Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-05 @ 10:29 PM
Study NCT ID:
NCT03403751
Status:
TERMINATED
Last Update Posted:
2021-10-12
First Post:
2018-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D010538', 'term': 'Peritonitis'}, {'id': 'D059413', 'term': 'Intraabdominal Infections'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000597133', 'term': 'AB103'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wayned@atoxbio.com', 'phone': '1-919-219-6377', 'title': 'Wayne M Dankner, MD, Chief Medical Officer', 'organization': 'Atox Bio, Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) reported here were collected from study drug administration through the Day 29 visit (28 days after study drug dosing).', 'description': 'Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments.', 'eventGroups': [{'id': 'EG000', 'title': 'Reltecimod 0.5 mg/kg', 'description': 'Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 7, 'seriousNumAtRisk': 28, 'deathsNumAffected': 5, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 8, 'seriousNumAtRisk': 30, 'deathsNumAffected': 6, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intra-abdominal fluid collection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal wall infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia escherichia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retroperitoneal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chemical peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal anastomotic complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal anastomotic leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urethral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Freedom From Durable Loss of Renal Function at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod 0.5 mg/kg', 'description': 'Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.649', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 Days', 'description': 'Freedom from durable loss of renal function at Day 28 required all of the following 3 components: alive at Day 28, free of dialysis at Day 28, and less than 37% loss of estimated glomerular filtration rate (eGFR) at Day 28 from patient reference eGFR (measured by Modification of Diet in Renal Disease \\[MDRD\\] formula).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population (modified intent-to-treat \\[mITT\\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed necrotizing soft tissue infection (NSTI) and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received.'}, {'type': 'PRIMARY', 'title': 'Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod 0.5 mg/kg', 'description': 'Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 Days', 'description': 'Number of patients experiencing at least one SAE', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population (As Treated/Safety Analysis Set) included all randomized patients who were exposed to study drug (reltecimod or placebo), with patients analyzed according to the treatment actually received.'}, {'type': 'PRIMARY', 'title': 'Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod 0.5 mg/kg', 'description': 'Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 Days', 'description': 'The number of patients experiencing at least one AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population (As Treated/Safety Analysis Set) included all randomized patients who were exposed to study drug (reltecimod or placebo), with patients analyzed according to the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Freedom From Durable Loss of Renal Function at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod 0.5 mg/kg', 'description': 'Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.871', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 Days', 'description': 'Freedom from durable loss of renal function at Day 14 required all of the following 3 components: alive at Day 14, free of dialysis at Day 14, and less than 37% loss of estimated glomerular filtration rate (eGFR) at Day 14 from patient reference eGFR (measured by Modification of Diet in Renal Disease \\[MDRD\\] formula).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population (modified intent-to-treat \\[mITT\\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Intensive Care Unit (ICU)-Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod 0.5 mg/kg', 'description': 'Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)'}], 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '28'}, {'value': '21.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '28'}]}]}], 'analyses': [{'pValue': '0.420', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '28 Days', 'description': 'ICU-free days refers to the number of days a patient did not spend time in the ICU through Day 28.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population (modified intent-to-treat \\[mITT\\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Ventilator-free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod 0.5 mg/kg', 'description': 'Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)'}], 'classes': [{'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '28'}, {'value': '26.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '28'}]}]}], 'analyses': [{'pValue': '0.448', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '28 Days', 'description': 'Ventilator-free days refers to the number of days a patient was not on a ventilator through Day 28.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population (modified intent-to-treat \\[mITT\\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Vasopressor-free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod 0.5 mg/kg', 'description': 'Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)'}], 'classes': [{'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '28'}, {'value': '26.