Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT04579393
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2020-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fostamatinib for Hospitalized Adults With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}}}}, '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': 'C523665', 'term': 'fostamatinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeffrey.strich@nih.gov', 'phone': '301.496.9320', 'title': 'Jeffrey Strich, MD', 'organization': 'The National Institutes of Health / The National Heart, Lung, and Blood Institute'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '60 days', 'eventGroups': [{'id': 'EG000', 'title': 'Fostamatinib With Standard of Care for Treatment of COVID-19', 'description': 'Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 8, 'seriousNumAtRisk': 30, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Placebo With Standard of Care for Treatment of COVID-19', 'description': 'Placebo: Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 15, 'seriousNumAtRisk': 29, 'deathsNumAffected': 3, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}], 'seriousEvents': [{'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'ACUTE RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Self-Extubation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Post COVID Fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With at Least 1 Serious Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fostamatinib With Standard of Care for Treatment of COVID-19', 'description': 'Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}, {'id': 'OG001', 'title': 'Placebo With Standard of Care for Treatment of COVID-19', 'description': 'Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 29', 'description': 'Number of participants with at least 1 serious adverse event by day 29 using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE is a list of common adverse event (AE) terms. Each AE term is defined and accompanied by a grading scale (1 to 5) that indicates the severity of the AE. Grading ranges from Grade 1 which is mild to Grade 5 which is death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat analysis'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Sustained Recoveries Defined by Ordinal Scale Score of 3 or Less', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fostamatinib With Standard of Care for Treatment of COVID-19', 'description': 'Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}, {'id': 'OG001', 'title': 'Placebo With Standard of Care for Treatment of COVID-19', 'description': 'Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 29', 'description': 'Time to sustained recovery determined by ordinal scale score of 3 or less and defined as time to recovery \\[either discharge from the hospital or hospitalization for infection control reasons only\\], with the recovery status sustained through day 29.\n\nThe ordinal scale is an assessment of the clinical status. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Progress to Mechanical Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fostamatinib With Standard of Care for Treatment of COVID-19', 'description': 'Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}, {'id': 'OG001', 'title': 'Placebo With Standard of Care for Treatment of COVID-19', 'description': 'Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 29', 'description': 'Number of participants who progress to mechanical ventilation by day 29', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were not receiving mechanical ventilation at baseline'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cumulative Clinical Endpoint of Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fostamatinib With Standard of Care for Treatment of COVID-19', 'description': 'Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}, {'id': 'OG001', 'title': 'Placebo With Standard of Care for Treatment of COVID-19', 'description': 'Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}], 'classes': [{'title': 'day 14', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'day 28', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'day 60', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 14, day 28, day 60', 'description': 'Number of Participants with Cumulative Clinical Endpoint of Death at Day 14, Day 28 and Day 60', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat analysis'}, {'type': 'SECONDARY', 'title': 'Number of Grade 3 and 4 Adverse Events Through Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fostamatinib With Standard of Care for Treatment of COVID-19', 'description': 'Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}, {'id': 'OG001', 'title': 'Placebo With Standard of Care for Treatment of COVID-19', 'description': 'Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}], 'classes': [{'title': 'Grade 3', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 60', 'description': 'Number of Grade 3 and 4 AE through day 60 using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE is a list of common adverse event (AE) terms. Each AE term is defined and accompanied by a grading scale (1 to 5) that indicates the severity of the AE. Grading ranges from Grade 1 which is mild to Grade 5 which is death.', 'unitOfMeasure': 'Adverse Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat analysis'}, {'type': 'SECONDARY', 'title': 'Participant Score on Ordinal Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fostamatinib With Standard of Care for Treatment of COVID-19', 'description': 'Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}, {'id': 'OG001', 'title': 'Placebo With Standard of Care for Treatment of COVID-19', 'description': 'Placebo: Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}], 'classes': [{'title': 'Day 15', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 15, Day 29', 'description': 'Participant score on ordinal scale at day 15 and day 29. The ordinal scale is an assessment of the clinical status. