Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:01 PM
Study NCT ID:
NCT04662060
Status:
COMPLETED
Last Update Posted:
2023-06-13
First Post:
2020-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Acebilustat Sub-Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-05-30', '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': 'C000625351', 'term': 'acebilustat'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'manisha.desai@stanford.edu', 'phone': '(650) 725-1946', 'title': 'Manesha Desai, PhD', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'up to 35 days', 'description': 'Safety Analysis Set: per protocol, the safety analysis was performed using the as-treated population and includes all patients who received study treatment. As pre-specified in the study protocol, any clinical events related to the progression of COVID-19 (except death) would not be considered adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants receive placebo for 28 days.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 3, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Acebilustat', 'description': 'Participants receive acebilustat 100 mg for 28 days.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 1, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'For Clinical Domain: Time-to-sustained-resolution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants receive placebo for 28 days.'}, {'id': 'OG001', 'title': 'Acebilustat', 'description': 'Participants receive acebilustat 100 mg for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'comment': 'Not calculable due to insufficient number of events', 'groupId': 'OG000', 'lowerLimit': '17.5', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not calculable due to insufficient number of events', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.34', 'ciUpperLimit': '1.04', 'pValueComment': 'A p-value of \\<0.05 would be considered statistically significant.', 'groupDescription': 'A two-sided log rank test at the 0.04999 level of significance for the final analysis required 78 events (i.e., sustained symptom resolution) to provide 80% power to detect a hazard ratio of 1.91. Based on previous outpatient COVID-19 trials at Stanford, assumed placebo and treatment arm median time to symptom resolution of 10 and 5 days, respectively, for a total sample size of 120 patients. Participants with missing data lasting through Day 28 were censored on Day 28.', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Two-sided Cox proportional hazards model adjusted for age, sex, and receipt of baseline receipt of monoclonal antibodies.'}], 'paramType': 'MEDIAN', 'timeFrame': '28 days', 'description': 'Time from randomization to sustained symptom resolution assessed over a 28-day period. Resolution is defined as the first day where no symptoms are self-reported on all succeeding days through and including day 28, not including sense of taste or smell, and defining recovery for fatigue and cough as mild or none.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analysis set'}, {'type': 'SECONDARY', 'title': 'For the Viral Domain: Change in Viral Shedding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants receive placebo for 28 days.'}, {'id': 'OG001', 'title': 'Acebilustat', 'description': 'Participants receive acebilustat 100 mg for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '1.7'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.7'}]}]}], 'analyses': [{'pValue': '0.20', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A p-value of \\<0.05 would be considered statistically significant.', 'groupDescription': 'A generalized linear mixed effects model with parameterization was utilized to capture the difference in change in viral shedding at day 10 between treatment arms. SARS-CoV2 viral RNA CT values were transformed using a standard Reference curve.', 'statisticalMethod': 'Linear mixed-effects regression model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 days', 'description': 'Change in shedding of SARS-CoV-2 virus through day 10 attained from self-collected nasal swab. Viral load (nucleic acid) was assessed by RT-PCR Ct over time, and is reported here as the average change in Ct values per day. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to \\~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2.', 'unitOfMeasure': 'cycles', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analysis set'}, {'type': 'SECONDARY', 'title': 'Time to Viral Cessation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants receive placebo for 28 days.'}, {'id': 'OG001', 'title': 'Acebilustat', 'description': 'Participants receive acebilustat 100 mg for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not calculable due to insufficient number of events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not calculable due to insufficient number of events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '28 days', 'description': 'Defined as the time in days from randomization to the first of two consecutive negative RT-PCR results of self-collected nasal swabs.