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '28'}]}]}], 'analyses': [{'pValue': '0.579', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '28 Days', 'description': 'Vasopressor-free days refers to the number of days a patient did not receive a vasopressor through Day 28.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population (modified intent-to-treat \\[mITT\\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Hospital Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod 0.5 mg/kg', 'description': 'Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '61'}, {'value': '13.0', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '60'}]}]}], 'analyses': [{'pValue': '0.227', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '90 Days', 'description': 'Hospital days refers to the number of days a patient spent time in the hospital.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population (modified intent-to-treat \\[mITT\\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Cumulative Number of Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod 0.5 mg/kg', 'description': 'Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 Days', 'description': 'The number of deaths occurring through Day 90', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population (modified intent-to-treat \\[mITT\\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Secondary Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod 0.5 mg/kg', 'description': 'Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 Days', 'description': 'Number of patients experiencing at least one secondary infection', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population (As Treated/Safety Analysis Set) included all randomized patients who were exposed to study drug (reltecimod or placebo), with patients analyzed according to the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'ICU-free Days by Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 14 mSOFA <= 1', 'description': 'mSOFA total score on Day 14 of 0 or 1'}, {'id': 'OG001', 'title': 'Day 14 mSOFA >= 2', 'description': 'mSOFA total score on Day 14 of at least 2'}], 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '28'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '26'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '28 Days', 'description': 'The number of days a patient did not spend in the ICU through Day 28, by mSOFA category (mSOFA total score of 1 or less; mSOFA total score of 2 or more). Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population (modified intent-to-treat \\[mITT\\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients with available mSOFA data are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Ventilator-free Days by Day 14 mSOFA Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 14 mSOFA <= 1', 'description': 'mSOFA total score on Day 14 of 0 or 1'}, {'id': 'OG001', 'title': 'Day 14 mSOFA >= 2', 'description': 'mSOFA total score on Day 14 of at least 2'}], 'classes': [{'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '28'}, {'value': '17.0', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '28'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '28 Days', 'description': 'The number of days a patient was not on a ventilator through Day 28, by mSOFA category', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population (modified intent-to-treat \\[mITT\\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients with available mSOFA data are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Vasopressor-free Days by Day 14 mSOFA Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 14 mSOFA <= 1', 'description': 'mSOFA total score on Day 14 of 0 or 1'}, {'id': 'OG001', 'title': 'Day 14 mSOFA >= 2', 'description': 'mSOFA total score on Day 14 of at least 2'}], 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '28'}, {'value': '18.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '28'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '28 Days', 'description': 'The number of days a patient was not receiving a vasopressor through Day 28, by mSOFA category', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population (modified intent-to-treat \\[mITT\\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients with available mSOFA data are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Hospital Days by Day 14 mSOFA Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 14 mSOFA <= 1', 'description': 'mSOFA total score on Day 14 of 0 or 1'}, {'id': 'OG001', 'title': 'Day 14 mSOFA >= 2', 'description': 'mSOFA total score on Day 14 of at least 2'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '48'}, {'value': '23.5', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '61'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '90 Days', 'description': 'The number of days a patient was in the hospital.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population (modified intent-to-treat \\[mITT\\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients with available mSOFA data are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Hospital Discharge Location by Day 14 mSOFA Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 14 mSOFA <= 1', 'description': 'mSOFA total score on Day 14 of 0 or 1'}, {'id': 'OG001', 'title': 'Day 14 mSOFA >= 2', 'description': 'mSOFA total score on Day 14 of at least 2'}], 'classes': [{'title': 'More Favorable Discharge Location', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Less Favorable Discharge Location', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 Days', 'description': 'Number of patients with more favorable discharge location (home or rehabilitation facility) or less favorable discharge location (skilled nursing facility, another acute care facility, death, other) among patients alive at Day 14.