Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-29 @ 11:15 AM
Study NCT ID:
NCT04870606
Status:
COMPLETED
Last Update Posted:
2024-01-02
First Post:
2021-04-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Proxalutamide (GT0918) Treatment for Outpatients With Mild or Moderate COVID-19 Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C000599887', 'term': 'proxalutamide'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'PR@kintor.com.cn', 'phone': '+86- 512 6263 9938', 'title': 'Millie Gu', 'organization': 'Suzhou Kintor Pharmaceuticals,Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to day 42; the investigator (and/or designee) documented all AEs reported by the subject from the time subjects given consent through completion of the EOS visit (day42) per protocol', 'description': 'If an event is not an AE per definition, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease).\n\nHospitalizations related to routine treatment or monitoring of the studied indication, not associated with any deterioration in condition should not be reported as SAEs.', 'eventGroups': [{'id': 'EG000', 'title': 'GT0918+ Standard of Care', 'description': 'Proxalutamide (GT0918): Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory', 'otherNumAtRisk': 365, 'deathsNumAtRisk': 365, 'otherNumAffected': 19, 'seriousNumAtRisk': 365, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo+ Standard of Care', 'description': 'Placebo: Placebo+Standard of care determined by PI and local regulatory', 'otherNumAtRisk': 365, 'deathsNumAtRisk': 365, 'otherNumAffected': 11, 'seriousNumAtRisk': 365, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Paraesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fibrin D dimer increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy in Terms of Clinical Status Following Treatment With Pruxelutamide (GT0918) Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GT0918+ Standard of Care', 'description': 'Proxalutamide (GT0918): Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory'}, {'id': 'OG001', 'title': 'Placebo+ Standard of Care', 'description': 'Placebo: Placebo+Standard of care determined by PI and local regulatory'}], 'classes': [{'categories': [{'measurements': [{'value': '361', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'In mITT (administrated at least one dose)，percentage of subjects who do not experience any of the following events due to all causes by Day 28:\n\n* Hospitalization for ≥ 24 hours, or\n* Supplemental oxygen for ≥24 hours in response to SpO2 ≤93%, or\n* Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'In mITT (administrated at least one dose)'}, {'type': 'PRIMARY', 'title': 'Sensitivity Analysis to Evaluate Efficacy in Terms of Clinical Status Following Treatment With Pruxelutamide (GT0918) Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GT0918+ Standard of Care', 'description': 'Proxalutamide (GT0918): Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory'}, {'id': 'OG001', 'title': 'Placebo+ Standard of Care', 'description': 'Placebo: Placebo+Standard of care determined by PI and local regulatory'}], 'classes': [{'categories': [{'measurements': [{'value': '348', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0181', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'paramValue': '0.025', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'In mITT (treatment period \\>7 days) , percentage of subjects who do not experience any of the following events due to all causes by Day 28:\n\n* Hospitalization for ≥ 24 hours, or\n* Supplemental oxygen for ≥24 hours in response to SpO2 ≤93%, or\n* Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT (treatment period \\>7 days) The mITT was defined as patients treated at least one dose. The primary outcome was analyzed based on mITT set.\n\nAt the same time, the sponsor did some sensitive analysis based on another mITT set, defined as patients treated longer than 7 days, to support the primary outcome analysis.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With Hospitalization by Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GT0918+ Standard of Care', 'description': 'Proxalutamide (GT0918): Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory'}, {'id': 'OG001', 'title': 'Placebo+ Standard of Care', 'description': 'Placebo: Placebo+Standard of care determined by PI and local regulatory'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1223', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'paramValue': '0.025', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Percentage of subjects who do experience any of the following events due to all causes by Day 28:\n\n* Hospitalization for ≥ 24 hours, or\n* Supplemental oxygen for ≥24 hours in response to SpO2 ≤93%, or\n* Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '272', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GT0918+ Standard of Care', 'description': 'Proxalutamide (GT0918): Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory'}, {'id': 'OG001', 'title': 'Placebo+ Standard of Care', 'description': 'Placebo: Placebo+Standard of care determined by PI and local regulatory'}], 'classes': [{'title': 'Days28', 'categories': [{'measurements': [{'value': '-5.4', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Days14', 'categories': [{'measurements': [{'value': '-4.8', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Days 7', 'categories': [{'measurements': [{'value': '-3.6', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Days 3', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'paramValue': '0.025', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at day 3,7,14,28', 'description': 'Changes from baseline in SARS-CoV-2 viral load at days 3, 7, 14, and 28.