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'intent to treat analysis'}, {'type': 'SECONDARY', 'title': 'Change in C-Reactive Protein Levels From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fostamatinib With Standard of Care for Treatment of COVID-19', 'description': 'Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}, {'id': 'OG001', 'title': 'Placebo With Standard of Care for Treatment of COVID-19', 'description': 'Placebo: Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '-37', 'groupId': 'OG000', 'lowerLimit': '-94', 'upperLimit': '-6'}, {'value': '-46', 'groupId': 'OG001', 'lowerLimit': '-105', 'upperLimit': '-1'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '-34', 'groupId': 'OG000', 'lowerLimit': '-84', 'upperLimit': '5'}, {'value': '-51', 'groupId': 'OG001', 'lowerLimit': '-128', 'upperLimit': '-23'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '-56', 'groupId': 'OG000', 'lowerLimit': '-108', 'upperLimit': '-17'}, {'value': '-66', 'groupId': 'OG001', 'lowerLimit': '-118', 'upperLimit': '-39'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '-52', 'groupId': 'OG000', 'lowerLimit': '-114', 'upperLimit': '-29'}, {'value': '-68', 'groupId': 'OG001', 'lowerLimit': '-139', 'upperLimit': '-46'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '-43', 'groupId': 'OG000', 'lowerLimit': '-109', 'upperLimit': '-33'}, {'value': '-71', 'groupId': 'OG001', 'lowerLimit': '-126', 'upperLimit': '-47'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '-65', 'groupId': 'OG000', 'lowerLimit': '-117', 'upperLimit': '-33'}, {'value': '-106', 'groupId': 'OG001', 'lowerLimit': '-155', 'upperLimit': '-57'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 3, Day 5, Day 8, Day 11, Day 15, Day 29', 'description': 'Change in C-Reactive Protein (CRP) blood levels from baseline. The upper limit of normal is 5 mg/L (milligrams per liter).', 'unitOfMeasure': 'mg/L (milligrams per liter)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.'}, {'type': 'SECONDARY', 'title': 'Change in Fibrinogen Levels From Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fostamatinib With Standard of Care for Treatment of COVID-19', 'description': 'Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}, {'id': 'OG001', 'title': 'Placebo With Standard of Care for Treatment of COVID-19', 'description': 'Placebo: Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '-60', 'groupId': 'OG000', 'lowerLimit': '-177', 'upperLimit': '-11'}, {'value': '-65', 'groupId': 'OG001', 'lowerLimit': '-155', 'upperLimit': '41'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '-86', 'groupId': 'OG000', 'lowerLimit': '-187', 'upperLimit': '2'}, {'value': '-78', 'groupId': 'OG001', 'lowerLimit': '-245', 'upperLimit': '36'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '-130', 'groupId': 'OG000', 'lowerLimit': '-260', 'upperLimit': '-34'}, {'value': '-96', 'groupId': 'OG001', 'lowerLimit': '-236', 'upperLimit': '-40'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '-141', 'groupId': 'OG000', 'lowerLimit': '-277', 'upperLimit': '-77'}, {'value': '-138', 'groupId': 'OG001', 'lowerLimit': '-250', 'upperLimit': '-14'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '-132', 'groupId': 'OG000', 'lowerLimit': '-182', 'upperLimit': '-24'}, {'value': '-76', 'groupId': 'OG001', 'lowerLimit': '-214', 'upperLimit': '10'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '-113', 'groupId': 'OG000', 'lowerLimit': '-235', 'upperLimit': '-63'}, {'value': '-231', 'groupId': 'OG001', 'lowerLimit': '-351', 'upperLimit': '-64'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 3, Day 5, Day 8, Day 11, Day 15, Day 29', 'description': 'Change in Fibrinogen blood levels from baseline. The upper limit of normal is Fibrinogen 466 milligrams per decilitre (mg/dL).', 'unitOfMeasure': 'mg/dL (milligrams per decilitre)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.'