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population (modified intent-to-treat \\[mITT\\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients alive at Day 14 with available data are included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cumulative Mortality by Day 14 mSOFA Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 14 mSOFA <= 1', 'description': 'mSOFA total score on Day 14 of 0 or 1'}, {'id': 'OG001', 'title': 'Day 14 mSOFA >= 2', 'description': 'mSOFA total score on Day 14 of at least 2'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '31.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 Days', 'description': 'Percentage of patients who died through Day 90 using life table analysis', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population (modified intent-to-treat \\[mITT\\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients with a screening mSOFA \\>= 3 are included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Reltecimod 0.5 mg/kg', 'description': 'Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Discontinuation (includes missing from Day 29)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Reltecimod 0.5 mg/kg', 'description': 'Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.7', 'spread': '14.6', 'groupId': 'BG000'}, {'value': '61.8', 'spread': '13.6', 'groupId': 'BG001'}, {'value': '61.7', 'spread': '14.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', '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': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '30.5', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '32.3', 'spread': '12.2', 'groupId': 'BG001'}, {'value': '31.4', 'spread': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Disease Category', 'classes': [{'categories': [{'title': 'Abdominal Infection', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Necrotizing Soft Tissue Infection (NSTI)', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Comorbidities', 'classes': [{'title': 'Diabetes', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Cardiovascular Disease', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Smoker', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Alcohol Abuse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Modified Sequential Organ Failure Assessment (mSOFA) Score', 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '5.4', 'spread': '3.1', 'groupId': 'BG001'}, {'value': '5.1', 'spread': '2.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Acute Physiology and Chronic Health Evaluation (APACHE) Score', 'classes': [{'categories': [{'measurements': [{'value': '17.1', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '16.4', 'spread': '7.9', 'groupId': 'BG001'}, {'value': '16.7', 'spread': '8.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Acute Physiology and Chronic Health Evaluation (APACHE) Score is a severity of illness classification system. It is determined within 24 hours of admission of a patient to an intensive care unit (ICU): an integer score from 0 to 71 is computed based on several measurements (physiologic variables, age, chronic health status).\n\nHigher scores correspond to more severe disease and a greater risk of death.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sepsis Presentation', 'classes': [{'title': 'Cardiovascular Organ Failure', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'Respiratory Organ Failure', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Acute Kidney Injury (AKI) Presentation', 'classes': [{'categories': [{'title': 'Stage 2 AKI', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Stage 3 AKI', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Acuity of AKI', 'classes': [{'categories': [{'title': 'AKI diagnosed at time of diagnosis of infection', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'AKI diagnosed during the 48h following diagnosis of infection', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This analysis population included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-31', 'size': 1651243, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-17T14:43', 'hasProtocol': True}, {'date': '2020-01-06', 'size': 1127595, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-17T14:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sponsor personnel and clinical research associates (CRAs) will also be blinded to study treatment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 randomization of study drug (Reltecimod) and placebo (normal saline)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'whyStopped': 'Very slow enrollment of target patient population', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'dispFirstSubmitDate': '2021-01-25', 'completionDateStruct': {'date': '2019-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-17', 'studyFirstSubmitDate': '2018-01-06', 'dispFirstSubmitQcDate': '2021-01-25', 'resultsFirstSubmitDate': '2021-08-18', 'studyFirstSubmitQcDate': '2018-01-11', 'dispFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-18', 'studyFirstPostDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cumulative Mortality by Day 14 mSOFA Category', 'timeFrame': '90 Days', 'description': 'Percentage of patients who died through Day 90 using life table analysis'}], 'primaryOutcomes': [{'measure': 'Freedom From Durable Loss of Renal Function at Day 28', 'timeFrame': '28 Days', 'description': 'Freedom from durable loss of renal function at Day 28 required all of the following 3 components: alive at Day 28, free of dialysis at Day 28, and less than 37% loss of estimated glomerular filtration rate (eGFR) at Day 28 from patient reference eGFR (measured by Modification of Diet in Renal Disease \\[MDRD\\] formula).'}, {'measure': 'Serious Adverse Events (SAEs)', 'timeFrame': '28 Days', 'description': 'Number of patients experiencing at least one SAE'}, {'measure': 'Adverse Events (AEs)', 'timeFrame': '28 Days', 'description': 'The number of patients experiencing at least one AE.'