Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2026-03-08 @ 4:13 AM
Study NCT ID:
NCT04404361
Status:
TERMINATED
Last Update Posted:
2024-06-05
First Post:
2020-05-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-03-06', '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': 'C561234', 'term': '11-(2-pyrrolidin-1-ylethoxy)-14,19-dioxa-5,7,26-triazatetracyclo(19.3.1.1(2,6).1(8,12))heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene'}, {'id': 'D000075242', 'term': 'Janus Kinase Inhibitors'}], 'ancestors': [{'id': 'D047428', 'term': 'Protein Kinase Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jvolpone@ctibiopharma.com', 'phone': '206-351-7663', 'title': 'John Volpone', 'organization': 'CTI BioPharma Corp.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Daily (Days 2 through 28), End of Treatment (for inpatients only), Day of hospital discharge, Weekly outpatient assessment (to evaluate daily AEs), 30-day Post End of Treatment. AE data were collected from the time of randomization through 30 days following the last dose of pacritinib/placebo.', 'description': 'regular investigator assessment\n\n3 patients randomized to PAC but received the Placebo + SOC, the randomized treatment did not match with the actual treatment received. Because this is a safety summary the Safety population summarizes the information according to the actual treatment received and not the treatment that was assigned (randomized).', 'eventGroups': [{'id': 'EG000', 'title': 'Pacritinib and SOC', 'description': 'Pacritinib 400 mg once daily \\[QD\\] on Day 1, then 200 mg twice daily \\[BID\\] from Day 2 to Day 14) + SOC\n\nPacritinib: 100 mg capsules', 'otherNumAtRisk': 96, 'deathsNumAtRisk': 96, 'otherNumAffected': 74, 'seriousNumAtRisk': 96, 'deathsNumAffected': 12, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'Placebo and SOC', 'description': '4 capsules once daily \\[QD\\] on Day 1, then 2 capsules twice daily \\[BID\\] from Day 2 to Day 14) + SOC\n\nPlacebo: Placebo capsules matching pacritinib 100 mg capsules', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 79, 'seriousNumAtRisk': 101, 'deathsNumAffected': 12, 'seriousNumAffected': 33}], 'otherEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 17, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'seriousEvents': [{'term': 'respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Progression to IMV and/or ECMO or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pacritinib and SOC', 'description': 'Pacritinib 400 mg once daily \\[QD\\] on Day 1, then 200 mg twice daily \\[BID\\] from Day 2 to Day 14) + SOC\n\nPacritinib: 100 mg capsules'}, {'id': 'OG001', 'title': 'Placebo and SOC', 'description': '4 capsules once daily \\[QD\\] on Day 1, then 2 capsules twice daily \\[BID\\] from Day 2 to Day 14) + SOC\n\nPlacebo: Placebo capsules matching pacritinib 100 mg capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8516', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.51', 'ciLowerLimit': '-10.55', 'ciUpperLimit': '13.53', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test stratified by age (\\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5).'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Day 28', 'description': 'The percentage is calculated as the number of patients who progress to IMV/ECMO or death divided by the total number of patients in the ITT population (n/N \\* 100).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of Ventilator-Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pacritinib and SOC', 'description': 'Pacritinib 400 mg once daily \\[QD\\] on Day 1, then 200 mg twice daily \\[BID\\] from Day 2 to Day 14) + SOC\n\nPacritinib: 100 mg capsules'}, {'id': 'OG001', 'title': 'Placebo and SOC', 'description': '4 capsules once daily \\[QD\\] on Day 1, then 2 capsules twice daily \\[BID\\] from Day 2 to Day 14) + SOC\n\nPlacebo: Placebo capsules matching pacritinib 100 mg capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '22.1', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '22.6', 'spread': '9.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7494', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'description': 'the number of days that patients are alive and not intubated, from randomization to Day 28', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Mortality Rate at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pacritinib and SOC', 'description': 'Pacritinib 400 mg once daily \\[QD\\] on Day 1, then 200 mg twice daily \\[BID\\] from Day 2 to Day 14) + SOC\n\nPacritinib: 100 mg capsules'}, {'id': 'OG001', 'title': 'Placebo and SOC', 'description': '4 capsules once daily \\[QD\\] on Day 1, then 2 capsules twice daily \\[BID\\] from Day 2 to Day 14) + SOC\n\nPlacebo: Placebo capsules matching pacritinib 100 mg capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '17.8'}, {'value': '7.9', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '15.0'}]}]}], 