}, {'type': 'SECONDARY', 'title': 'Change in D-Dimer Levels From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fostamatinib With Standard of Care for Treatment of COVID-19', 'description': 'Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}, {'id': 'OG001', 'title': 'Placebo With Standard of Care for Treatment of COVID-19', 'description': 'Placebo: Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '-0.01', 'groupId': 'OG000', 'lowerLimit': '-0.19', 'upperLimit': '0.25'}, {'value': '-0.08', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '0.31'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '-0.06', 'groupId': 'OG000', 'lowerLimit': '-0.24', 'upperLimit': '0.11'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.74', 'upperLimit': '0.15'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '-0.15', 'groupId': 'OG000', 'lowerLimit': '-0.74', 'upperLimit': '0.07'}, {'value': '-0.24', 'groupId': 'OG001', 'lowerLimit': '-1.25', 'upperLimit': '0.1'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '-0.11', 'groupId': 'OG000', 'lowerLimit': '-0.56', 'upperLimit': '0.12'}, {'value': '-0.43', 'groupId': 'OG001', 'lowerLimit': '-0.99', 'upperLimit': '0.06'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '-0.06', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.12'}, {'value': '-0.32', 'groupId': 'OG001', 'lowerLimit': '-1.02', 'upperLimit': '0'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '-0.15', 'groupId': 'OG000', 'lowerLimit': '-0.31', 'upperLimit': '0'}, {'value': '-0.16', 'groupId': 'OG001', 'lowerLimit': '-0.82', 'upperLimit': '0.46'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 3, Day 5, Day 8, Day 11, Day 15, Day 29', 'description': 'Change in D-Dimer blood levels from baseline. The upper limit of normal is 0.50 mcg/mL (microgram per milliliter).', 'unitOfMeasure': 'mcg/mL (microgram per milliliter)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.'}, {'type': 'SECONDARY', 'title': 'Change in Ferritin Levels From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fostamatinib With Standard of Care for Treatment of COVID-19', 'description': 'Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}, {'id': 'OG001', 'title': 'Placebo With Standard of Care for Treatment of COVID-19', 'description': 'Placebo: Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '-94', 'groupId': 'OG000', 'lowerLimit': '-306', 'upperLimit': '20'}, {'value': '-190', 'groupId': 'OG001', 'lowerLimit': '-622', 'upperLimit': '-102'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '-213', 'groupId': 'OG000', 'lowerLimit': '-532', 'upperLimit': '-25'}, {'value': '-199', 'groupId': 'OG001', 'lowerLimit': '-684', 'upperLimit': '16'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '-73', 'groupId': 'OG000', 'lowerLimit': '-428', 'upperLimit': '438'}, {'value': '-253', 'groupId': 'OG001', 'lowerLimit': '-586', 'upperLimit': '-17'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '-169', 'groupId': 'OG000', 'lowerLimit': '-853', 'upperLimit': '93'}, {'value': '-491', 'groupId': 'OG001', 'lowerLimit': '-756', 'upperLimit': '-239'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '-346', 'groupId': 'OG000', 'lowerLimit': '-904', 'upperLimit': '4'}, {'value': '-561', 'groupId': 'OG001', 'lowerLimit': '-882', 'upperLimit': '-350'}]}]}, {'title': 'D29', 'categories': [{'measurements': [{'value': '-578', 'groupId': 'OG000', 'lowerLimit': '-1038', 'upperLimit': '-206'}, {'value': '-738', 'groupId': 'OG001', 'lowerLimit': '-1562', 'upperLimit': '-530'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 3, Day 5, Day 8, Day 11, Day 15, Day 29', 'description': 'Change in Ferritin levels from baseline. The upper limit of normal for Ferritin is 400 mcg/L (micrograms per liter).', 'unitOfMeasure': 'mcg/L (micrograms per liter)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.'}, {'type': 'SECONDARY', 'title': 'Change in Interleukin 6 (IL6) Levels From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fostamatinib With Standard of Care for Treatment of COVID-19', 'description': 'Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}, {'id': 'OG001', 'title': 'Placebo With Standard of Care for Treatment of COVID-19', 'description': 'Placebo: Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-11.5', 'upperLimit': '1.4'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '-2.6', 'upperLimit': '6.9'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-16.1', 'upperLimit': '4.4'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '-1.8', 'upperLimit': '4.5'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-5.5', 'upperLimit': '3.8'}, {'value': '-2.5', 'groupId': 'OG001', 'lowerLimit': '-6.6', 'upperLimit': '0'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-9.9', 'upperLimit': '1.4'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-8.2', 'upperLimit': '0.3'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-5.5', 'upperLimit': '1'}, {'value': '-0.7', 'groupId': 'OG001', 'lowerLimit': '-4.3', 'upperLimit': '0.5'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '-1.4', 'groupId': 'OG000', 'lowerLimit': '-6.5', 'upperLimit': '-0.4'}, {'value': '-1.4', 'groupId': 'OG001', 'lowerLimit': '-4', 'upperLimit': '-0.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 3, Day 5, Day 8, Day 11, Day 15, Day 29', 'description': 'Change in Interleukin 6 (IL6) blood levels from baseline. The upper limit of normal for IL6 is 1.8 picograms per milliliter (pg/mL).', 'unitOfMeasure': 'pg/mL (picograms per milliliter)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.'