}], 'secondaryOutcomes': [{'measure': 'Freedom From Durable Loss of Renal Function at Day 14', 'timeFrame': '14 Days', 'description': 'Freedom from durable loss of renal function at Day 14 required all of the following 3 components: alive at Day 14, free of dialysis at Day 14, and less than 37% loss of estimated glomerular filtration rate (eGFR) at Day 14 from patient reference eGFR (measured by Modification of Diet in Renal Disease \\[MDRD\\] formula).'}, {'measure': 'Intensive Care Unit (ICU)-Free Days', 'timeFrame': '28 Days', 'description': 'ICU-free days refers to the number of days a patient did not spend time in the ICU through Day 28.'}, {'measure': 'Ventilator-free Days', 'timeFrame': '28 Days', 'description': 'Ventilator-free days refers to the number of days a patient was not on a ventilator through Day 28.'}, {'measure': 'Vasopressor-free Days', 'timeFrame': '28 Days', 'description': 'Vasopressor-free days refers to the number of days a patient did not receive a vasopressor through Day 28.'}, {'measure': 'Hospital Days', 'timeFrame': '90 Days', 'description': 'Hospital days refers to the number of days a patient spent time in the hospital.'}, {'measure': 'Cumulative Number of Deaths', 'timeFrame': '90 Days', 'description': 'The number of deaths occurring through Day 90'}, {'measure': 'Secondary Infections', 'timeFrame': '28 Days', 'description': 'Number of patients experiencing at least one secondary infection'}, {'measure': 'ICU-free Days by Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Category', 'timeFrame': '28 Days', 'description': 'The number of days a patient did not spend in the ICU through Day 28, by mSOFA category (mSOFA total score of 1 or less; mSOFA total score of 2 or more). Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.'}, {'measure': 'Ventilator-free Days by Day 14 mSOFA Category', 'timeFrame': '28 Days', 'description': 'The number of days a patient was not on a ventilator through Day 28, by mSOFA category'}, {'measure': 'Vasopressor-free Days by Day 14 mSOFA Category', 'timeFrame': '28 Days', 'description': 'The number of days a patient was not receiving a vasopressor through Day 28, by mSOFA category'}, {'measure': 'Hospital Days by Day 14 mSOFA Category', 'timeFrame': '90 Days', 'description': 'The number of days a patient was in the hospital.'}, {'measure': 'Hospital Discharge Location by Day 14 mSOFA Category', 'timeFrame': '90 Days', 'description': 'Number of patients with more favorable discharge location (home or rehabilitation facility) or less favorable discharge location (skilled nursing facility, another acute care facility, death, other) among patients alive at Day 14.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Abdominal sepsis', 'AKI', 'NSTI'], 'conditions': ['Acute Kidney Injury', 'Peritonitis', 'Necrotizing Soft Tissue Infection']}, 'descriptionModule': {'briefSummary': 'Phase 3 multicenter study to be conducted in up to 90 qualified participating sites globally to assess the efficacy and safety of Reltecimod vs placebo in patients with sepsis-associated Stage 2/3 AKI.', 'detailedDescription': 'Phase 3 randomized, placebo controlled study assessing the efficacy (complete recovery from AKI) and safety of Reltecimod in patients with suspected or confirmed abdominal sepsis (planned or completed surgical (laparotomy or laparoscopy) or interventional radiologic procedures for control of underlying abdominal infection within 24 hours of evaluation by medical personnel) or patients with surgically confirmed necrotizing soft tissue infection (NSTI), requiring intensive care unit (ICU) or step down unit admission and in whom the diagnosis of Stage 2/3 acute kidney injury (AKI; as defined by Kidney Disease Improving Global Outcomes (KDIGO) criteria) is established at initial presentation for medical evaluation or up to 48 hours from the suspected diagnosis of abdominal sepsis or from surgically confirmed diagnosis of NSTI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Has either suspected or documented diagnosis of abdominal sepsis requiring treatment with parenteral antibiotics and planned or completed surgical (laparotomy or laparoscopy) or interventional radiologic procedures within 24 hours of evaluation by medical personnel. Recommended surgical or interventional radiologic procedures be performed with 12 hours of evaluation by medical personnel.\n2. Initial diagnosis of AKI Stage 2 or 3 according to KDIGO AKI criteria established either upon presentation to medical care in those patients with suspected abdominal sepsis or in those patients in whom the initial diagnosis of AKI is established during the 48 hour period from the suspected diagnosis of abdominal sepsis.\n3. Study medication must be administered within 6 hours of confirmation of onset of Stage 2 or 3 AKI as established at the study site, under the following criteria:\n\n * After the decision is made by the attending surgeon at the study site for a surgical or interventional radiology procedure for the abdominal infection OR\n * After confirmed diagnosis of abdominal infection has been established by a surgical or interventional radiology procedure\n\nExclusion Criteria:\n\n1. Has known prior history of chronic kidney disease (CKD( with a documented estimated GFR (eGFR) \\< 30 mL/min\n\n • Exception: Patients with history of CKD but no available prior eGFR who have documented normal kidney size on ultrasound or computed tomography evaluation (performed within 90 days of screening) will be eligible\n2. Patients receiving renal replacment therapy (RRT) for CKD\n3. . Previously diagnosed with documented AKI in the last 30 days\n4. Documented primary glomerular disease or toxic tubulo-interstitial nephritis at the time of AKI diagnosis\n5. Patient is not expected to survive throughout 28 days of study due to significant underlying medical condition\n6. Any concurrent medical condition, which in the opinion