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The patient enrolled by local laboratory-confirmed SARS-CoV-2 infection; at the same time, Quantitative RT-qPCR done in the central laboratory was to determine the viral load change from different time points." Only the patients with positive dd-PCR test results, Limit of Detection with 59.9 copies/mL, were included in the viral load analysis, 277 patients in GT0918 group and 272 patients in placebo group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GT0918+ Standard of Care', 'description': 'Proxalutamide (GT0918): Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory'}, {'id': 'FG001', 'title': 'Placebo+ Standard of Care', 'description': 'Placebo: Placebo+Standard of care determined by PI and local regulatory'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '366'}, {'groupId': 'FG001', 'numSubjects': '367'}]}, {'type': 'Received at Least One Dose of Treatment After Randomised', 'achievements': [{'groupId': 'FG000', 'numSubjects': '365'}, {'groupId': 'FG001', 'numSubjects': '365'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '354'}, {'groupId': 'FG001', 'numSubjects': '359'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'A total of 865 subjects were screened, of whom 132 subjects failed at screening. A total of 733 subjects were randomized in this study', 'preAssignmentDetails': '733 subjects were randomized. 366 subjects were assigned to receive Pruxelutamide arm and 367 subjects were assigned to receive placebo arm. All randomized subjects were included in the ITT population.\n\n730 subjects, which included 365 subjects from each of the Pruxelutamide and placebo groups, were randomized and received at least one dose of treatment. These subjects were included in both the mITT and SS populations.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'BG000'}, {'value': '367', 'groupId': 'BG001'}, {'value': '733', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GT0918+ Standard of Care', 'description': 'Proxalutamide (GT0918): Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory'}, {'id': 'BG001', 'title': 'Placebo+ Standard of Care', 'description': 'Placebo: Placebo+Standard of care determined by PI and local regulatory'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41', 'spread': '13.82', 'groupId': 'BG000'}, {'value': '40.9', 'spread': '13.45', 'groupId': 'BG001'}, {'value': '41', 'spread': '13.63', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '368', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '365', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '322', 'groupId': 'BG000'}, {'value': '325', 'groupId': 'BG001'}, {'value': '647', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '86', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '323', 'groupId': 'BG000'}, {'value': '316', 'groupId': 'BG001'}, {'value': '639', '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': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '29.02', 'spread': '5.817', 'groupId': 'BG000'}, {'value': '29.03', 'spread': '6.625', 'groupId': 'BG001'}, {'value': '29.02', 'spread': '6.040', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Vaccination Status', 'classes': [{'categories': [{'title': 'Fully Vaccinated', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '292', 'groupId': 'BG002'}]}, {'title': 'Partially Vaccinated', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Non Vaccinated', 'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'COVID-19 Test Type', 'classes': [{'categories': [{'title': 'Molecular (RNA or PCR) Test', 'measurements': [{'value': '228', 'groupId': 'BG000'}, {'value': '236', 'groupId': 'BG001'}, {'value': '464', 'groupId': 'BG002'}]}, {'title': 'Antigen (Rapid) Test', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-08', 'size': 2049304, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-07T21:00', 'hasProtocol': True}, {'date': '2022-03-11', 'size': 795026, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-08-15T02:13', 'hasProtocol': False}, {'date': '2021-07-09', 'size': 432750, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-08-07T21:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 733}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-11', 'studyFirstSubmitDate': '2021-04-27', 'resultsFirstSubmitDate': '2023-08-14', 'studyFirstSubmitQcDate': '2021-04-29', 'lastUpdatePostDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-11', 'studyFirstPostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy in Terms of Clinical Status Following Treatment With Pruxelutamide (GT0918) Compared to Placebo', 'timeFrame': '28 days', 'description': 'In mITT (administrated at least one dose)，percentage of subjects who do not experience any of the following events due to all causes by Day 28:\n\n* Hospitalization for ≥ 24 hours, or\n* Supplemental oxygen for ≥24 hours in response to SpO2 ≤93%, or\n* Death'}, {'measure': 'Sensitivity Analysis to Evaluate Efficacy in Terms of Clinical Status Following Treatment With Pruxelutamide (GT0918) Compared to Placebo', 'timeFrame': '28 days', 'description': 'In mITT (treatment period \\>7 days) , percentage of subjects who do not experience any of the following events due to all causes by Day 28:\n\n* Hospitalization for ≥ 24 hours, or\n* Supplemental oxygen for ≥24 hours in response to SpO2 ≤93%, or\n* Death'}], 'secondaryOutcomes': [{'measure': 'Proportion of Subjects With Hospitalization by Day 28', 'timeFrame': '28 days', 'description': 'Percentage of subjects who do experience any of the following events due to all causes by Day 28:\n\n* Hospitalization for ≥ 24 hours, or\n* Supplemental oxygen for ≥24 hours in response to SpO2 ≤93%, or\n* Death'}, {'measure': 'Viral Load', 'timeFrame': 'at day 3,7,14,28', 'description': 'Changes from baseline in SARS-CoV-2 viral load at days 3, 7, 14, and 28.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Efficacy and Safety']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of Proxalutamide (GT0918) as a treatment for outpatients COVID-19 subjects.', 'detailedDescription': 'This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of Proxalutamide (GT0918) in adult outpatients diagnosed with mild to moderate COVID-19. The study will be 2-arm comparison against matched placebo. The study will be conducted in around 100 sites in the USA and other countries. This study utilizes an adaptive design that maximizes our efficiency in identifying a safe and efficacious therapeutic agent for COVID-19 during the current outbreak. There will be an interim analysis after 334 subjects complete Day 28 after the first dose to allow early stopping for futility, efficacy, or safety. The study population will be subjects with mild to moderate COVID-19 illness chosen to evaluate if early intervention with anti-androgen therapy prior to respiratory compromise can effectively prevent progression to the severe form of COVID-19 illness. Randomization is essential for establishing efficacy of these new therapeutic agents.