'analyses': [{'pValue': '0.6323', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '0.46', 'ciUpperLimit': '3.58', 'estimateComment': 'OR from a CMH test stratified by randomization stratification factors age (\\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5) as entered in the IXRS', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Day 28', 'description': 'the number of patients with outcome of death during the 28 days following randomization', 'unitOfMeasure': '% of patients with outcome of death /D28', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Mortality Rate at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pacritinib and SOC', 'description': 'Pacritinib 400 mg once daily \\[QD\\] on Day 1, then 200 mg twice daily \\[BID\\] from Day 2 to Day 14) + SOC\n\nPacritinib: 100 mg capsules'}, {'id': 'OG001', 'title': 'Placebo and SOC', 'description': '4 capsules once daily \\[QD\\] on Day 1, then 2 capsules twice daily \\[BID\\] from Day 2 to Day 14) + SOC\n\nPlacebo: Placebo capsules matching pacritinib 100 mg capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '11.4'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '9.8'}]}]}], 'analyses': [{'pValue': '0.7541', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.25', 'ciLowerLimit': '0.31', 'ciUpperLimit': '4.96', 'estimateComment': 'OR from a CMH test Stratified by randomization stratification factors age (\\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5) as entered in the IXRS', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Day 15', 'description': 'the number of patients with outcome of death in the 15 days following randomization', 'unitOfMeasure': '% of patients with outcome of death /D15', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Time to Improvement by at Least 2 Points Relative to Baseline on the 7-point Ordinal Scale of Clinical Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pacritinib and SOC', 'description': 'Pacritinib 400 mg once daily \\[QD\\] on Day 1, then 200 mg twice daily \\[BID\\] from Day 2 to Day 14) + SOC\n\nPacritinib: 100 mg capsules'}, {'id': 'OG001', 'title': 'Placebo and SOC', 'description': '4 capsules once daily \\[QD\\] on Day 1, then 2 capsules twice daily \\[BID\\] from Day 2 to Day 14) + SOC\n\nPlacebo: Placebo capsules matching pacritinib 100 mg capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '10.0'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '11.0'}]}]}], 'analyses': [{'pValue': '0.5666', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.53', 'pValueComment': 'log-rank test stratified by randomization stratification factors age (\\<60 years versus\n\n≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5) as entered in the IXRS', 'estimateComment': 'estimated using a stratified Cox proportional hazards model stratified by randomization stratification factors age (\\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5)', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'stratified by randomization stratification factors age (\\<60 years versus\n\n≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5)'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Day 8, 15, 22, and 28.', 'description': 'Time to Improvement (days) = Date of improvement - Date of randomization + 1. Date of Improvement was defined as the time to first ordinal scale assessment 2 points or more lower than the baseline clinical status assessment.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pacritinib and SOC', 'description': 'Pacritinib 400 mg once daily \\[QD\\] on Day 1, then 200 mg twice daily \\[BID\\] from Day 2 to Day 14) + SOC\n\nPacritinib: 100 mg capsules'}, {'id': 'OG001', 'title': 'Placebo and SOC', 'description': '4 capsules once daily \\[QD\\] on Day 1, then 2 capsules twice daily \\[BID\\] from Day 2 to Day 14) + SOC\n\nPlacebo: Placebo capsules matching pacritinib 100 mg capsules'}], 'classes': [{'title': 'Day 8 : Clinical status 1', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Day 8 : Clinical status 2', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Day 8 : Clinical status 3', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Day 8 : Clinical status 4', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Day 8 : Clinical status 5', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Day 8 : Clinical status 6', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Day 8 : Clinical status 7', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 8 : Clinical status Missing', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: Clinical status 1', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: Clinical status 2', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: Clinical status 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: Clinical status 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: Clinical status 5', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: Clinical status 6', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: Clinical status 7', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: Clinical status Missing', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Day 22: Clinical status 1', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Day 22: Clinical status 2', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Day 22: Clinical status 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 22: Clinical status 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 22: Clinical status 5', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 22: Clinical status 6', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Day 22: Clinical status 7', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 22: Clinical status Missing', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Day 28: Clinical status 1', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Day 28: Clinical status 2', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Day 28: Clinical status 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 28: Clinical status 4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 28: Clinical status 5', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 28: Clinical status 6', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Day 28: Clinical status 7', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 28: Clinical status Missing', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 8, 15, 22, 28', 'description': 'Clinical status assessment based on the adapted scale from Cao et al. The patient CS is summarized by study visit.\n\nSTATUS:\n\n1. not hospitalized with resumption of normal activities;\n2. not hospitalized but unable to resume normal activities;\n3. hospitalization, not requiring supplemental oxygen;\n4. hospitalization, requiring supplemental oxygen not meeting the criteria for categories 5 or 6;\n5. hospitalization, on non-invasive positive pressure ventilation or high-flow nasal cannula;\n6. hospitalization, requiring IMV and/or ECMO;\n7. death.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Rate of Use of Immunomodulatory Agents as Treatment for COVID-19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pacritinib and SOC', 'description': 'Pacritinib 400 mg once daily \\[QD\\] on Day 1, then 200 mg twice daily \\[BID\\] from Day 2 to Day 14) + SOC\n\nPacritinib: 100 mg capsules'}, {'id': 'OG001', 'title': 'Placebo and SOC', 'description': '4 capsules once daily \\[QD\\] on Day 1, then 2 capsules twice daily \\[BID\\] from Day 2 to Day 14) + SOC\n\nPlacebo: Placebo capsules matching pacritinib 100 mg capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2722', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.46', 'ciLowerLimit': '0.47', 'ciUpperLimit': '12.93', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Day 28', 'description': 'the proportion of patients reporting use of medications such as corticosteroids, tocilizumab, anakinra, or eculizumab as treatment for COVID-19, during 28 days following randomization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pacritinib and SOC', 'description': 'Pacritinib 400 mg once daily \\[QD\\] on Day 1, then 200 mg twice daily \\[BID\\] from Day 2 to Day 14) + SOC\n\nPacritinib: 100 mg capsules'}, {'id': 'FG001', 'title': 'Placebo and SOC', 'description': '4 capsules once daily \\[QD\\] on Day 1, then 2 capsules twice daily \\[BID\\] from Day 2 to Day 14) + SOC\n\nPlacebo: Placebo capsules matching pacritinib 100 mg capsules'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Patients who completed the study through 30 days after last dose of study treatment', 'groupId': 'FG000', 'numSubjects': '68'}, {'comment': 'Patients who completed the study through 30 days after last dose of study treatment', 'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'patient hospitalized and was nonverbal at the end of the study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pacritinib and SOC', 'description': 'Pacritinib 400 mg once daily \\[QD\\] on Day 1, then 200 mg twice daily \\[BID\\] from Day 2 to Day 14) + SOC\n\nPacritinib: 100 mg capsules'}, {'id': 'BG001', 'title': 'Placebo and SOC', 'description': '4 capsules once daily \\[QD\\] on Day 1, then 2 capsules twice daily \\[BID\\] from Day 2 to Day 14) + SOC\n\nPlacebo: Placebo capsules matching pacritinib 100 mg capsules'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '87'}, {'value': '59.0', 'groupId': 'BG001', 'lowerLimit': '28', 'upperLimit': '94'}, {'value': '60.0', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '94'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age group', 'categories': [{'title': '<60 years', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}, {'title': '≥60 years', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Age groups \\<60 years and ≥60 years', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', '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': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-11', 