of the Investigator, may compromise the safety of the patient or the objectives of the study or the patient will not benefit from treatment such as:\n\n * Congestive heart failure (CHF) {New York Heart Association (NYHA) class III-IV}\n * Severe chronic obstructive pulmonary disease (COPD) {GOLD - Global Initiative for Chronic Obstructive Lung Disease - stage IV. or chronic hypoxemia)\n * Liver dysfunction {Childs-Pugh class C}\n * Primary or acquired immunodeficiency or immunosuppression due to treatment with immunosuppressive medications\n * Known HIV infection with CD4 count \\< 200 cells/mm3 or \\< 14% of all lymphocytes\n * Neutropenia \\< 1,000 cells/mm3 not due to the underlying infection\n * Receiving or about to receive chemotherapy or biologic anti-cancer treatment,\n * Hematological and lymphatic malignancies in the last 5 years\n7. Patient has acute pancreatitis with no established source of infection, uncomplicated appendicitis, or cholangitis or cholecystitis without peritonitis;\n8. Pregnant or lactating women\n9. Concurrent or previous enrollment in a clinical trial involving investigational drug or a medical device'}, 'identificationModule': {'nctId': 'NCT03403751', 'briefTitle': 'Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury', 'organization': {'class': 'INDUSTRY', 'fullName': 'Atox Bio Ltd'}, 'officialTitle': 'Phase 3 Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Reltecimod as Compared to Placebo in Addition to Standard of Care in Patients With Sepsis-associated Acute Kidney Injury (SA-AKI)', 'orgStudyIdInfo': {'id': 'ATB-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reltecimod 0.5 mg/kg', 'description': 'Single IV infusion of Reltecimod 0.5 mg/kg', 'interventionNames': ['Drug: Reltecimod 0.5 mg/kg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Single IV infusion of 0.9% Sodium Chloride Injection (Normal Saline)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Reltecimod 0.5 mg/kg', 'type': 'DRUG', 'otherNames': ['AB103 0.5 mg/kg'], 'description': 'Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL) over approximately 10 minutes', 'armGroupLabels': ['Reltecimod 0.5 mg/kg']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['0.9% Sodium Chloride Injection (Normal saline)'], 'description': 'Single IV infusion of 0.5 mL/kg of 0.9% saline (volume equivalent to Reltecimod dosing schema) over approximately 10 minutes', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85008', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Maricopa Medical Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '24857', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Medical Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor-UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'UCH-Memorial Health System', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80045', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health Shands Hospital', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospital and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '70012', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'LSU Health Science Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland, Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'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': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Fairview Southdale Hospital', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hennepin County Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Medical Center-Fairview', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '65211', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '98638', 'city': 'Trenton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Capital Health System, Inc.', 'geoPoint': {'lat': 40.21705, 'lon': -74.74294}}, {'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Erie County Medical Center-Affliate of SUNYat Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '28208', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'East Carolina University', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Medical Center (UCMC)', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '18015', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "St. Luke's University Health Network", 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Pennsylvania State University and The Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Trauma Center at PENN', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'MUSC', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'John Peter Smith Health Network', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Argenteuil', 'country': 'France', 'facility': 'Hopital Victor Dupouy', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'city': 'Brest', 'country': 'France', 'facility': 'CHRU la Cavale Blanche', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'CHD Vendee', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'city': 'Le Mans', 'country': 'France', 'facility': 'CH Le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'city': 'Lille', 'country': 'France', 'facility': 'Robert Salengro Hopital-CHRU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Limoges', 'country': 'France', 'facility': 'CHU de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Lyon', 'country': 'France', 'facility': 'CHU Lyon Sud', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hopital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'Hopital Saint Eloi', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nante Hotel-Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hopital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rennes', 'country': 'France', 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'Nouvel Hopital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Azra Bihorac, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atox Bio Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}