\n\nThe blood samples for PK analysis need to be collected for at least 200 subjects, whom will also be randomized into the interventional treatment or placebo group with 1:1 ratio.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The subject or legally authorized representative give signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n2. Understand and agree to comply with planned study procedures.\n3. Male subjects with age ≥18 years of age at the time of randomization.\n4. Are currently not hospitalized.\n5. Have one or more mild or moderate symptom(s) COVID-19-related symptoms within 5 days of onset of symptoms onset\n6. Must have first positive SARS-CoV-2 viral infection determination (has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen) ≤3 days prior to start of the first dose.\n7. Regardless of their fertility status, male subjects must agree to either remain abstinent (if this is their preferred and usual lifestyle) or use condoms as well as one additional highly effective method of contraception (less than 1% failure rate) or effective method of contraception with nonpregnant women of childbearing potential partners for the duration of the study and until 90 days after the last dose.\n\n Use an acceptable method of contraception such as:\n * Highly effective methods of contraception (less than 1% failure rate) comprise, but are not limited to\n\n * combination oral contraceptives\n * implanted contraceptives, or\n * intrauterine devices.\n * Effective methods of contraception comprise but are not limited to\n\n * diaphragms with spermicide or cervical sponges.\n * men and their partners may choose to use a double-barrier method of contraception that must include use of a spermicide.\n8. Agree to the collection of nasopharyngeal swabs and venous blood.\n\nExclusion Criteria:\n\n1. Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 \\< 300, respiratory rate ≥30 per minute, heart rate ≥125 per minute\n2. Estimated glomerular filtration rate (eGFR) \\< 30 ml/min\n3. Serum total bilirubin \\> 1.5 x ULN (upper limit of normal) and AST and ALT \\>3x ULN\n4. Subjects with significant cardiovascular disease as following:\n\n i. heart failure NYHA class ≥3 ii. left ventricular ejection fraction \\<50% iii. those with a history of cardiac arrhythmias, including long QT syndrome.\n5. Has been admitted to a hospital prior to randomization, or is hospitalized (inpatient) at randomization, due to COVID-19 or requires treatment with supplemental oxygen.\n6. Have known allergies to any of the components used in the formulation of the interventions.\n7. Have hemodynamic instability requiring use of vasopressors within 24 hours of randomization.\n8. Suspected or proven serious, active bacterial, fungal, viral, or other infection (except COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention (i.e. known history of human immunodeficiency virus \\[HIV\\]).\n9. Have any co-morbidity requiring surgery within \\<7 days, or that is considered life-threatening within 30 days.\n10. Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.'}, 'identificationModule': {'nctId': 'NCT04870606', 'briefTitle': 'Proxalutamide (GT0918) Treatment for Outpatients With Mild or Moderate COVID-19 Illness', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Kintor Pharmaceutical Inc,'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Outpatients With Mild to Moderate COVID-19 Illness', 'orgStudyIdInfo': {'id': 'GT0918-US-3001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GT0918+ standard of care', 'description': 'Proxalutamide 200mg, oral, QD, for continuous 14 days, plus standard of care(n=334)', 'interventionNames': ['Drug: Proxalutamide (GT0918)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo+ standard of care', 'description': 'Placebo 200mg, oral, QD, for continuous 14 days, plus standard of care(n=334)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Proxalutamide (GT0918)', 'type': 'DRUG', 'otherNames': ['standard of care'], 'description': 'Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory', 'armGroupLabels': ['GT0918+ standard of care']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['standard of care'], 'description': 'Placebo+Standard of care determined by PI and local regulatory', 'armGroupLabels': ['placebo+ standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85051', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Absolute Clinical Research', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Long Beach Clinical Trials', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '29677', 'city': 'Sandy Springs', 'state': 'Georgia', 'country': 'United States', 'facility': 'WR-Mount Vernon Clinical Research, LLC', 'geoPoint': {'lat': 33.92427, 'lon': -84.37854}}, {'zip': '60618', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Olivo Medical and Wellness Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66218', 'city': 'Shawnee Mission', 'state': 'Kansas', 'country': 'United States', 'facility': 'Gtc Research', 'geoPoint': {'lat': 39.02, 'lon': -94.66583}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Platinum Research Network, LLC', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '29566', 'city': 'Little River', 'state': 'South Carolina', 'country': 'United States', 'facility': "Main Street Physician's Care", 'geoPoint': {'lat': 33.87323, 'lon': -78.61418}}, {'zip': '77024', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Lotus Clinical Research', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Wilson Lu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Suzhou Kintor Pharmaceuticals,Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Kintor Pharmaceutical Inc,', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}