'size': 829120, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-29T10:30', 'hasProtocol': True}, {'date': '2021-09-13', 'size': 1000863, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-08-16T09:09', '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': 200}}, 'statusModule': {'whyStopped': 'decision to close enrollment early', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2020-05-22', 'resultsFirstSubmitDate': '2024-02-09', 'studyFirstSubmitQcDate': '2020-05-22', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-07', 'studyFirstPostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Progression to IMV and/or ECMO or Death', 'timeFrame': 'Baseline to Day 28', 'description': 'The percentage is calculated as the number of patients who progress to IMV/ECMO or death divided by the total number of patients in the ITT population (n/N \\* 100).'}], 'secondaryOutcomes': [{'measure': 'The Number of Ventilator-Free Days', 'timeFrame': 'Baseline to Day 28', 'description': 'the number of days that patients are alive and not intubated, from randomization to Day 28'}, {'measure': 'The Mortality Rate at Day 28', 'timeFrame': 'Baseline to Day 28', 'description': 'the number of patients with outcome of death during the 28 days following randomization'}, {'measure': 'The Mortality Rate at Day 15', 'timeFrame': 'Baseline to Day 15', 'description': 'the number of patients with outcome of death in the 15 days following randomization'}, {'measure': 'The Time to Improvement by at Least 2 Points Relative to Baseline on the 7-point Ordinal Scale of Clinical Status', 'timeFrame': 'Baseline, Day 8, 15, 22, and 28.', 'description': 'Time to Improvement (days) = Date of improvement - Date of randomization + 1. Date of Improvement was defined as the time to first ordinal scale assessment 2 points or more lower than the baseline clinical status assessment.'}, {'measure': 'The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28', 'timeFrame': 'Baseline, Day 8, 15, 22, 28', 'description': 'Clinical status assessment based on the adapted scale from Cao et al. The patient CS is summarized by study visit.\n\nSTATUS:\n\n1. not hospitalized with resumption of normal activities;\n2. not hospitalized but unable to resume normal activities;\n3. hospitalization, not requiring supplemental oxygen;\n4. hospitalization, requiring supplemental oxygen not meeting the criteria for categories 5 or 6;\n5. hospitalization, on non-invasive positive pressure ventilation or high-flow nasal cannula;\n6. hospitalization, requiring IMV and/or ECMO;\n7. death.'}, {'measure': 'The Rate of Use of Immunomodulatory Agents as Treatment for COVID-19', 'timeFrame': 'Baseline to Day 28', 'description': 'the proportion of patients reporting use of medications such as corticosteroids, tocilizumab, anakinra, or eculizumab as treatment for COVID-19, during 28 days following randomization'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID19', 'COVID-19', 'COVID'], 'conditions': ['COVID19', 'COVID-19', 'COVID']}, 'referencesModule': {'references': [{'pmid': '36469321', 'type': 'DERIVED', 'citation': 'Cafardi J, Miller C, Terebelo H, Tewell C, Benzaquen S, Park D, Egan P, Lebovic D, Pettit K, Whitman E, Tremblay D, Feld J, Buckley S, Roman-Torres K, Smith J, Craig A, Mascarenhas J. Efficacy and Safety of Pacritinib vs Placebo for Patients With Severe COVID-19: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2242918. doi: 10.1001/jamanetworkopen.2022.42918.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pacritinib in hospitalized patients with severe COVID-19 with or without cancer.', 'detailedDescription': "This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pacritinib in hospitalized patients with severe COVID-19 with or without cancer. Severe COVID-19 is defined as confirmed disease in patients who are hospitalized with hypoxia (blood oxygen saturation \\[SpO2\\] ≤93% on room air at sea level), respiratory rate \\>30, arterial oxygen partial pressure \\[PaO2\\]/ fraction of inspired oxygen \\[FiO2\\] \\<300, or lung infiltrates \\>50% but do not require IMV.\n\nPatients will be randomized 1:1 to receive pacritinib (400 mg once daily \\[QD\\] on Day 1, then 200 mg twice daily \\[BID\\] from Day 2 to Day 14) + SOC or placebo + SOC.\n\nAssigned treatment will continue for up to Day 14 or until the patient experiences intolerable adverse events (AEs), withdraws consent, or initiates another investigational therapy or until the study is terminated. Assigned therapy may be given for an additional 7 days (for a total of 21 days) with the approval of the Medical Monitor if, in the opinion of the investigator, the patient's clinical signs and symptoms are improving and the potential benefit outweighs the potential risk.In the event of hospital discharge, patients will complete treatment with the assigned therapy as an outpatient."