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analysis set'}, {'type': 'SECONDARY', 'title': 'Time to First Resolution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants receive placebo for 28 days.'}, {'id': 'OG001', 'title': 'Acebilustat', 'description': 'Participants receive acebilustat 100 mg for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000', 'lowerLimit': '7.75', 'upperLimit': '18.25'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '18'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.38', 'ciUpperLimit': '1.01', 'statisticalMethod': 'Linear mixed-effects regression model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '28 days', 'description': 'Defined as the first study day where no symptoms are self-reported, not including sense of taste or smell, and defining recovery for fatigue and cough as mild or none.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analysis set'}, {'type': 'SECONDARY', 'title': 'Time to Full Resolution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants receive placebo for 28 days.'}, {'id': 'OG001', 'title': 'Acebilustat', 'description': 'Participants receive acebilustat 100 mg for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '8.75', 'upperLimit': '17.5'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '18'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '0.34', 'ciUpperLimit': '1.01', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '28 days', 'description': 'Defined as the study day where no symptoms are first self-reported.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analysis set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With SARS-CoV-2 Related Hospitalizations, Emergency Department (ED) Visits, or Death in Outpatients With COVID-19 Disease.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants receive placebo for 28 days.'}, {'id': 'OG001', 'title': 'Acebilustat', 'description': 'Participants receive acebilustat 100 mg for 28 days.'}], 'classes': [{'title': 'Hospitalization', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'ED visit', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A p-value of \\<0.05 would be considered statistically significant.', 'groupDescription': 'Difference in incidence of ED visits', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analysis set'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Developed Antibodies to SARS-CoV-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants receive placebo for 28 days.'}, {'id': 'OG001', 'title': 'Acebilustat', 'description': 'Participants receive acebilustat 100 mg for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available antibody data are included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants receive placebo for 28 days.'}, {'id': 'FG001', 'title': 'Acebilustat', 'description': 'Participants receive acebilustat 100 mg for 28 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'Received Allocated Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants receive placebo for 28 days.'}, {'id': 'BG001', 'title': 'Acebilustat', 'description': 'Participants receive acebilustat 100 mg for 28 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '41', 'spread': '14', 'groupId': 'BG000'}, {'value': '41', 'spread': '13', 'groupId': 'BG001'}, {'value': '41', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian/Alaska Native', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}, {'title': 'More than one race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fully Vaccinated', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26.9', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '26.8', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '26.8', 'spread': '6.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI 30+', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Received Monoclonal Antibody Therapy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Seropositivity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '≥10% neutralizing antibodies', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants with non-missing data'}, {'title': 'Days from Symptom Onset', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '5'}, {'value': '4', 'groupId': 'BG001', 'lowerLimit': '3', 'upperLimit': '5'}, {'value': '4', 'groupId': 'BG002', 'lowerLimit': '3', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Viral Shedding', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21.2', 'spread': '5.8', 'groupId': 'BG000'}, {'value': '20.5', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '20.8', 'spread': '6.