Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT00457951
Status:
TERMINATED
Last Update Posted:
2021-12-02
First Post:
2007-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study Designed to Evaluate ODSH in Subjects With Exacerbations of COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zmasoud@chimerix.com', 'phone': '763-300-0559', 'title': 'Zahra Masoud', 'organization': 'Chimerix'}, 'certainAgreement': {'otherDetails': 'Confidentiality and Non-Disclosure Agreement', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'PGX-ODSH-2006, Ph II in patients with exacerbation of COPD. There were no safety issues. An interim analysis demonstrated lack of efficacy for the primary and secondary endpoints; therefore, Cantex terminated the study on August 11, 2009.'}}, 'adverseEventsModule': {'timeFrame': 'D1 to D90', 'description': 'Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Open Label', 'description': 'Initial six subjects treated with ODSH open-label to confirm safety in subjects with an acute exacerbation of COPD; six additional patients will be enrolled following safety review.\n\nOpen-Label: ODSH administered open-label', 'otherNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo Comparator: 0.9% Sodium Chloride', 'description': 'Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride Solution bolus; dose of 0.375mg/kg/hr over 96 hours.\n\nPlacebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride: Placebo-Control Arm: Bolus infusion followed by a 96 hour continuous infusion of 0.9%Sodium Chloride', 'otherNumAtRisk': 65, 'otherNumAffected': 13, 'seriousNumAtRisk': 65, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'ODSH Treatment Group', 'description': 'Subjects will receive standard of care treatment. ODSH is administered in bolus doses estimated to inhibit inflammatory mediators randomized 1:1 to ODSH 8mg/kg or placebo. The continuous infusion dose will be 0.375 mg/kg/hr over 96 hours.\n\nODSH: Randomized, Blinded, ODSH Arm', 'otherNumAtRisk': 69, 'otherNumAffected': 48, 'seriousNumAtRisk': 69, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'ALT Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 33, 'numAffected': 26}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'AST Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 29, 'numAffected': 22}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Retroperitoneal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Guillain-barre syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.9% Sodium Chloride', 'description': 'Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride Solution bolus; dose of 0.375mg/kg/hr over 96 hours.\n\nPlacebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride: Placebo-Control Arm: Bolus infusion followed by a 96 hour continuous infusion of 0.9%Sodium Chloride'}, {'id': 'OG001', 'title': 'Randomized, Blinded, ODSH Arm', 'description': 'Subjects will receive standard of care treatment. ODSH is administered in bolus doses estimated to inhibit inflammatory mediators randomized 1:1 to ODSH 8mg/kg or placebo. The continuous infusion dose will be 0.375 mg/kg/hr over 96 hours.\n\nODSH: Randomized, Blinded, ODSH Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '43'}, {'value': '32.4', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '42'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time to hospital discharge and 21 days post-treatment, up to 31 days', 'description': 'The primary outcome of the study is "Treatment Failure" as defined by Failure to discharge from hospital based on GOLD (Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease) criteria or relapse after DC from hospital.', 'unitOfMeasure': 'percentage of failures', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 138 subjects randomized, 132 were analyzed in the intent-to-treat population. Of the 6 excluded from the intent-to-treat population, 4 did not receive study drug and 2 lacked information for assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Open Label', 'description': 'Open Label\n\nThe original protocol called for 304 subjects with exacerbation of COPD to be enrolled into the study. Thirteen patients with exacerbation of COPD were enrolled in the initial open label portion of the study. Of these thirteen subjects, the initial seven subjects were treated with an IV bolus of ODSH at 8 mg/kg followed by a continuous infusion of ODSH at 0.5 mg/kg/hr for 72 hours.\n\nAfter an ad hoc safety committee assessed the safety of the data from the first seven subjects, six more subjects were treated concomitantly treated with ODSH and enoxaparin, a low molecular weight heparin commonly used for seriously ill hospitalized patients as DVT prophylaxis.'