Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT04326920
Status:
COMPLETED
Last Update Posted:
2022-11-16
First Post:
2020-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Sargramostim in Patients With Acute Hypoxic Respiratory Failure Due to COVID-19 (SARPAC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D055371', 'term': 'Acute Lung Injury'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}], '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'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C081222', 'term': 'sargramostim'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cedric.bosteels@ugent.be', 'phone': '+3293325909', 'title': 'Cedric Bosteels', 'organization': 'UZ Gent'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Timeframe for reporting adverse events: through study completion, an average of 5 months', 'eventGroups': [{'id': 'EG000', 'title': 'Active Sargramostim Treatment Group', 'description': "Inhaled sargramostim 125mcg twice daily for 5 days on top of standard of care. Upon progression to ARDS and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration", 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 22, 'seriousNumAtRisk': 40, 'deathsNumAffected': 4, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Control Group', 'description': "standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, will have the option (clinician's decision) to initiate IV sargramostim 125mcg/m2 body surface area once daily for 5 days\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration\n\nControl: Standard of care", 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 20, 'seriousNumAtRisk': 41, 'deathsNumAffected': 8, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infectious disorder (not COVID-19)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Thormboembolic event', 'notes': 'pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventilator associated pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspergillus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory deterioration due to underlying MPO-ANCA vasculitis and aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'notes': 'Increasing hypoxemia due to COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Presyncope', 'notes': 'Progressive symptomatic orthostatism with presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Persistent catatonic state and neurological deficits', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Invasive aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Multi-bacterial bacteremia causing hemorrhagic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Improvement in Oxygenation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Sargramostim Treatment Group', 'description': "Inhaled sargramostim 125mcg twice daily for 5 days on top of standard of care. Upon progression to ARDS and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration"}, {'id': 'OG001', 'title': 'Control Group', 'description': "standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, will have the option (clinician's decision) to initiate IV sargramostim 125mcg/m2 body surface area once daily for 5 days\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration\n\nControl: Standard of care"}], 'classes': [{'categories': [{'measurements': [{'value': '25.7', 'spread': '85.3', 'groupId': 'OG000'}, {'value': '29.7', 'spread': '71.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'on Day 6 or hospital discharge, whichever came first', 'description': 'Mean Change from Baseline in PaO2/FiO2 on Day 6 or hospital discharge, whichever came first', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '73 of the 81 patients reached the evaluable primary endpoint. 2 patient discontinued prematurely, 3 patients refused arterial puncture at day 6, 3 patients were excluded because they had a negative P(A-a)O2 gradient at randomization or day 6, signifying an error in FiO2 recording.'}, {'type': 'SECONDARY', 'title': 'Mean Change in 6-point Ordinal Scale for Clinical Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Sargramostim Treatment Group', 'description': "Inhaled sargramostim 125mcg twice daily for 5 days on top of standard of care. Upon progression to ARDS and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration"}, {'id': 'OG001', 'title': 'Control Group', 'description': "standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, will have the option (clinician's decision) to initiate IV sargramostim 125mcg/m2 body surface area once daily for 5 days\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration\n\nControl: Standard of care"}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at Baseline, at Day 6', 'description': 'The 6-point ordinal scale for clinical improvement is defined as 1 = Death; 2 = Hospitalized, on invasive mechanical ventilation or ECMO (Extracorporeal Membrane Oxygenation) ; 3 = Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4 = Hospitalized, requiring supplemental oxygen; 5 = Hospitalized, not requiring supplemental oxygen; 6 = Not hospitalized. A higher score represent a better outcome', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Days in Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Sargramostim Treatment Group', 'description': "Inhaled sargramostim 125mcg twice daily for 5 days on top of standard of care. Upon progression to ARDS and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration"}, {'id': 'OG001', 'title': 'Control Group', 'description': "standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, will have the option (clinician's decision) to initiate IV sargramostim 125mcg/m2 body surface area once