}, {'type': 'SECONDARY', 'title': 'Median Days Participants Were Admitted to Intensive Care Unit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fostamatinib With Standard of Care for Treatment of COVID-19', 'description': 'Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}, {'id': 'OG001', 'title': 'Placebo With Standard of Care for Treatment of COVID-19', 'description': 'Placebo: Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 29', 'description': 'Median days participants were admitted to Intensive Care Unit (ICU) by day 29', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants admitted to Intensive Care Unit'}, {'type': 'SECONDARY', 'title': 'Relative Change in SpO2/FiO2 Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fostamatinib With Standard of Care for Treatment of COVID-19', 'description': 'Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}, {'id': 'OG001', 'title': 'Placebo With Standard of Care for Treatment of COVID-19', 'description': 'Placebo: Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '0.97'}, {'value': '0.93', 'groupId': 'OG001', 'lowerLimit': '0.65', 'upperLimit': '1.04'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '1.09', 'groupId': 'OG000', 'lowerLimit': '0.75', 'upperLimit': '1.33'}, {'value': '0.88', 'groupId': 'OG001', 'lowerLimit': '0.76', 'upperLimit': '1.08'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '0.75', 'groupId': 'OG000', 'lowerLimit': '0.59', 'upperLimit': '1.83'}, {'value': '1.09', 'groupId': 'OG001', 'lowerLimit': '0.59', 'upperLimit': '1.39'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '1.49', 'groupId': 'OG000', 'lowerLimit': '0.81', 'upperLimit': '2.14'}, {'value': '0.99', 'groupId': 'OG001', 'lowerLimit': '0.53', 'upperLimit': '1.59'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '1.23', 'groupId': 'OG000', 'lowerLimit': '0.87', 'upperLimit': '1.5'}, {'value': '1.07', 'groupId': 'OG001', 'lowerLimit': '0.67', 'upperLimit': '1.79'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '0.74', 'groupId': 'OG000', 'lowerLimit': '0.74', 'upperLimit': '0.74'}, {'value': '0.49', 'groupId': 'OG001', 'lowerLimit': '0.42', 'upperLimit': '0.97'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 3, Day 5, Day 8, Day 11, Day 15, Day 29', 'description': 'Relative change in PaO2/FiO2 or SpO2/FiO2 ratio.', 'unitOfMeasure': 'SpO2/FiO2 ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only SpO2/FiO2 ratio is available as PaO2 was not consistently measured. Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.'}, {'type': 'SECONDARY', 'title': 'Change in SOFA Score From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fostamatinib With Standard of Care for Treatment of COVID-19', 'description': 'Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}, {'id': 'OG001', 'title': 'Placebo With Standard of Care for Treatment of COVID-19', 'description': 'Placebo: Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '0'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '0'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '2'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 3, Day 5, Day 8, Day 11, Day 15, Day 29', 'description': 'Change in SOFA score from baseline (day 1). The Sequential Organ Failure Assessment (SOFA) Score is a mortality prediction score that is based on the degree of dysfunction of six organ systems. The score is calculated on admission and every 24 hours until discharge using the worst parameters measured during the prior 24 hours. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). The "worst" measurement was defined as the measure that correlated to the highest number of points. The SOFA score ranges from 0 to 24.', 'unitOfMeasure': 'score on a SOFA scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.'}, {'type': 'SECONDARY', 'title': 'Median Days on Participants Received Supplemental Oxygen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fostamatinib With Standard of Care for Treatment of COVID-19', 'description': 'Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}, {'id': 'OG001', 'title': 'Placebo With Standard of Care for Treatment of COVID-19', 'description': 'Placebo: Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '10'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '27'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'day 29', 'description': 'Median days on participants received supplemental oxygen through day 29', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of Participants That Experienced Acute Renal Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fostamatinib With Standard of Care for Treatment of COVID-19', 'description': 'Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}, {'id': 'OG001', 'title': 'Placebo With Standard of Care for Treatment of COVID-19', 'description': 'Placebo: Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 29', 'description': 'The number of participants that experienced acute renal failure by day 29.\n\nAcute renal failure defined as increase in serum creatinine by ≥0.3mg/dL within 48 hours or increase in serum creatinine by ≥1.5 times baseline which is known or presumed to have occurred within the prior seven days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Experienced a Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fostamatinib With Standard of Care for Treatment of COVID-19', 'description': 'Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}, {'id': 'OG001', 'title': 'Placebo With Standard of Care for Treatment of COVID-19', 'description': 'Placebo: Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 29', 'description': 'Number of participants that experienced a deep vein thrombosis (DVT) or pulmonary embolism (PE) by day 29', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Absolute Lymphocyte Count Levels From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fostamatinib With