}, {'id': 'FG001', 'title': 'Placebo Comparator: 0.9% Sodium Chloride', 'description': 'Double-blind randomized phase: Normal Saline infusion: Bolus infusion followed by a 4 day continuous infusion of placebo.'}, {'id': 'FG002', 'title': 'ODSH Treatment Group', 'description': 'Double-blind randomized phase: The subjects receiving ODSH in the randomized portion of the study received 0.375 mg/kg/hr continuous IV infusion of ODSH for 96 hours.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'In the double-blind phase, 145 subjects consented and 138 met criteria and were randomized.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '72'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Open-Label', 'description': 'Open-Label ODSH'}, {'id': 'BG001', 'title': 'Placebo Comparator: Placebo-Control: 0.9% Sodium Chloride', 'description': 'Placebo Comparator: Placebo-Control: 0.9% Sodium Chloride Administered as bolus; then continuous administration over 96 hours in hospitalized subjects with exacerbations of COPD'}, {'id': 'BG002', 'title': 'ODSH Treatment Group', 'description': 'ODSH Treatment Group Administered as bolus; then continuous administration over 96 hours in hospitalized subjects with exacerbations of COPD'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '63.8', 'spread': '15', 'groupId': 'BG000'}, {'value': '68.5', 'spread': '10.24', 'groupId': 'BG001'}, {'value': '67.2', 'spread': '9.53', 'groupId': 'BG002'}, {'value': '66.5', 'spread': '10.43', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Open-Label followed by multi-center, randomized, double-blind, placebo-controlled trial in hospitalized subjects with exacerbations of COPD. In the double-blind phase, 145 subjects consented and 138 met criteria and were randomized.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'whyStopped': 'Interim analysis: safety without efficacy ODSH in patients with acute COPD.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-01', 'studyFirstSubmitDate': '2007-04-06', 'resultsFirstSubmitDate': '2016-01-26', 'studyFirstSubmitQcDate': '2007-04-06', 'lastUpdatePostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-25', 'studyFirstPostDateStruct': {'date': '2007-04-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment Failure', 'timeFrame': 'Time to hospital discharge and 21 days post-treatment, up to 31 days', 'description': 'The primary outcome of the study is "Treatment Failure" as defined by Failure to discharge from hospital based on GOLD (Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease) criteria or relapse after DC from hospital.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease', 'COPD', 'Heparin', 'ODSH', 'Exacerbations of COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether ODSH, when added to conventional treatment, is more effective in treating COPD exacerbations than conventional therapy alone.', 'detailedDescription': 'The management of acute exacerbations of COPD today is qualitatively the same as it was 40 years ago: bronchodilators, corticosteroids, and antibiotics. Because of the prominent pathophysiological role of neutrophils in exacerbations of COPD, neutrophils and their toxic oxidants and proteases represent therapeutic targets which are currently unchallenged in the treatment of this aspect of the disease. Ideally, to disrupt neutrophilic airway inflammation, one would both block neutrophilic influx from the vascular space into the airway, as well as neutralize or inactivate prominent neutrophilic toxins such as the proteases HLE and cathepsin G.\n\nHeparin is a sulfated mucopolysaccharide that slows blood clot formation by inhibiting the reactions that lead to formation of fibrin clots. Physicians use heparin to prevent blood clot formation during open-heart surgery, bypass surgery and dialysis. Heparin also prevents previously formed clots from becoming larger and causing more serious problems. Heparin has other biological properties, most notably anti-inflammatory activity. At doses required to be therapeutically beneficial as an anti-inflammatory, heparin can cause severe, potentially life-threatening hemorrhage. ParinGenix has chemically modified heparin to retain the anti-inflammatory activity while reducing anti-coagulant properties.