daily for 5 days\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration\n\nControl: Standard of care"}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '12'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '14'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'through study completion, an average of 5 months', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Nosocomial Infection no./Total no (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Sargramostim Treatment Group', 'description': "Inhaled sargramostim 125mcg twice daily for 5 days on top of standard of care. Upon progression to ARDS and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration"}, {'id': 'OG001', 'title': 'Control Group', 'description': "standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, will have the option (clinician's decision) to initiate IV sargramostim 125mcg/m2 body surface area once daily for 5 days\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration\n\nControl: Standard of care"}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during hospital admission (up to 28 days)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Sargramostim Treatment Group', 'description': "Inhaled sargramostim 125mcg twice daily for 5 days on top of standard of care. Upon progression to ARDS and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration"}, {'id': 'OG001', 'title': 'Control Group', 'description': "standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, will have the option (clinician's decision) to initiate IV sargramostim 125mcg/m2 body surface area once daily for 5 days\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration\n\nControl: Standard of care"}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 28 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Progressed to Mechanical Ventilation and/or ARDS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Sargramostim Treatment Group', 'description': "Inhaled sargramostim 125mcg twice daily for 5 days on top of standard of care. Upon progression to ARDS and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration"}, {'id': 'OG001', 'title': 'Control Group', 'description': "standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, will have the option (clinician's decision) to initiate IV sargramostim 125mcg/m2 body surface area once daily for 5 days\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration\n\nControl: Standard of care"}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during hospital admission (up to 28 days)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Clinical Sign Score < 6 for at Least 24h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Sargramostim Treatment Group', 'description': "Inhaled sargramostim 125mcg twice daily for 5 days on top of standard of care. Upon progression to ARDS and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration"}, {'id': 'OG001', 'title': 'Control Group', 'description': "standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, will have the option (clinician's decision) to initiate IV sargramostim 125mcg/m2 body surface area once daily for 5 days\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration\n\nControl: Standard of care"}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During hospital admission (up to 28 days)', 'description': 'Clinical Sign score (0-18) by scoring 6 clinical signs from 0 to 3 (0 = absent, 1 = mild, 2 = moderate and 3 = severe): Fever (0 = \\<37°C; 1 = 37.1-38°C; 2 = 38.1-39°C; 3 = \\>39°C) last 24h; Cough; Fatigue; Shortness of breath; Diarrhea; Body pain. Higher values represent a worse outcome', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Clinical Sign Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Sargramostim Treatment Group', 'description': "Inhaled sargramostim 125mcg twice daily for 5 days on top of standard of care. Upon progression to ARDS and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration"}, {'id': 'OG001', 'title': 'Control Group', 'description': "standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, will have the option (clinician's decision) to initiate IV sargramostim 125mcg/m2 body surface area once daily for 5 days\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration\n\nControl: Standard of care"}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at baseline, at day 6', 'description': 'Clinical Sign score (0-18) by scoring 6 clinical signs from 0 to 3 (0 = absent, 1 = mild, 2 = moderate and 3 = severe): Fever (0 = \\<37°C; 1 = 37.1-38°C; 2 = 38.1-39°C; 3 = \\>39°C) last 24h; Cough; Fatigue; Shortness of breath; Diarrhea; Body pain. Higher values represent a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in (National Early Warning Score2) NEWS2 Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Sargramostim Treatment Group', 'description': "Inhaled sargramostim 125mcg twice daily for 5 days on top of standard of care. Upon progression to ARDS and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration"}, {'id': 'OG001', 'title': 'Control Group', 'description': "standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, will have the option (clinician's decision) to initiate IV sargramostim 125mcg/m2 body surface area once daily for 5 days\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration\n\nControl: Standard of care"}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at baseline, at day 6', 'description': 'The NEWS2 score standardises the assessment and response to acute illness. Six physiological parameters form the basis of the scoring system:\n\nrespiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new confusion, temperature. The