Standard of Care for Treatment of COVID-19', 'description': 'Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}, {'id': 'OG001', 'title': 'Placebo With Standard of Care for Treatment of COVID-19', 'description': 'Placebo: Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '0.43', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.64'}, {'value': '0.13', 'groupId': 'OG001', 'lowerLimit': '-0.18', 'upperLimit': '0.42'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '0.48', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '1.03'}, {'value': '0.38', 'groupId': 'OG001', 'lowerLimit': '-0.14', 'upperLimit': '0.73'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '0.41', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '1.22'}, {'value': '0.34', 'groupId': 'OG001', 'lowerLimit': '-0.02', 'upperLimit': '1.09'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '1.37'}, {'value': '1.02', 'groupId': 'OG001', 'lowerLimit': '0.57', 'upperLimit': '1.44'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.52', 'upperLimit': '1.18'}, {'value': '0.68', 'groupId': 'OG001', 'lowerLimit': '0.25', 'upperLimit': '1.07'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '0.56', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '0.89'}, {'value': '0.81', 'groupId': 'OG001', 'lowerLimit': '0.42', 'upperLimit': '1.38'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 3, Day 5, Day 8, Day 11, Day 15, Day 29', 'description': 'Change in Absolute lymphocyte count blood levels from baseline.', 'unitOfMeasure': 'thousand cells per microliter', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.'}, {'type': 'SECONDARY', 'title': 'Change in Absolute Neutrophil Count Levels From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fostamatinib With Standard of Care for Treatment of COVID-19', 'description': 'Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}, {'id': 'OG001', 'title': 'Placebo With Standard of Care for Treatment of COVID-19', 'description': 'Placebo: Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '-1.22', 'upperLimit': '1.06'}, {'value': '-0.09', 'groupId': 'OG001', 'lowerLimit': '-2.06', 'upperLimit': '1.88'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '1.53', 'groupId': 'OG000', 'lowerLimit': '-2.31', 'upperLimit': '2.5'}, {'value': '0.94', 'groupId': 'OG001', 'lowerLimit': '-0.97', 'upperLimit': '2.1'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '0.63', 'groupId': 'OG000', 'lowerLimit': '-3.4', 'upperLimit': '3.78'}, {'value': '2.74', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '6.26'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '-0.95', 'groupId': 'OG000', 'lowerLimit': '-2.34', 'upperLimit': '1.1'}, {'value': '0.85', 'groupId': 'OG001', 'lowerLimit': '-1.42', 'upperLimit': '2.6'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '-1.77', 'groupId': 'OG000', 'lowerLimit': '-3.41', 'upperLimit': '-0.6'}, {'value': '-1.6', 'groupId': 'OG001', 'lowerLimit': '-5.22', 'upperLimit': '1.61'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '-2.54', 'groupId': 'OG000', 'lowerLimit': '-4.62', 'upperLimit': '-1.12'}, {'value': '-2.89', 'groupId': 'OG001', 'lowerLimit': '-7.9', 'upperLimit': '-0.22'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 3, Day 5, Day 8, Day 11, Day 15, Day 29', 'description': 'Change in Absolute neutrophil count blood levels from baseline.', 'unitOfMeasure': 'thousand cells per microliter', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.'}, {'type': 'SECONDARY', 'title': 'Change in Platelet Count Levels From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fostamatinib With Standard of Care for Treatment of COVID-19', 'description': 'Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}, {'id': 'OG001', 'title': 'Placebo With Standard of Care for Treatment of COVID-19', 'description': 'Placebo: Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '117'}, {'value': '58', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '103'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '150'}, {'value': '63', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '142'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '217'}, {'value': '62', 'groupId': 'OG001', 'lowerLimit': '-34', 'upperLimit': '171'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '156'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '-132', 'upperLimit': '128'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '-30', 'upperLimit': '92'}, {'value': '-26', 'groupId': 'OG001', 'lowerLimit': '-198', 'upperLimit': '26'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '-29', 'groupId': 'OG000', 'lowerLimit': '-87', 'upperLimit': '42'}, {'value': '-7', 'groupId': 'OG001', 'lowerLimit': '-102', 'upperLimit': '60'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 3, Day 5, Day 8, Day 11, Day 15, Day 29', 'description': 'Change in Platelet count blood levels from baseline.', 'unitOfMeasure': 'thousand cells per microliter', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fostamatinib With Standard of Care for Treatment of COVID-19', 'description': 'Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}, {'id': 'FG001', 'title': 'Placebo With Standard of Care for Treatment of COVID-19', 'description': 'Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants were enrolled from October 8, 2020, through March 2, 2021 across 2 centers: Inova Fairfax Hospital (Falls Church, VA) and the National Institutes of Health (NIH) Clinical Center (Bethesda, MD).