Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-27 @ 5:50 PM
Study NCT ID:
NCT04629703
Status:
COMPLETED
Last Update Posted:
2023-08-18
First Post:
2020-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Peru']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}], 'ancestors': [{'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': 'C523665', 'term': 'fostamatinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'dispFirstSubmitDate': '2023-08-15', 'completionDateStruct': {'date': '2022-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-15', 'studyFirstSubmitDate': '2020-11-13', 'studyFirstSubmitQcDate': '2020-11-13', 'dispFirstPostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of days on oxygen from randomization on Day 1 to Day 29', 'timeFrame': '29 days', 'description': 'Number of days on oxygen from randomization on Day 1 to Day 29'}], 'secondaryOutcomes': [{'measure': 'Mean change from baseline over time in clinical status score using the 8-point ordinal scale, to the average from Day 5 through Day 15.', 'timeFrame': '10 days', 'description': 'Mean change from baseline over time in clinical status score using the 8-point ordinal'}, {'measure': 'Number of days in the ICU from randomization on Day 1 to Day 29', 'timeFrame': '29 days', 'description': 'Number of days in the ICU from randomization on Day 1 to Day 29'}, {'measure': 'Time to first sustained hospital discharge by Day 29. (A discharge is defined as sustained when no readmission occurs by Day 29 after the discharge).', 'timeFrame': '29 days', 'description': 'Time to first sustained hospital discharge by Day 29. (A discharge is defined as sustained when no readmission occurs by Day 29 after the discharge).'}, {'measure': 'All-cause mortality by Day 29.', 'timeFrame': '29 days', 'description': 'All-cause mortality by Day 29.'}, {'measure': 'All-cause mortality by Day 60', 'timeFrame': '60 days', 'description': 'All-cause mortality by Day 60'}, {'measure': 'Proportion of subjects alive by Day 29 and oxygen free on Day 29.', 'timeFrame': '29 days', 'description': 'Proportion of subjects alive by Day 29 and oxygen free on Day 29.'}, {'measure': 'Proportion of subjects alive by Day 60 and oxygen free on Day 29', 'timeFrame': '60 days', 'description': 'Proportion of subjects alive by Day 60 and oxygen free on Day 29'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID19', 'SARS-Associated Coronavirus Pneumonia', 'Pneumonia, Viral'], 'conditions': ['Covid19', 'SARS (Severe Acute Respiratory Syndrome)', 'SARS Pneumonia', 'SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere', 'Pneumonia', 'Pneumonia, Viral']}, 'referencesModule': {'references': [{'pmid': '34473343', 'type': 'DERIVED', 'citation': 'Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The study is a double-blind, randomized, placebo-controlled, multi-center, Phase 3 study to evaluate the efficacy and safety of fostamatinib in COVID-19 subjects.', 'detailedDescription': 'The primary objective of this study is:\n\nTo evaluate the efficacy of fostamatinib when used in combination with standard of care (SOC) in subjects hospitalized with COVID- 19 and requiring oxygen supplementation, as measured by days on oxygen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years of age at screening.\n* The subject or a legally authorized representative has provided written informed consent.\n* Hospitalized COVID-19 subjects without respiratory failure who are either not receiving any oxygen therapy or are receiving supplemental oxygen via mask or nasal prongs.\n* Male or non-pregnant, non-lactating female subjects with SARS-CoV-2 infection documented by a hospital approved diagnostic test (eg, a Food and Drug Administration authorized test in the US) within 7 days prior to randomization.\n\nExclusion Criteria:\n\n* Pregnant or lactating female of childbearing potential.\n* Use of extracorporeal membrane oxygenation (ECMO).\n* Uncontrolled hypertension (systolic blood pressure \\[BP\\] ≥160 mmHg and/or diastolic BP ≥100 mmHg), unstable angina, congestive heart failure of New York Heart Association classification III or IV, serious cardiac arrhythmia requiring treatment at screening.\n* History of myocardial infarction within 1 month prior to screening.'}, 'identificationModule': {'nctId': 'NCT04629703', 'briefTitle': 'Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rigel Pharmaceuticals'}, 'officialTitle': 'Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects', 'orgStudyIdInfo': {'id': 'C-935788-061'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fostamatinib (150 mg twice daily for 14 days) + Standard of Care', 'description': 'Fostamatinib (150 mg twice daily for 14 days) + Standard of Care', 'interventionNames': ['Drug: Fostamatinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (twice daily for 14 days) + Standard of Care', 'description': 'Placebo (twice daily for 14 days) + Standard of Care', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Fostamatinib', 'type': 'DRUG', 'otherNames': ['Fostamatinib disodium'], 'description': 'Fostamatinib (150 mg twice daily) for 14 days and Standard of Care', 'armGroupLabels': ['Fostamatinib (150 mg twice daily for 14 days) + Standard of Care']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo (twice daily) for 14 days and Standard of Care', 'armGroupLabels': ['Placebo (twice daily for 14 days) + Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Alternative Research Associates, LLC', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Alternative Research Associates, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60600', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Medical School', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Harvard Medical School- Bringham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '74101', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Ascension Medical Group- St. John Clinic Infectious Disease', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Research Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'CP 1650', 'city': 'San Martín', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Corporacion Medica de General San Martin', 'geoPoint': {'lat': -35.02575, 'lon': -57.75317}}, {'zip': 'EPU5000', 'city': 'Córdoba', 'state': 'CP', 'country': 'Argentina', 'facility': 'Clinica Chutro', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': 'PC: 5547', 'city': 'Godoy Cruz', 'state': 'Mendoza Province', 'country': 'Argentina', 'facility': 'Hospital Lencinas', 'geoPoint': {'lat': -32.92533, 'lon': -68.84428}}, {'zip': 'B1814', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital de Alta Complejidad Cuenta Alta', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'B1842', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Del Bicentenario - Dr. Luis Federico Leloir', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1426', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Clinica Zabala', 'geoPoint': {'lat': -34.61315, 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