total possible score ranges from 0 to 20. The higher the score the greater the clinical risk', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Sequential Organ Failure Assessment (SOFA Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Sargramostim Treatment Group', 'description': "Inhaled sargramostim 125mcg twice daily for 5 days on top of standard of care. Upon progression to ARDS and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration"}, {'id': 'OG001', 'title': 'Control Group', 'description': "standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, will have the option (clinician's decision) to initiate IV sargramostim 125mcg/m2 body surface area once daily for 5 days\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration\n\nControl: Standard of care"}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at baseline, at day 6', 'description': 'The Sequential Organ Failure Assessment (SOFA) Score is a mortality prediction score that is based on the degree of dysfunction of six organ systems (respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems). Score ranges from 0 (best) to 24 (worst) points.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Ferritin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Sargramostim Treatment Group', 'description': "Inhaled sargramostim 125mcg twice daily for 5 days on top of standard of care. Upon progression to ARDS and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration"}, {'id': 'OG001', 'title': 'Control Group', 'description': "standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, will have the option (clinician's decision) to initiate IV sargramostim 125mcg/m2 body surface area once daily for 5 days\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration\n\nControl: Standard of care"}], 'classes': [{'categories': [{'measurements': [{'value': '-90', 'groupId': 'OG000', 'lowerLimit': '-150', 'upperLimit': '34'}, {'value': '-112', 'groupId': 'OG001', 'lowerLimit': '-259', 'upperLimit': '118'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'at baseline, at day 6', 'unitOfMeasure': 'mcg/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in D-dimer Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Sargramostim Treatment Group', 'description': "Inhaled sargramostim 125mcg twice daily for 5 days on top of standard of care. Upon progression to ARDS and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration"}, {'id': 'OG001', 'title': 'Control Group', 'description': "standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, will have the option (clinician's decision) to initiate IV sargramostim 125mcg/m2 body surface area once daily for 5 days\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration\n\nControl: Standard of care"}], 'classes': [{'categories': [{'measurements': [{'value': '-0.71', 'groupId': 'OG000', 'lowerLimit': '-1.79', 'upperLimit': '1.33'}, {'value': '-0.44', 'groupId': 'OG001', 'lowerLimit': '-2.90', 'upperLimit': '2.46'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'at baseline, at day 6', 'unitOfMeasure': 'nmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in CRP Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Sargramostim Treatment Group', 'description': "Inhaled sargramostim 125mcg twice daily for 5 days on top of standard of care. Upon progression to ARDS and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration"}, {'id': 'OG001', 'title': 'Control Group', 'description': "standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, will have the option (clinician's decision) to initiate IV sargramostim 125mcg/m2 body surface area once daily for 5 days\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration\n\nControl: Standard of care"}], 'classes': [{'categories': [{'measurements': [{'value': '-43.6', 'groupId': 'OG000', 'lowerLimit': '-69.8', 'upperLimit': '-21.7'}, {'value': '-43.1', 'groupId': 'OG001', 'lowerLimit': '-73.8', 'upperLimit': '-22.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'at baseline, at day 6', 'unitOfMeasure': 'mg/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Lymphocyte Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Sargramostim Treatment Group', 'description': "Inhaled sargramostim 125mcg twice daily for 5 days on top of standard of care. Upon progression to ARDS and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration"}, {'id': 'OG001', 'title': 'Control Group', 'description': "standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, will have the option (clinician's decision) to initiate IV sargramostim 125mcg/m2 body surface area once daily for 5 days\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration\n\nControl: Standard of care"}], 'classes': [{'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG000', 'lowerLimit': '0.18', 'upperLimit': '0.70'}, {'value': '0.20', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.56'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'at baseline, at day 6', 'unitOfMeasure': '*cells* x10^9/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Eosinophil Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Sargramostim Treatment Group', 'description': "Inhaled sargramostim 125mcg twice daily for 5 days on top of standard of care. Upon progression to ARDS and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration"}, {'id': 'OG001', 'title': 'Control Group', 'description': "standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, will have the option (clinician's decision) to initiate IV sargramostim 125mcg/m2 body surface area once daily for 5 days\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration\n\nControl: Standard of care"}], 