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to \\~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2.', 'unitOfMeasure': 'cycles', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intent-to-treat population (all randomized participants)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-21', 'size': 1163532, 'label': 'Study Protocol and Statistical Analysis Plan: Master Protocol', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-02T12:25', 'hasProtocol': True}, {'date': '2021-09-21', 'size': 556724, 'label': 'Study Protocol and Statistical Analysis Plan: Acebilustat Sub-Protocol', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-02T12:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-09', 'studyFirstSubmitDate': '2020-12-08', 'resultsFirstSubmitDate': '2023-05-02', 'studyFirstSubmitQcDate': '2020-12-09', 'lastUpdatePostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-09', 'studyFirstPostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'For Clinical Domain: Time-to-sustained-resolution', 'timeFrame': '28 days', 'description': 'Time from randomization to sustained symptom resolution assessed over a 28-day period. Resolution is defined as the first day where no symptoms are self-reported on all succeeding days through and including day 28, not including sense of taste or smell, and defining recovery for fatigue and cough as mild or none.'}], 'secondaryOutcomes': [{'measure': 'For the Viral Domain: Change in Viral Shedding', 'timeFrame': '10 days', 'description': 'Change in shedding of SARS-CoV-2 virus through day 10 attained from self-collected nasal swab. Viral load (nucleic acid) was assessed by RT-PCR Ct over time, and is reported here as the average change in Ct values per day. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to \\~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2.'}, {'measure': 'Time to Viral Cessation', 'timeFrame': '28 days', 'description': 'Defined as the time in days from randomization to the first of two consecutive negative RT-PCR results of self-collected nasal swabs.'}, {'measure': 'Time to First Resolution', 'timeFrame': '28 days', 'description': 'Defined as the first study day where no symptoms are self-reported, not including sense of taste or smell, and defining recovery for fatigue and cough as mild or none.'}, {'measure': 'Time to Full Resolution', 'timeFrame': '28 days', 'description': 'Defined as the study day where no symptoms are first self-reported.'}, {'measure': 'Number of Participants With SARS-CoV-2 Related Hospitalizations, Emergency Department (ED) Visits, or Death in Outpatients With COVID-19 Disease.', 'timeFrame': '28 days'}, {'measure': 'Number of Participants That Developed Antibodies to SARS-CoV-2', 'timeFrame': '28 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Outpatient'], 'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '34274494', 'type': 'BACKGROUND', 'citation': "Bunning B, Hedlin H, Purington N, Sundaram V, Kapphahn K, Weng Y, Cunanan K, Maldonado Y, Singh U, Khosla C, O'Hara R, Nicolls M, Springman E, Parsonnet J, Rogers A, Levitt J, Desai M. The COVID-19 Outpatient Pragmatic Platform Study (COPPS): Study design of a multi-center pragmatic platform trial. Contemp Clin Trials. 2021 Sep;108:106509. doi: 10.1016/j.cct.2021.106509. Epub 2021 Jul 16."}, {'pmid': '36996150', 'type': 'RESULT', 'citation': 'Levitt JE, Hedlin H, Duong S, Lu D, Lee J, Bunning B, Elkarra N, Pinsky BA, Heffernan E, Springman E, Moss RB, Bonilla HF, Parsonnet J, Zamanian RT, Langguth JJ, Bollyky J, Khosla C, Nicolls MR, Desai M, Rogers AJ. Evaluation of Acebilustat, a Selective Inhibitor of Leukotriene B4 Biosynthesis, for Treatment of Outpatients With Mild-Moderate Coronavirus Disease 2019: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial. Clin Infect Dis. 2023 Jul 26;77(2):186-193. doi: 10.1093/cid/ciad187.'}]}, 'descriptionModule': {'briefSummary': 'The overall objective of this study is to efficiently evaluate the clinical efficacy and safety of different investigational therapeutics among adults who have COVID-19 but are not yet sick enough to require hospitalization. The overall hypothesis is that through an adaptive trial design, potential effective therapies (single and combination) may be identified for this group of patients.\n\nCOVID-19 Outpatient Pragmatic Platform Study (COPPS) is a pragmatic platform protocol designed to evaluate COVID-19 treatments by assessing their ability to reduce viral shedding (Viral Domain) or improve clinical outcomes (Clinical Domain). To be included into the platform, every investigational product will collect data for both Domain primary endpoints. Individual treatments to be evaluated in the platform will be described in separate sub-protocols.', 'detailedDescription': 'The platform study allows investigational products with objectives either: evaluating viral shedding (Virology Domain); and COVID-19 related Clinical Outcomes (Clinical Domain).\n\nThe primary objective for investigational products within the Viral Domain is:\n\nA. To evaluate the efficacy of each therapeutic intervention in addition to standard supportive care (SSC) compared with SSC in reducing viral shedding of SARS-CoV-2 virus in outpatients with COVID-19 disease.