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fostamatinib With Standard of Care for Treatment of COVID-19', 'description': 'Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}, {'id': 'BG001', 'title': 'Placebo With Standard of Care for Treatment of COVID-19', 'description': 'Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.3', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '57.0', 'spread': '14.1', 'groupId': 'BG001'}, {'value': '55.6', 'spread': '13.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Score on Ordinal Scale', 'classes': [{'categories': [{'title': 'Requiring supplemental oxygen', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Noninvasive ventilation or high-flow oxygen devices', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Invasive mechanical ventilation or extracorporeal membrane oxygen', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.', 'unitOfMeasure': 'Participants'}, {'title': 'Medication for COVID-19 other than the study drug', 'classes': [{'title': 'Remdesivir', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': 'Dexamethasone or other steroids (methylprednisolone and prednisone)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': 'Convalescent plasma or monoclonal antibodies', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-17', 'size': 641340, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-03T16:14', 'hasProtocol': True}, {'date': '2021-02-05', 'size': 595778, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-05-12T13:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-28', 'studyFirstSubmitDate': '2020-10-06', 'resultsFirstSubmitDate': '2022-02-14', 'studyFirstSubmitQcDate': '2020-10-06', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-28', 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With at Least 1 Serious Adverse Event', 'timeFrame': 'Day 29', 'description': 'Number of participants with at least 1 serious adverse event by day 29 using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE is a list of common adverse event (AE) terms. Each AE term is defined and accompanied by a grading scale (1 to 5) that indicates the severity of the AE. Grading ranges from Grade 1 which is mild to Grade 5 which is death.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Sustained Recoveries Defined by Ordinal Scale Score of 3 or Less', 'timeFrame': 'day 29', 'description': 'Time to sustained recovery determined by ordinal scale score of 3 or less and defined as time to recovery \\[either discharge from the hospital or hospitalization for infection control reasons only\\], with the recovery status sustained through day 29.\n\nThe ordinal scale is an assessment of the clinical status. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.'}, {'measure': 'Number of Participants Who Progress to Mechanical Ventilation', 'timeFrame': 'day 29', 'description': 'Number of participants who progress to mechanical ventilation by day 29'}, {'measure': 'Number of Participants With Cumulative Clinical Endpoint of Death', 'timeFrame': 'day 14, day 28, day 60', 'description': 'Number of Participants with Cumulative Clinical Endpoint of Death at Day 14, Day 28 and Day 60'}, {'measure': 'Number of Grade 3 and 4 Adverse Events Through Day 60', 'timeFrame': 'Day 60', 'description': 'Number of Grade 3 and 4 AE through day 60 using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE is a list of common adverse event (AE) terms. Each AE term is defined and accompanied by a grading scale (1 to 5) that indicates the severity of the AE. Grading ranges from Grade 1 which is mild to Grade 5 which is death.'}, {'measure': 'Participant Score on Ordinal Scale', 'timeFrame': 'Day 15, Day 29', 'description': 'Participant score on ordinal scale at day 15 and day 29. The ordinal scale is an assessment of the clinical status. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.'}, {'measure': 'Change in C-Reactive Protein Levels From Baseline', 'timeFrame': 'Day 3, Day 5, Day 8, Day 11, Day 15, Day 29', 'description': 'Change in C-Reactive Protein (CRP) blood levels from baseline. The upper limit of normal is 5 mg/L (milligrams per liter).'}, {'measure': 'Change in Fibrinogen Levels From Baseline.', 'timeFrame': 'Day 3, Day 5, Day 8, Day 11, Day 15, Day 29', 'description': 'Change in Fibrinogen blood levels from baseline. The upper limit of normal is Fibrinogen 466 milligrams per decilitre (mg/dL).'}, {'measure': 'Change in D-Dimer Levels From Baseline', 'timeFrame': 'Day 3, Day 5, Day 8, Day 11, Day 15, Day 29', 'description': 'Change in D-Dimer blood levels from baseline. The upper limit of normal is 0.50 mcg/mL (microgram per milliliter).'}, {'measure': 'Change in Ferritin Levels From Baseline', 'timeFrame': 'Day 3, Day 5, Day 8, Day 11, Day 15, Day 29', 'description': 'Change in Ferritin levels from baseline. The upper limit of normal for Ferritin is 400 mcg/L (micrograms per liter).'}, {'measure': 'Change in Interleukin 6 (IL6) Levels From Baseline', 'timeFrame': 'Day 3, Day 5, Day 8, Day 11, Day 15, Day 29', 'description': 'Change in Interleukin 6 (IL6) blood levels from baseline. The upper limit of normal for IL6 is 1.8 picograms per milliliter (pg/mL).'