'classes': [{'categories': [{'measurements': [{'value': '0.100', 'groupId': 'OG000', 'lowerLimit': '0.010', 'upperLimit': '0.160'}, {'value': '0.005', 'groupId': 'OG001', 'lowerLimit': '0.000', 'upperLimit': '0.073'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'at baseline, at day 6', 'unitOfMeasure': '*cells* x10^9/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'HRCT (High-Resolution Computed Tomography) Fibrosis Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Sargramostim Treatment Group', 'description': "Inhaled sargramostim 125mcg twice daily for 5 days on top of standard of care. Upon progression to ARDS and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration"}, {'id': 'OG001', 'title': 'Control Group', 'description': "standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, will have the option (clinician's decision) to initiate IV sargramostim 125mcg/m2 body surface area once daily for 5 days\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration\n\nControl: Standard of care"}], 'classes': [{'categories': [{'measurements': [{'value': '100.8', 'groupId': 'OG000', 'lowerLimit': '100.0', 'upperLimit': '102.5'}, {'value': '102.5', 'groupId': 'OG001', 'lowerLimit': '100.0', 'upperLimit': '105.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at follow-up, 10-20 weeks after day 10 or discharge, whichever comes first', 'description': 'The HRCT fibrosis score is a subjective assessment of the overall extent of normal attenuation, reticular abnormalities, honeycombing and traction bronchiectasis . The HRCT findings are graded on a scale of 1-4 based on the classification system: 1. normal attenuation; 2. reticular abnormality; 3. traction bronchiectasis; and 4. honeycombing. The presence of each of the above four HRCT findings is assessed independently in three (upper, middle and lower) zones of each lung. The extent of each HRCT finding was determined by visually estimating the percentage (to the nearest 5%) of parenchymal involvement in each zone. The score for each zone was calculated by multiplying the percentage of the area by the grading scale score (i.e. 1. normal attenuation; 2. reticular abnormality; 3. traction bronchiectasis; and 4. honeycombing). The six zone scores were averaged to determine the total score for each patient. The score ranges from 100 to 400, higher values represent more fibrosis.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Sargramostim Treatment Group', 'description': "Inhaled sargramostim 125mcg twice daily for 5 days on top of standard of care. Upon progression to ARDS and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration"}, {'id': 'FG001', 'title': 'Control Group', 'description': "standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, will have the option (clinician's decision) to initiate IV sargramostim 125mcg/m2 body surface area once daily for 5 days\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration\n\nControl: Standard of care"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '87 patients were screened in the period from 25-mar-2020 till 29-sep-2020. 87 patients were included, 81 patients were randomised, 79 patients completed the study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Sargramostim Treatment Group', 'description': "Inhaled sargramostim 125mcg twice daily for 5 days on top of standard of care. Upon progression to ARDS and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration"}, {'id': 'BG001', 'title': 'Control Group', 'description': "standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, will have the option (clinician's decision) to initiate IV sargramostim 125mcg/m2 body surface area once daily for 5 days\n\nSargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration\n\nControl: Standard of care"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '46', 'upperLimit': '68'}, {'value': '60', 'groupId': 'BG001', 'lowerLimit': '53', 'upperLimit': '69'}, {'value': '60', 'groupId': 'BG002', 'lowerLimit': '49', 'upperLimit': '69'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Arabian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Comorbidity at baseline', 'classes': [{'title': 'Arterial hypertension', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Diabetes mellitus', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Cardiovascular disease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Chronic kidney disease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Severe liver disease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Chronic lung disease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Cancer', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Patients without reported comorbidities', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking status at baseline', 'classes': [{'title': 'Current', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Former', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Never', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'smoking status at baseline', 'unitOfMeasure': 'Participants'}, {'title': 'Concomitant medication at randomization', 'classes': [{'title': 'Glucocorticoids', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Antiviral drugs (Remdesivir)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Hydroxychloroquine', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'Antibiotics', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Patients without reported concomitant medication', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': '6-category ordinal scale at baseline', 'classes': [{'title': '5 Hospitalized, no supplemental oxygen', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': '4 