time to first receiving ventilation', 'timeFrame': 'Number of days from hospital admission to day of receiving ventilatory support up to 28 days post admission'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Solidarity', 'Hydroxychloroquine', 'Lopinavir+Ritonavir', 'Interferon Beta 1a', 'Remdesivir'], 'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '36695483', 'type': 'DERIVED', 'citation': 'Grundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2.'}]}, 'descriptionModule': {'briefSummary': 'This study is an adaptive, randomized, open-label, controlled clinical trial utilizing an adaptive design to compare effects of repurposed drugs with local standard of care alone on major inpatient hospital outcomes. This is performed worldwide in collaboration with WHO.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consenting adults (age ≥18) hospitalised with the following criteria will be included in the study:\n\n 1. Probable or confirmed COVID-19 regardless of severity, i.e., mild, moderate and severe cases\n 2. Not already receiving any of the study drugs\n 3. Without known allergy or contraindications to any of the study drugs (in the view of the physician responsible for their care), and\n 4. Without anticipated transfer within 72 hours to a non-study hospital.\n\nExclusion Criteria:\n\n* Patients with contraindications to any of the study drugs.'}, 'identificationModule': {'nctId': 'NCT05024006', 'briefTitle': 'Public Health Emergency: SOLIDARITY TRIAL Philippines', 'organization': {'class': 'OTHER', 'fullName': 'University of the Philippines'}, 'officialTitle': 'An International Randomized Trial of Additional Treatments for COVID-19 in Hospitalized Patients Who Are All Receiving the Local Standard of Care Philippines', 'orgStudyIdInfo': {'id': 'SJREB-2020-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'LSoC', 'description': 'Local Standard of Care'}, {'type': 'EXPERIMENTAL', 'label': 'Rem+LSoC', 'description': 'Remdesivir with Local Standard of Care', 'interventionNames': ['Drug: Remdesivir']}, {'type': 'EXPERIMENTAL', 'label': 'HCQ+LSoC', 'description': 'Hydroxychloroquine with Local Standard of Care', 'interventionNames': ['Drug: Hydroxychloroquine']}, {'type': 'EXPERIMENTAL', 'label': 'Lopi/Rito+LSoC', 'description': 'Lopinavir/Ritonavir with Local Standard of Care', 'interventionNames': ['Drug: Lopinavir / Ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'Lopi/Rito+IFN+LSoC', 'description': 'Lopinavir/Ritonavir and Interferon Beta 1a with Local Standard of Care', 'interventionNames': ['Drug: Lopinavir / Ritonavir', 'Drug: Interferon beta-1a']}, {'type': 'EXPERIMENTAL', 'label': 'IFN+LSoC', 'description': 'Interferon Beta 1a with Local Standard of Care', 'interventionNames': ['Drug: Interferon beta-1a']}, {'type': 'EXPERIMENTAL', 'label': 'ACB+LSoC', 'description': 'Acalabrutinib with Local Standard of Care', 'interventionNames': ['Drug: Acalabrutinib']}], 'interventions': [{'name': 'Remdesivir', 'type': 'DRUG', 'description': 'Two intravenous loading doses, then daily infusion for 10 days', 'armGroupLabels': ['Rem+LSoC']}, {'name': 'Hydroxychloroquine', 'type': 'DRUG', 'description': 'Two oral loading doses, then orally twice daily for 10 days', 'armGroupLabels': ['HCQ+LSoC']}, {'name': 'Lopinavir / Ritonavir', 'type': 'DRUG', 'description': 'Orally twice daily for 14 days', 'armGroupLabels': ['Lopi/Rito+IFN+LSoC', 'Lopi/Rito+LSoC']}, {'name': 'Interferon beta-1a', 'type': 'DRUG', 'description': 'Daily injection for 6 days', 'armGroupLabels': ['IFN+LSoC', 'Lopi/Rito+IFN+LSoC']}, {'name': 'Acalabrutinib', 'type': 'DRUG', 'description': 'Orally twice daily for 10 days', 'armGroupLabels': ['ACB+LSoC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baguio City', 'state': 'Benguet', 'country': 'Philippines', 'facility': 'Baguio General Hospital', 'geoPoint': {'lat': 16.41639, 'lon': 120.59306}}, {'city': 'Cebu City', 'state': 'Cebu', 'country': 'Philippines', 'facility': "Cebu Doctor's University Hospital", 'geoPoint': {'lat': 10.31672, 'lon': 123.89071}}, {'city': 'Cebu City', 'state': 'Cebu', 'country': 'Philippines', 'facility': 'Perpetual Succor Hospital Cebu', 'geoPoint': {'lat': 10.31672, 'lon': 123.89071}}, {'city': 'Cebu City', 'state': 'Cebu', 'country': 'Philippines', 'facility': 'Vicente Sotto Memorial Medical Center', 'geoPoint': {'lat': 10.31672, 'lon': 123.89071}}, {'city': 'Davao City', 'state': 'Davao Region', 'country': 'Philippines', 'facility': 'Southern Philippines Medical Center', 'geoPoint': {'lat': 7.07306, 'lon': 125.61278}}, {'city': 'Iloilo City', 'state': 'Iloilo', 'country': 'Philippines', 'facility': 'West Visayas University Medical Center', 'geoPoint': {'lat': 10.69694, 'lon': 122.56444}}, {'city': 'City of Taguig', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': "St Luke's Medical Center Global", 'geoPoint': {'lat': 14.5243, 'lon': 121.0792}}, {'city': 'Makati City', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'Makati Medical Center', 'geoPoint': {'lat': 14.55027, 'lon': 121.03269}}, {'city': 'Manila', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'Chinese General Hospital', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Manila', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'Manila Doctors Hospital', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Manila', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'ManilaMed - Medical Center Philippines', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Manila', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'San Lazaro Hospital', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Manila', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'UP - Philippine General Hospital', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Muntinlupa', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'Asian Hospital and Medical Center'}, {'city': 'Muntinlupa', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'Research Institute for Tropical Medicine'}, {'city': 'Pasay', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'San Juan de Dios Educational Foundation Inc - Hospital', 'geoPoint': {'lat': 14.53748, 'lon': 121.00144}}, {'city': 'Pasig', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'The Medical City', 'geoPoint': {'lat': 14.58691, 'lon': 121.0614}}, {'city': 'Quezon City', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'Diliman Doctors Hospital', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'city': 'Quezon City', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'Fe Del Mundo Medical Center', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'city': 'Quezon City', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'Lung Center of the Philippines', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'city': 'Quezon City', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': "St Luke's Medical Center Quezon City", 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'city': 'Quezon City', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'University of the East Ramon Magsaysay Memorial Medical Center', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'city': 'Quezon City', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'World Citi Medical Center', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'city': 'San Juan City', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'Cardinal Santos Medical Center', 'geoPoint': {'lat': 14.6, 'lon': 121.0333}}, {'city': 'Batangas', 'country': 'Philippines', 'facility': 'Batangas Medical Center', 'geoPoint': {'lat': 13.7567, 'lon': 121.0584}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of the Philippines', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Marissa Alejandria MD', 'investigatorAffiliation': 'University of the Philippines'}}}}