}, {'measure': 'Median Days Participants Were Admitted to Intensive Care Unit', 'timeFrame': 'Day 29', 'description': 'Median days participants were admitted to Intensive Care Unit (ICU) by day 29'}, {'measure': 'Relative Change in SpO2/FiO2 Ratio', 'timeFrame': 'Day 3, Day 5, Day 8, Day 11, Day 15, Day 29', 'description': 'Relative change in PaO2/FiO2 or SpO2/FiO2 ratio.'}, {'measure': 'Change in SOFA Score From Baseline', 'timeFrame': 'Day 3, Day 5, Day 8, Day 11, Day 15, Day 29', 'description': 'Change in SOFA score from baseline (day 1). The Sequential Organ Failure Assessment (SOFA) Score is a mortality prediction score that is based on the degree of dysfunction of six organ systems. The score is calculated on admission and every 24 hours until discharge using the worst parameters measured during the prior 24 hours. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). The "worst" measurement was defined as the measure that correlated to the highest number of points. The SOFA score ranges from 0 to 24.'}, {'measure': 'Median Days on Participants Received Supplemental Oxygen', 'timeFrame': 'day 29', 'description': 'Median days on participants received supplemental oxygen through day 29'}, {'measure': 'The Number of Participants That Experienced Acute Renal Failure', 'timeFrame': 'day 29', 'description': 'The number of participants that experienced acute renal failure by day 29.\n\nAcute renal failure defined as increase in serum creatinine by ≥0.3mg/dL within 48 hours or increase in serum creatinine by ≥1.5 times baseline which is known or presumed to have occurred within the prior seven days.'}, {'measure': 'Number of Participants That Experienced a Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)', 'timeFrame': 'day 29', 'description': 'Number of participants that experienced a deep vein thrombosis (DVT) or pulmonary embolism (PE) by day 29'}, {'measure': 'Change in Absolute Lymphocyte Count Levels From Baseline', 'timeFrame': 'Day 3, Day 5, Day 8, Day 11, Day 15, Day 29', 'description': 'Change in Absolute lymphocyte count blood levels from baseline.'}, {'measure': 'Change in Absolute Neutrophil Count Levels From Baseline', 'timeFrame': 'Day 3, Day 5, Day 8, Day 11, Day 15, Day 29', 'description': 'Change in Absolute neutrophil count blood levels from baseline.'}, {'measure': 'Change in Platelet Count Levels From Baseline', 'timeFrame': 'Day 3, Day 5, Day 8, Day 11, Day 15, Day 29', 'description': 'Change in Platelet count blood levels from baseline.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'Cytokines', 'Spleen Tyrosine Kinase', 'ARDS'], 'conditions': ['Coronavirus Disease 2019']}, 'referencesModule': {'references': [{'pmid': '34467402', 'type': 'DERIVED', 'citation': 'Strich JR, Tian X, Samour M, King CS, Shlobin O, Reger R, Cohen J, Ahmad K, Brown AW, Khangoora V, Aryal S, Migdady Y, Kyte JJ, Joo J, Hays R, Collins AC, Battle E, Valdez J, Rivero J, Kim IH, Erb-Alvarez J, Shalhoub R, Chakraborty M, Wong S, Colton B, Ramos-Benitez MJ, Warner S, Chertow DS, Olivier KN, Aue G, Davey RT, Suffredini AF, Childs RW, Nathan SD. Fostamatinib for the Treatment of Hospitalized Adults With Coronavirus Disease 2019: A Randomized Trial. Clin Infect Dis. 2022 Aug 24;75(1):e491-e498. doi: 10.1093/cid/ciab732.'}, {'pmid': '33367731', 'type': 'DERIVED', 'citation': 'Strich JR, Ramos-Benitez MJ, Randazzo D, Stein SR, Babyak A, Davey RT, Suffredini AF, Childs RW, Chertow DS. Fostamatinib Inhibits Neutrophils Extracellular Traps Induced by COVID-19 Patient Plasma: A Potential Therapeutic. J Infect Dis. 2021 Mar 29;223(6):981-984. doi: 10.1093/infdis/jiaa789.'}], 'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_000110-H.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nCOVID-19 is a new disease caused by SARS-CoV-2 that was identified in 2019. Some people who get sick with COVID-19 become ill requiring hospitalization. There are some medicines that may help with recovery. Researchers want to see if a drug called fostamatinib may help people who are hospitalized with COVID-19.\n\nObjective:\n\nTo learn if fostamatinib is safe in patients who are hospitalized with COVID-19 and gain earlier insight into whether it improves outcomes.\n\nEligibility:\n\nAdults age 18 and older who are hospitalized with COVID-19.\n\nDesign:\n\nParticipants will be screened with a physical exam, including vital signs and weight. They will have a blood test and chest x-ray. They will have a COVID-19 test as a swab of either the back of the throat or the back of the nose. They will take a pregnancy test if needed.\n\nParticipants will be randomly assigned, to take either fostamatinib pills or a placebo twice daily for up to 14 days in addition to standard of care for COVID-19. If they can swallow, they will take the pills by mouth with water. If they cannot swallow or are on mechanical ventilation, the pills will be crushed, mixed with water, and given through a tube placed through the nostril, or placed in the mouth, down the esophagus, and into the stomach. Blood samples will be taken daily. Participants will return to the Clinical Center for safety follow-up visits. At these visits, they will have a physical exam and blood tests. If they cannot visit the Clinical Center, they will be contacted by phone or have a telehealth visit.