Hospitalized, supplemental oxygen', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}, {'title': '3 Hospitalized, Non Invasive Mechanical Ventilation (NIMV) or High Flow Oxygen Device (HFOD)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '6-category ordinal scale at baseline', 'unitOfMeasure': 'Participants'}, {'title': 'Lab values - C-reactive protein at baseline', 'classes': [{'categories': [{'measurements': [{'value': '73.2', 'groupId': 'BG000', 'lowerLimit': '39.1', 'upperLimit': '122.8'}, {'value': '83', 'groupId': 'BG001', 'lowerLimit': '38.4', 'upperLimit': '180'}, {'value': '74.5', 'groupId': 'BG002', 'lowerLimit': '38.75', 'upperLimit': '147.45'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Biomarkers in serum - IL1RA at baseline', 'classes': [{'categories': [{'measurements': [{'value': '839.3', 'groupId': 'BG000', 'lowerLimit': '595.8', 'upperLimit': '1494'}, {'value': '1288', 'groupId': 'BG001', 'lowerLimit': '905.1', 'upperLimit': '2350'}, {'value': '1162', 'groupId': 'BG002', 'lowerLimit': '678.40', 'upperLimit': '1806.00'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Oxygenation - PaO2/FiO2 ratio at baseline', 'classes': [{'categories': [{'measurements': [{'value': '291.5', 'groupId': 'BG000', 'lowerLimit': '251.5', 'upperLimit': '329'}, {'value': '297', 'groupId': 'BG001', 'lowerLimit': '242', 'upperLimit': '319.5'}, {'value': '295', 'groupId': 'BG002', 'lowerLimit': '248', 'upperLimit': '328'}]}]}], 'paramType': 'MEDIAN', 'description': 'PaO2/FiO2 ratio is the ratio of the partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2; PaO2/FiO2).', 'unitOfMeasure': 'ratio', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Oxygenation - P(A-a)O2 gradient at baseline', 'classes': [{'categories': [{'measurements': [{'value': '50.15', 'groupId': 'BG000', 'lowerLimit': '39.8', 'upperLimit': '63.75'}, {'value': '45.55', 'groupId': 'BG001', 'lowerLimit': '38.6', 'upperLimit': '61.75'}, {'value': '47.65', 'groupId': 'BG002', 'lowerLimit': '38.90', 'upperLimit': '61.75'}]}]}], 'paramType': 'MEDIAN', 'description': 'partial pressure of oxygen alveolar- arterial ( (P(A-a)O2 gradient)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Lab values - eosinophil count at baseline', 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0.1'}, {'value': '0.02', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0.09'}, {'value': '0.02', 'groupId': 'BG002', 'lowerLimit': '0.00', 'upperLimit': '0.10'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells x10^9/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Lab values - lymphocyte count at baseline', 'classes': [{'categories': [{'measurements': [{'value': '1.08', 'groupId': 'BG000', 'lowerLimit': '0.83', 'upperLimit': '1.4'}, {'value': '0.88', 'groupId': 'BG001', 'lowerLimit': '0.65', 'upperLimit': '1.22'}, {'value': '1.00', 'groupId': 'BG002', 'lowerLimit': '0.70', 'upperLimit': '1.30'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells x10^9/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Lab values - ferritin at baseline', 'classes': [{'categories': [{'measurements': [{'value': '736.5', 'groupId': 'BG000', 'lowerLimit': '446.5', 'upperLimit': '1063.5'}, {'value': '721', 'groupId': 'BG001', 'lowerLimit': '425', 'upperLimit': '1068'}, {'value': '721', 'groupId': 'BG002', 'lowerLimit': '425', 'upperLimit': '1068'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mcg/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Lab values - D-dimer at baseline', 'classes': [{'categories': [{'measurements': [{'value': '4.36', 'groupId': 'BG000', 'lowerLimit': '3.12', 'upperLimit': '5.8'}, {'value': '3.61', 'groupId': 'BG001', 'lowerLimit': '2.39', 'upperLimit': '5.04'}, {'value': '3.81', 'groupId': 'BG002', 'lowerLimit': '2.79', 'upperLimit': '5.31'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Lab values - lactate dehydrogenase at baseline', 'classes': [{'categories': [{'measurements': [{'value': '4.98', 'groupId': 'BG000', 'lowerLimit': '4.14', 'upperLimit': '6.4'}, {'value': '5.98', 'groupId': 'BG001', 'lowerLimit': '4.31', 'upperLimit': '6.86'}, {'value': '5.26', 'groupId': 'BG002', 'lowerLimit': '4.21', 'upperLimit': '6.68'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ukat/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Lab values - aspartate aminotransferase at baseline', 'classes': [{'categories': [{'measurements': [{'value': '0.62', 'groupId': 'BG000', 'lowerLimit': '0.44', 'upperLimit': '1.01'}, {'value': '0.65', 'groupId': 'BG001', 'lowerLimit': '0.57', 'upperLimit': '0.89'}, {'value': '0.65', 'groupId': 'BG002', 'lowerLimit': '0.48', 'upperLimit': '0.95'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ukat/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Lab values - alanine aminotransferase at baseline', 'classes': [{'categories': [{'measurements': [{'value': '0.59', 'groupId': 'BG000', 'lowerLimit': '0.38', 'upperLimit': '0.86'}, {'value': '0.57', 'groupId': 'BG001', 'lowerLimit': '0.4', 'upperLimit': '0.92'}, {'value': '0.58', 'groupId': 'BG002', 'lowerLimit': '0.40', 'upperLimit': '0.89'}]}]}], 'paramType': 'MEDIAN', 'description': 'alanine aminotransferase at baseline', 'unitOfMeasure': 'ukat/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Lab values - creatinine at baseline', 'classes': [{'categories': [{'measurements': [{'value': '75.14', 'groupId': 'BG000', 'lowerLimit': '68.07', 'upperLimit': '88.4'}, {'value': '78.68', 'groupId': 'BG001', 'lowerLimit': '68.07', 'upperLimit': '92.82'}, {'value': '77.35', 'groupId': 'BG002', 'lowerLimit': '68.07', 'upperLimit': '92.82'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'micromol/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Biomarkers