\n\nThe primary objective for investigational products within for the Clinical Domain is:\n\nB. To evaluate the efficacy of each therapeutic intervention in addition to SSC as compared to SSC in improving sustained clinical outcomes in outpatients with COVID-19 disease.\n\nSecondary objectives are:\n\n1. The objective of the non-assigned domain an investigational product is under.\n\n 1. If under Clinical Domain, reduction in viral shedding.\n 2. If under Viral Domain, time to resolution of symptoms.\n2. To evaluate the efficacy of each therapeutic intervention in reducing SARS-CoV-2 related hospitalizations, ED visits, or death in outpatients with COVID-19 disease.\n3. To assess the development of antibodies against SARS-CoV-2\n4. To evaluate the safety and tolerability of each therapeutic intervention compared with placebo (supportive care).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Outpatient setting\n2. Age ≥ 18 years and ≤ 80 years at the time of the assessment\n3. Able and willing to understand the study, adhere to all study procedures, and provide written informed consent\n4. Initial diagnosis of COVID-19 disease as defined by an FDA-cleared molecular diagnostic assay positive for SARS-CoV-2 with no more than 72 hours from the initial swab used in the diagnosis to the time of commencing informed consent.\n5. At baseline, at least two symptoms should have mild or higher severity score, where at least one of the mild symptoms is not cough, fatigue, or loss of smell/taste OR at least one symptom has a moderate or higher severity score on the COVID Outpatient Symptom Scale (COSS).\n6. Participant's COVID-19 related symptom onset occurred within 7 days prior to time of randomization.\n7. Other inclusion criteria specific to the investigational product that may, in the eyes of the investigator, be deemed necessary.\n\nExclusion Criteria:\n\n1. At screening, the participant needs to be admitted to the hospital or is being evaluated for potential admission.\n2. Previous use of experimental drugs that may be active against COVID-19 in the eyes of the investigators.\n3. Participant yields a positive urine pregnancy test at screening.\n4. Participant is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers).\n\n NOTE: Treatment of study participants following institutional COVID-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. This excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and NO, and co-enrollment into other clinical studies that evaluate investigational agents for COVID-19.\n5. Participant has a serious chronic disease (e.g., uncontrolled human immunodeficiency virus \\[HIV\\], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency).\n6. Has renal insufficiency including severe renal impairment and ESRD and/or requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD).\n7. Has liver impairment greater than Child Pugh A.\n8. Has a history of alcohol or drug abuse in the previous 6 months.\n9. Has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year.\n10. Has taken another investigational drug within the past 30 days.\n11. Is deemed by the Investigator to be ineligible for any reason.\n\nAdditional exclusion criteria for acebilustat protocol:\n\n1. Patient has abnormal liver enzyme tests at screening, including AST or ALT ≥3 × the upper limit of normal (ULN) or total bilirubin \\>1.25 × ULN at Screening (patients with known Gilbert's syndrome can be included with bilirubin \\>1.25 × ULN).\n2. Patient is pregnant or breastfeeding.\n3. Patients with baseline ALT \\>1.5 × ULN."}, 'identificationModule': {'nctId': 'NCT04662060', 'acronym': 'COPPS', 'briefTitle': 'COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Acebilustat Sub-Protocol', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'COVID-19 Outpatient Pragmatic Platform Study (COPPS): A Pragmatic Multi-arm, Adaptive, Phase 2, Blinded, Randomized Placebo-controlled Platform Trial to Assess the Efficacy of Different Investigational Therapeutics in Reducing Time to Disease Resolution or Viral Load Cessation, as Compared to Standard Supportive Care in Outpatients With COVID-19', 'orgStudyIdInfo': {'id': 'COPPS-Acebilustat'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acebilustat', 'description': 'Participants are randomized to receive acebilustat for 28 days.', 'interventionNames': ['Drug: Acebilustat']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matching Placebo', 'description': 'Participants are randomized to receive placebo to match acebilustat for 28 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Acebilustat', 'type': 'DRUG', 'description': '100 mg capsule administered orally once daily', 'armGroupLabels': ['Acebilustat']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to match acebilustat administered orally once daily', 'armGroupLabels': ['Matching Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Angela Rogers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Joseph Levitt, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}