\n\nParticipation will last for about two months', 'detailedDescription': 'Coronavirus Disease 2019 (COVID-19) is the disease caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). SARS-CoV-2 primarily infects the upper and lower respiratory tract and can lead to acute respiratory distress syndrome (ARDS) in a subset of patients with a known high mortality rate. Additionally, some patients develop other organ dysfunction including myocardial injury, acute kidney injury, shock along with endothelial dysfunction and subsequently micro and macrovascular thrombosis.\n\nMuch of the underlying pathology of SARS-CoV-2 is thought to be secondary to a dysregulated immune response and more recently a hypercoagulable state leading to immunothrombosis. Currently, two therapies have shown efficacy in large multicenter trials for the treatment of COVID-19, one of which is an antiviral (remdesivir) and the other is an immunosuppressant corticosteroid meant to dampen the immune response (dexamethasone).\n\nSpleen tyrosine kinase (SYK) is a cytoplasmic tyrosine kinase involved in the intracellular signaling pathways of many different immune cells. In this pilot study we propose to use fostamatinib (an SYK inhibitor) as a targeted therapy for the immunological complications of hospitalized patients with COVID-19. The biological mechanisms by which SYK inhibition may improve outcomes in patients with COVID-19 include the inhibition of pro-inflammatory cytokines by monocytes and macrophages, decreased production of neutrophil extracellular traps (NETs) by neutrophils, and inhibition of platelet aggregation; three pathways that are mediated through Fc receptors (FcR) recognition of antigen-antibody complexes or activation of c-type lectin receptors (CLEC).\n\nThis is a randomized, double-blind, placebo-controlled trial of fostamatinib for the treatment of hospitalized patients with COVID-19.\n\nWe will randomly assign fostamatinib or matched placebo (1:1) to 60 eligible COVID-19 patients who are a 5 to 7 on the 8-point scale (requiring supplemental oxygen via nasal canula or noninvasive ventilation, requiring mechanical ventilation or extracorporeal membrane oxygenation).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "* INCLUSION CRITERIA:\n\n 1. Patient must be hospitalized, or had their inpatient stay extended, for COVID-19.\n 2. Age \\>=18 years\n 3. Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.\n 4. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.\n 5. Females of childbearing potential must agree to be abstinent or use a medical acceptable form of contraception from the time of enrollment through 30 days after last day of study drug\n 6. Laboratory confirmed SARS-CoV-2 RT-PCR test within 7 days of enrollment\n 7. Illness of any duration with SpO2 of less than 94% on room air requiring supplemental oxygen via nasal canula or non-invasive mechanical ventilation, or mechanical ventilation or ECMO (5 to 7 on the 8-point scale)\n\nEXCLUSION CRITERIA:\n\n1. ALT or AST \\> 5 times the upper limit of normal (ULN) or ALT or AST \\>= 3 x ULN and total bilirubin \\> 2 x ULN.\n2. Estimated glomerular filtration rate (eGFR) \\<30ml/min\n3. Pregnancy or breast feeding\n4. Anticipated discharge in the next 72 hours\n5. Allergy to study medication\n6. Uncontrolled hypertension (systolic blood pressure \\>160mmHg or diastolic blood pressure \\>100mmHg)\n7. Shock or hypotension at the time of enrollment\n8. Neutrophil count \\<1000/microliter\n9. Concern for bacterial or fungal sepsis\n10. Received immunomodulatory treatment within 30 days prior to enrollment e.g., Bruton's tyrosine kinase/phosphoinositide 3 kinase/Janus kinase inhibitor or cytokine-targeting biologic therapy (anti-TNF, IL-6)\n11. Received a live vaccine the last 4 weeks\n12. Those who were cognitively impaired or mentally disabled prior to COVID diagnosis\n13. Participation in another clinical trial for the treatment of COVID-19."}, 'identificationModule': {'nctId': 'NCT04579393', 'briefTitle': 'Fostamatinib for Hospitalized Adults With COVID-19', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'A Phase II Study Evaluating Fostamatinib for Hospitalized Adults With COVID-19', 'orgStudyIdInfo': {'id': '10000110'}, 'secondaryIdInfos': [{'id': '000110-H'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'fostamatinib in combination with standard of care (SOC) for the treatment of COVID-19', 'interventionNames': ['Drug: fostamatinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Intervention - Placebo', 'description': 'Placebo in combination with standard of care (SOC) for the treatment of COVID-19', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets to match fostamatinib 100 mg and 150 mg will be provided.', 'armGroupLabels': ['Intervention - Placebo']}, {'name': 'fostamatinib', 'type': 'DRUG', 'description': 'The study intervention is fostamatinib, an inhibitor of spleen tyrosine kinase that will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses. Subjects will receive standard of care and be randomized to receive fostamatinib or matching placebo.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'INOVA Health Systems', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}], 'overallOfficials': [{'name': 'Jeffrey R Strich, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institutes of Health Clinical Center (CC)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}