in serum - IL-6 at baseline', 'classes': [{'categories': [{'measurements': [{'value': '11.47', 'groupId': 'BG000', 'lowerLimit': '4.50', 'upperLimit': '21.73'}, {'value': '11.54', 'groupId': 'BG001', 'lowerLimit': '4.85', 'upperLimit': '36.84'}, {'value': '11.54', 'groupId': 'BG002', 'lowerLimit': '4.85', 'upperLimit': '24.90'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Biomarkers in serum - IL-18 at baseline', 'classes': [{'categories': [{'measurements': [{'value': '101.3', 'groupId': 'BG000', 'lowerLimit': '73.8', 'upperLimit': '164.7'}, {'value': '150.7', 'groupId': 'BG001', 'lowerLimit': '87.13', 'upperLimit': '198.3'}, {'value': '131.00', 'groupId': 'BG002', 'lowerLimit': '80.32', 'upperLimit': '184.80'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Biomarkers in serum -C5a at baseline', 'classes': [{'categories': [{'measurements': [{'value': '11.18', 'groupId': 'BG000', 'lowerLimit': '3.91', 'upperLimit': '16.28'}, {'value': '8.83', 'groupId': 'BG001', 'lowerLimit': '4.52', 'upperLimit': '16.06'}, {'value': '9.94', 'groupId': 'BG002', 'lowerLimit': '4.37', 'upperLimit': '16.12'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Biomarkers in serum - GM-CSF at baseline', 'classes': [{'categories': [{'measurements': [{'value': '9.13', 'groupId': 'BG000', 'lowerLimit': '7.35', 'upperLimit': '12.42'}, {'value': '9.12', 'groupId': 'BG001', 'lowerLimit': '6.82', 'upperLimit': '13.39'}, {'value': '9.12', 'groupId': 'BG002', 'lowerLimit': '7.05', 'upperLimit': '12.71'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'fg/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Biomarkers in serum - TNF at baseline', 'classes': [{'categories': [{'measurements': [{'value': '16.32', 'groupId': 'BG000', 'lowerLimit': '12.17', 'upperLimit': '20.13'}, {'value': '14.77', 'groupId': 'BG001', 'lowerLimit': '8.53', 'upperLimit': '25.91'}, {'value': '14.99', 'groupId': 'BG002', 'lowerLimit': '10.66', 'upperLimit': '22.28'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Body Mass Index (BMI) at baseline', 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '33.8'}, {'value': '27.6', 'groupId': 'BG001', 'lowerLimit': '24.7', 'upperLimit': '33.1'}, {'value': '28.0', 'groupId': 'BG002', 'lowerLimit': '25.0', 'upperLimit': '33.4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Days since symptom onset at baseline', 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000', 'lowerLimit': '8.5', 'upperLimit': '14'}, {'value': '10', 'groupId': 'BG001', 'lowerLimit': '9', 'upperLimit': '13'}, {'value': '11.0', 'groupId': 'BG002', 'lowerLimit': '9.0', 'upperLimit': '13.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'day', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Days since hospitalization at baseline', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000', 'lowerLimit': '2.5', 'upperLimit': '4.5'}, {'value': '3', 'groupId': 'BG001', 'lowerLimit': '3', 'upperLimit': '5'}, {'value': '3.0', 'groupId': 'BG002', 'lowerLimit': '3.0', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Biomarkers in serum - IL-8 at baseline', 'classes': [{'categories': [{'measurements': [{'value': '22.51', 'groupId': 'BG000', 'lowerLimit': '14.14', 'upperLimit': '32.11'}, {'value': '27.44', 'groupId': 'BG001', 'lowerLimit': '15.91', 'upperLimit': '46.49'}, {'value': '23.99', 'groupId': 'BG002', 'lowerLimit': '15.91', 'upperLimit': '39.73'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-07', 'size': 2436492, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-03-03T07:07', 'hasProtocol': True}, {'date': '2021-03-05', 'size': 800095, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-20T05:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-15', 'studyFirstSubmitDate': '2020-03-24', 'resultsFirstSubmitDate': '2022-04-26', 'studyFirstSubmitQcDate': '2020-03-27', 'lastUpdatePostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-11', 'studyFirstPostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in Oxygenation', 'timeFrame': 'on Day 6 or hospital discharge, whichever came first', 'description': 'Mean Change from Baseline in PaO2/FiO2 on Day 6 or hospital discharge, whichever came first'}], 'secondaryOutcomes': [{'measure': 'Mean Change in 6-point Ordinal Scale for Clinical Improvement', 'timeFrame': 'at Baseline, at Day 6', 'description': 'The 6-point ordinal scale for clinical improvement is defined as 1 = Death; 2 = Hospitalized, on invasive mechanical ventilation or ECMO (Extracorporeal Membrane Oxygenation) ; 3 = Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4 = Hospitalized, requiring supplemental oxygen; 5 = Hospitalized, not requiring supplemental oxygen; 6 = Not hospitalized. A higher score represent a better outcome'}, {'measure': 'Number of Days in Hospital', 'timeFrame': 'through study completion, an average of 5 months'}, {'measure': 'Number of Participants With Nosocomial Infection no./Total no (%)', 'timeFrame': 'during hospital admission (up to 28 days)'}, {'measure': 'Death', 'timeFrame': 'at 28 days'}, {'measure': 'Number of Participants Progressed to Mechanical Ventilation and/or ARDS', 'timeFrame': 'during hospital admission (up to 28 days)'}, {'measure': 'Time to Clinical Sign Score < 6 for at Least 24h', 'timeFrame': 'During hospital admission (up to 28 days)', 'description': 'Clinical Sign score (0-18) by scoring 6 clinical signs from 0 to 3 (0 = absent, 1 = mild, 2 = moderate and 3 = severe): Fever (0 = \\<37°C; 1 = 37.1-38°C; 2 = 38.1-39°C; 3 = \\>39°C) last 24h; Cough; Fatigue; Shortness of breath; Diarrhea; Body pain. Higher values represent a worse outcome'}, {'measure': 'Change in Clinical Sign Score', 'timeFrame': 'at baseline, at day 6', 'description': 'Clinical Sign score (0-18) by scoring 6 clinical signs from 0 to 3 (0 = absent, 1 = mild, 2 = moderate and 3 = severe): Fever (0 = \\<37°C; 1 = 37.1-38°C; 2 = 38.1-39°C; 3 = \\>39°C) last 24h; Cough; Fatigue; Shortness of breath; Diarrhea; Body pain. Higher values represent a worse outcome.'