\n\nHeparin has long been known to be a potent inhibitor, both in vitro and in vivo, of the cationic neutrophil proteases HLE and cathepsin G. However, heparin also has numerous other important anti-inflammatory effects. P-selectin is the primary endothelial attachment molecule mediating neutrophil rolling along the vessel wall. At concentrations close to those achieved in plasma near the high range of therapeutic anticoagulation, heparin inhibits P-selectin and P-selectin mediated interaction of leukocytes with endothelium. Heparin also blocks the leukocyte integrin Mac-1 (CD11b/CD18) and Mac-1-dependent leukocyte adherence to endothelial ICAM. These combined effects on rolling, integrin-dependent attachment and perhaps other aspects of cellular passage through the basement membrane prevent neutrophil accumulation in areas of inflammation. As an example, when given in much higher concentrations than those appropriate for therapeutic anticoagulation, heparin efficiently blocks neutrophilic influx into ischemic reperfused myocardium and brain reducing the size of both myocardial infarction and ischemic stroke. Thus, heparin and heparin analogues may have the potential to also reduce inflammatory influx of neutrophils into the airway during exacerbations of COPD.\n\nAll subjects will receive standard of care treatment, including corticosteroids, beta-2 agonists, and antibiotics as well as ODSH or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female patients (40 years of age or older) with an established diagnosis of COPD based upon medical history who are being admitted to the hospital to treat an exacerbation of COPD;\n2. Normal prothrombin time and activated partial thromboplastin time; Platelet count; hemoglobin and hematocrit\n\nExclusion Criteria:\n\n1. Certain diseases such as:\n\n * asthma;\n * left heart failure or pulmonary embolism;\n * lung cancer;\n * pneumonia\n * liver or kidney disease\n * blood clotting disorder\n * Positive HIV or hepatitis tests\n * GI bleeding, physical trauma with bleeding, any disease with bleeding within 60 days of study entry\n2. Certain medications such as:\n\n * Plavix®\n * Warfarin\n * Heparin therapy\n * Certain antibiotics\n3. Exacerbations that are too severe (requiring intubation and mechanical ventilation)\n4. Women of child-bearing potential, pregnancy or breast-feeding\n5. Unable or unwilling to provide informed consent and follow study procedures.'}, 'identificationModule': {'nctId': 'NCT00457951', 'acronym': 'COPD', 'briefTitle': 'A Study Designed to Evaluate ODSH in Subjects With Exacerbations of COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jazz Pharmaceuticals'}, 'officialTitle': 'An Open-Label Phase Followed by a Randomized, Double-Blind, Placebo-Controlled Phase in a Study Designed to Evaluate Intravenous 2-O, 3-O Desulfated Heparin (ODSH) in Subjects With Exacerbations of Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'PGX-ODSH-2006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open Label', 'description': 'Initial six subjects treated with ODSH open-label to confirm safety in subjects with an acute exacerbation of COPD; six additional patients will be enrolled following safety review.', 'interventionNames': ['Drug: Open-Label']}, {'type': 'PLACEBO_COMPARATOR', 'label': '0.9% Sodium Chloride', 'description': 'Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride Solution bolus; dose of 0.375mg/kg/hr over 96 hours.', 'interventionNames': ['Drug: Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Randomized, Blinded, ODSH Arm', 'description': 'Subjects will receive standard of care treatment. ODSH is administered in bolus doses estimated to inhibit inflammatory mediators randomized 1:1 to ODSH 8mg/kg or placebo. The continuous infusion dose will be 0.375 mg/kg/hr over 96 hours.', 'interventionNames': ['Drug: ODSH']}], 'interventions': [{'name': 'Open-Label', 'type': 'DRUG', 'otherNames': ['PGX-100'], 'description': 'ODSH administered open-label', 'armGroupLabels': ['Open Label']}, {'name': 'Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride', 'type': 'DRUG', 'otherNames': ['0.9% Sodium Chloride Solution Placebo-Control Arm'], 'description': 'Placebo-Control Arm: Bolus infusion followed by a 96 hour continuous infusion of 0.9%Sodium Chloride', 'armGroupLabels': ['0.9% Sodium Chloride']}, {'name': 'ODSH', 'type': 'DRUG', 'otherNames': ['PGX-100'], 'description': 'Randomized, Blinded, ODSH Arm', 'armGroupLabels': ['Randomized, Blinded, ODSH Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Pulmonary Consultants & Primary Care', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Wellstar Kennestone Hospital', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '71130', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University Health Sciences Center in Shreveport', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington Universtiy School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '97220', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'The Oregon Clinic', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University of the Commonwealth of Higher Education', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Michael E. 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