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Hospitalized or will be hospitalized prior to randomization for the treatment of severe COVID-19 with SARS-CoV-2 infection confirmed by either a) a positive reverse transcriptase polymerase chain reaction (RT PCR) or b) an antigen-based test from any respiratory, nasopharyngeal, saliva, blood, or stool specimen at Screening or documented within 1 week prior to the start of Screening (Severe COVID-19 is defined as confirmed disease in patients who are hospitalized with hypoxia \\[SpO2 ≤93% on room air\\], respiratory rate \\>30, PaO2/FiO2 \\<300, but do not require IMV).\n2. Age ≥ 18 years\n3. Platelet count ≥ 50,000/µL\n4. If fertile, willing to use effective birth control methods during the study\n5. Provision of informed consent within 96 hours after hospitalization\n\nExclusion Criteria:\n\n1. In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments\n2. Currently intubated or intubated between screening and randomization\n3. Suspected active uncontrolled bacterial, fungal, viral, or other infection (besides COVID 19)\n4. Prior allogenic hematopoietic stem cell transplantation\n5. Active lung cancer or history of lung cancer within the past 12 months\n6. Any active grade 2 or higher hemorrhage\n7. Any active gastrointestinal or metabolic condition that could interfere with absorption of oral medication\n8. Uncontrolled intercurrent illness that, in the judgment of the treating physician, would limit compliance with study requirements\n9. Known seropositivity for human immunodeficiency virus with cluster of differentiation 4 (CD4) count \\< 200/mm3 within 3 months prior to randomization\n10. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination\n11. Concurrent enrollment in another interventional trial (investigational COVID-19 antiviral studies are permitted)\n12. Serum creatinine \\> 2.5 mg/dL\n13. Total bilirubin \\> 4× the upper limit of normal\n14. QT corrected by the Fridericia method (QTcF) prolongation \\> 480 msec\n15. Known history of New York Heart Association Class II, III, or IV congestive heart failure prior to hospital admission\n16. Known allergic reaction to any Janus kinase 2 (JAK2) inhibitor\n17. Exposure to any JAK2 inhibitor within 28 days\n18. Currently receiving a strong CYP3A4 inhibitor or strong P450 inducer (Appendix 1 and Appendix 2, respectively) and unable to stop the medication prior to the first dose of study drug and throughout the duration of study drug administration\n19. Treatment with cytoreductive chemotherapy administered within 14 days prior to randomization\n20. Administration of an IL 1 or IL 6 blocking immunomodulatory agent (such as tocilizumab, canakinumab, sarilumab, anakinra) within 48 hours prior to randomization\n21. Currently receiving therapeutic anticoagulation or anti platelet medication and unable to stop the medication prior to randomization. Prophylactic anticoagulation therapy or aspirin (≤ 100mg) are permitted.\n22. Unable to ingest capsules or tablets at randomization'}, 'identificationModule': {'nctId': 'NCT04404361', 'briefTitle': 'PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'CTI BioPharma'}, 'officialTitle': 'A Phase 2 Randomized, Double-blind, Placebo-controlled, Multicenter Study of Pacritinib Plus Standard of Care Versus Placebo and Standard of Care in Hospitalized Patients With Severe COVID-19 With or Without Cancer', 'orgStudyIdInfo': {'id': 'PAC319'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pacritinib and SOC', 'description': 'Pacritinib 400 mg once daily \\[QD\\] on Day 1, then 200 mg twice daily \\[BID\\] from Day 2 to Day 14) + SOC', 'interventionNames': ['Drug: Pacritinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo and SOC', 'description': '4 capsules once daily \\[QD\\] on Day 1, then 2 capsules twice daily \\[BID\\] from Day 2 to Day 14) + SOC', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pacritinib', 'type': 'DRUG', 'otherNames': ['SB1518', 'Oral Jak Inhibitor', 'Oral Irak inhibitor', 'Oral Csf1 inhibitor'], 'description': '100 mg capsules', 'armGroupLabels': ['Pacritinib and SOC']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsules matching pacritinib 100 mg capsules', 'armGroupLabels': ['Placebo and SOC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Ascension St. Vincent's Riverside Hospital", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Memorial Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46220', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'St. Vincent Medical Group, Inc', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21229', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'St. Agnes Healthcare', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48236', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Ascension St. John Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48374', 'city': 'Novi', 'state': 'Michigan', 'country': 'United States', 'facility': 'Ascension Providence Hospital - 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