}, {'measure': 'Change in (National Early Warning Score2) NEWS2 Score', 'timeFrame': 'at baseline, at day 6', 'description': 'The NEWS2 score standardises the assessment and response to acute illness. Six physiological parameters form the basis of the scoring system:\n\nrespiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new confusion, temperature. The total possible score ranges from 0 to 20. The higher the score the greater the clinical risk'}, {'measure': 'Change in Sequential Organ Failure Assessment (SOFA Score)', 'timeFrame': 'at baseline, at day 6', 'description': 'The Sequential Organ Failure Assessment (SOFA) Score is a mortality prediction score that is based on the degree of dysfunction of six organ systems (respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems). Score ranges from 0 (best) to 24 (worst) points.'}, {'measure': 'Change in Ferritin Level', 'timeFrame': 'at baseline, at day 6'}, {'measure': 'Change in D-dimer Level', 'timeFrame': 'at baseline, at day 6'}, {'measure': 'Change in CRP Level', 'timeFrame': 'at baseline, at day 6'}, {'measure': 'Change in Lymphocyte Count', 'timeFrame': 'at baseline, at day 6'}, {'measure': 'Change in Eosinophil Count', 'timeFrame': 'at baseline, at day 6'}, {'measure': 'HRCT (High-Resolution Computed Tomography) Fibrosis Score', 'timeFrame': 'at follow-up, 10-20 weeks after day 10 or discharge, whichever comes first', 'description': 'The HRCT fibrosis score is a subjective assessment of the overall extent of normal attenuation, reticular abnormalities, honeycombing and traction bronchiectasis . The HRCT findings are graded on a scale of 1-4 based on the classification system: 1. normal attenuation; 2. reticular abnormality; 3. traction bronchiectasis; and 4. honeycombing. The presence of each of the above four HRCT findings is assessed independently in three (upper, middle and lower) zones of each lung. The extent of each HRCT finding was determined by visually estimating the percentage (to the nearest 5%) of parenchymal involvement in each zone. The score for each zone was calculated by multiplying the percentage of the area by the grading scale score (i.e. 1. normal attenuation; 2. reticular abnormality; 3. traction bronchiectasis; and 4. honeycombing). The six zone scores were averaged to determine the total score for each patient. The score ranges from 100 to 400, higher values represent more fibrosis.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GM-CSF', 'Acute Lung Injury', 'Hypoxia', 'Acute Respiratory Distress Syndrome', 'Corona virus', 'COVID-19', 'SARS (Severe Acute Respiratory Syndrome)', 'Alveolar Macrophage', 'Acute Hypoxic respiratory failure'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '36459994', 'type': 'DERIVED', 'citation': 'Bosteels C, Van Damme KFA, De Leeuw E, Declercq J, Maes B, Bosteels V, Hoste L, Naesens L, Debeuf N, Deckers J, Cole B, Pardons M, Weiskopf D, Sette A, Weygaerde YV, Malfait T, Vandecasteele SJ, Demedts IK, Slabbynck H, Allard S, Depuydt P, Van Braeckel E, De Clercq J, Martens L, Dupont S, Seurinck R, Vandamme N, Haerynck F, Roychowdhury DF, Vandekerckhove L, Guilliams M, Tavernier SJ, Lambrecht BN. Loss of GM-CSF-dependent instruction of alveolar macrophages in COVID-19 provides a rationale for inhaled GM-CSF treatment. Cell Rep Med. 2022 Dec 20;3(12):100833. doi: 10.1016/j.xcrm.2022.100833. Epub 2022 Nov 15.'}, {'pmid': '32559419', 'type': 'DERIVED', 'citation': 'Mehta P, Porter JC, Manson JJ, Isaacs JD, Openshaw PJM, McInnes IB, Summers C, Chambers RC. Therapeutic blockade of granulocyte macrophage colony-stimulating factor in COVID-19-associated hyperinflammation: challenges and opportunities. Lancet Respir Med. 2020 Aug;8(8):822-830. doi: 10.1016/S2213-2600(20)30267-8. Epub 2020 Jun 16.'}, {'pmid': '32503663', 'type': 'DERIVED', 'citation': 'Bosteels C, Maes B, Van Damme K, De Leeuw E, Declercq J, Delporte A, Demeyere B, Vermeersch S, Vuylsteke M, Willaert J, Bolle L, Vanbiervliet Y, Decuypere J, Libeer F, Vandecasteele S, Peene I, Lambrecht B. Sargramostim to treat patients with acute hypoxic respiratory failure due to COVID-19 (SARPAC): A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun 5;21(1):491. doi: 10.1186/s13063-020-04451-7.'}]}, 'descriptionModule': {'briefSummary': 'Phase IV study to evaluate the effectiveness of additional inhaled sargramostim (GM-CSF) versus standard of care on blood oxygenation in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure.', 'detailedDescription': "Leukine® is a yeast-derived recombinant humanized granulocyte-macrophage colony stimulating factor (rhuGM-CSF, sargramostim) and the only FDA approved GM-CSF. GMCSF, a pleiotropic cytokine, is an important leukocyte growth factor known to play a key role in hematopoiesis, effecting the growth and maturation of multiple cell lineages as well as the functional activities of these cells in antigen presentation and cell mediated immunity.\n\nLeukine inhalation or intravenous administration, as an adjuvant therapy, may confer benefit to patients with ARDS (Acute Respiratory Distress Syndrome) due to COVID-19 exposure, who are at significant risk of mortality. While there is no active IND (Investigational New Drug) for Leukine in the proposed patient population, Leukine is being studied in Fase II as an adjuvant therapy in the management of life-threatening infections to boost the hosts innate immune response to fight infection, reduce the risk of secondary infection, and in varied conditions as prevention of infection during critical illness. Inhaled Leukine has also been successfully used as primary therapy to improve oxygenation in patients with disordered gas exchange in the lungs. We propose that based on preclinical and clinical data, Leukine inhalation, as an adjuvant therapy, has an acceptable benefit-risk for use in patients with hypoxic respiratory failure and ARDS due to COVID-19 exposure, who are at significant risk of mortality.\n\nConfirmed COVID19 patients with hypoxic respiratory failure (saturation below 93% on minimal 2 l/min O2) will be randomized to receive sargramostim 125mcg twice daily for 5 days as a nebulized inhalation on top of standard of care, or to receive standard of care treatment. Upon progression of disease requiring initiation of mechanical ventilatory support within the 5 day period, in patients in the active group, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment. In the control group progressive disease requiring mechanical ventilatory support, from day 6 onwards, the treating physician will have the option to initiate IV sargramostim 125mcg/m2 body surface area for 5 days. Safety data, including blood leukocyte counts, will be collected in all patients. Efficacy data will also be collected and will include arterial blood gases, oxygenation parameters, need for ventilation, lung compliance, organ function, radiographic changes, ferritin levels, etc. as well as occurrence of secondary bacterial infections."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recent (≤2weeks prior to Randomization) confident diagnosis of COVID-19 confirmed by antigen detection and/or PCR (Polymerase Chain Reaction), and/or seroconversion or any other emerging and validated diagnostic test\n* In some patients, it may be impossible to get a confident laboratory confirmation of COVID-19 diagnosis after 24h of hospital admission because viral load is low and/or problems with diagnostic sensitivity. In those cases, in absence of an alternative diagnosis, and with highly suspect bilateral ground glass opacities on recent (\\<24h) chest-CT scan (confirmed by a radiologist and pulmonary physician as probable COVID-19), a patient can be enrolled as probable COVID-19 infected. In all cases, this needs confirmation by later seroconversion.\n* Presence of acute hypoxic respiratory failure defined as (either or both)\n\n * saturation below 93% on minimal 2 l/min O2\n * PaO2/FiO2 below 300\n* Admitted to specialized COVID-19 ward\n* Age 18-80\n* Male or Female\n* Willing to provide informed consent\n\nExclusion Criteria:\n\n* Patients with known history of serious allergic reactions, including anaphylaxis, to human granulocyte-macrophage colony stimulating factor such as sargramostim, yeast-derived products, or any component of the product.\n* mechanical ventilation before start of study\n* patients with peripheral white blood cell count above 25.000 per microliter and/or active myeloid malignancy\n* patients on high dose systemic steroids (\\> 20 mg methylprednisolone or equivalent)\n* patients on lithium carbonate therapy\n* Patients enrolled in another investigational drug study\n* Pregnant or breastfeeding females (all female subjects regardless of childbearing potential status must have negative pregnancy test at screening)\n* Patients with serum ferritin \\>2000 mcg/ml (which will exclude ongoing HLH)'}, 'identificationModule': {'nctId': 'NCT04326920', 'acronym': 'SARPAC', 'briefTitle': 'Sargramostim in Patients With Acute Hypoxic Respiratory Failure Due to COVID-19 (SARPAC)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'A Prospective, Randomized, Open-label, Interventional Study to Investigate the Efficacy of Sargramostim (Leukine®) in Improving Oxygenation and Short- and Long-term Outcome of COVID-19 (Corona Virus Disease) Patients With Acute Hypoxic Respiratory Failure.', 'orgStudyIdInfo': {'id': 'SARPAC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active sargramostim treatment group', 'description': "Inhaled sargramostim 125mcg twice daily for 5 days on top of standard of care. Upon progression to ARDS and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment", 'interventionNames': ['Drug: Sargramostim']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': "standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, will have the option (clinician's decision) to initiate IV sargramostim 125mcg/m2 body surface area once daily for 5 days", 'interventionNames': ['Drug: Sargramostim', 'Other: Control']}], 'interventions': [{'name': 'Sargramostim', 'type': 'DRUG', 'otherNames': ['LEUKINE'], 'description': 'Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration', 'armGroupLabels': ['Active sargramostim treatment group', 'Control group']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Standard of care', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'AZ Sint Jan Brugge', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '1090', 'city': 'Jette', 'country': 'Belgium', 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}, {'zip': '8800', 'city': 'Roeselare', 'country': 'Belgium', 'facility': 'AZ Delta Roeselare', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}], 'overallOfficials': [{'name': 'Bart Lambrecht', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'Flemish institute of biotechnology (VIB)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, VIB-UGent Center for Inflammation Research', 'investigatorFullName': 'Bart N. Lambrecht', 'investigatorAffiliation': 'University Hospital, Ghent'}}}}