Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-26 @ 1:04 PM
Study NCT ID:
NCT04323592
Status:
COMPLETED
Last Update Posted:
2020-06-24
First Post:
2020-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mconfalonieri@units.it', 'phone': '+393356895168', 'title': 'Prof. Marco Confalonieri', 'phoneExt': '4667', 'organization': 'University of Trieste'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '28 days', 'eventGroups': [{'id': 'EG000', 'title': 'Exposed to Methylprednisolone', 'description': 'SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at prolonged dose.\n\nInclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering slowly until normal CRP values (+20%) are reached.\n\nMethylprednisolone: after initial 80mg iv bolus followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description\n\nstandard care: usual standard of care:\n\n* respiratory support\n* empiric antibiotic therapy\n* mechanical ventilation (invasive or noninvasive)\n* pronation when possible\n* other treatment which can be used are: antivirals, chloroquine, vitamins', 'otherNumAtRisk': 83, 'deathsNumAtRisk': 83, 'otherNumAffected': 23, 'seriousNumAtRisk': 83, 'deathsNumAffected': 9, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Non-exposed to Methylprednisolone', 'description': 'Concurrent patients with the same inclusion/section exclusion criteria never treated with steroids, strictly matched according to gender and age (+/-10 years) and other three parameters:\n\nCRP, SOFA score, PaO2:FiO2 -\\> each parameter must be \\<20% difference between case and control.\n\nstandard care: usual standard of care:\n\n* respiratory support\n* empiric antibiotic therapy\n* mechanical ventilation (invasive or noninvasive)pronation when possible\n* other treatment which can be used are: antivirals, chloroquine, vitamins', 'otherNumAtRisk': 90, 'deathsNumAtRisk': 90, 'otherNumAffected': 21, 'seriousNumAtRisk': 90, 'deathsNumAffected': 24, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Bacterial superinfection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transaminase elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'QT elongation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed to Methylprednisolone', 'description': 'SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at prolonged dose.\n\nInclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering slowly until normal CRP values (+20%) are reached.\n\nMethylprednisolone: after initial 80mg iv bolus followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description\n\nstandard care: usual standard of care:\n\n* respiratory support\n* empiric antibiotic therapy\n* mechanical ventilation (invasive or noninvasive)\n* pronation when possible\n* other treatment which can be used are: antivirals, chloroquine, vitamins'}, {'id': 'OG001', 'title': 'Non-exposed to Methylprednisolone', 'description': 'Concurrent patients with the same inclusion/section exclusion criteria never treated with steroids, strictly matched according to gender and age (+/-10 years) and other three parameters:\n\nCRP, SOFA score, PaO2:FiO2 -\\> each parameter must be \\<20% difference between case and control.\n\nstandard care: usual standard of care:\n\n* respiratory support\n* empiric antibiotic therapy\n* mechanical ventilation (invasive or noninvasive)pronation when possible\n* other treatment which can be used are: antivirals, chloroquine, vitamins'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'We reported below the number of participants meeting at least one of three among death or ICU admission or Invasive mechanical ventilation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'In-hospital Death Within 28 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed to Methylprednisolone', 'description': 'SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at prolonged dose.\n\nInclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering slowly until normal CRP values (+20%) are reached.\n\nMethylprednisolone: after initial 80mg iv bolus followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description\n\nstandard care: usual standard of care:\n\n* respiratory support\n* empiric antibiotic therapy\n* mechanical ventilation (invasive or noninvasive)\n* pronation when possible\n* other treatment which can be used are: antivirals, chloroquine, vitamins'}, {'id': 'OG001', 'title': 'Non-exposed to Methylprednisolone', 'description': 'Concurrent patients with the same inclusion/section exclusion criteria never treated with steroids, strictly matched according to gender and age (+/-10 years) and other three parameters:\n\nCRP, SOFA score, PaO2:FiO2 -\\> each parameter must be \\<20% difference between case and control.\n\nstandard care: usual standard of care:\n\n* respiratory support\n* empiric antibiotic therapy\n* mechanical ventilation (invasive or noninvasive)pronation when possible\n* other treatment which can be used are: antivirals, chloroquine, vitamins'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'We reported below the number of participants who died within 28 days, during the hospital stay.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Admission to Intensive Care Unit (ICU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed to Methylprednisolone', 'description': 'SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at prolonged dose.\n\nInclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering slowly until normal CRP values (+20%) are reached.\n\nMethylprednisolone: after initial 80mg iv bolus followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description\n\nstandard care: usual standard of care:\n\n* respiratory support\n* empiric antibiotic therapy\n* mechanical ventilation (invasive or noninvasive)\n* pronation when possible\n* other treatment which can be used are: antivirals, chloroquine, vitamins'}, {'id': 'OG001', 'title': 'Non-exposed to Methylprednisolone', 'description': 'Concurrent patients with the same inclusion/section exclusion criteria never treated with steroids, strictly matched according to gender and age (+/-10 years) and other three parameters:\n\nCRP, SOFA score, PaO2:FiO2 -\\> each parameter must be \\<20% difference between case and control.\n\nstandard care: usual standard of care:\n\n* respiratory support\n* empiric antibiotic therapy\n* mechanical ventilation (invasive or noninvasive)pronation when possible\n* other treatment which can be used are: antivirals, chloroquine, vitamins'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'We reported below the number of participants admitted to ICU within 28 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Endotracheal Intubation (Invasive Mechanical Ventilation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed to Methylprednisolone', 'description': 'SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at prolonged dose.\n\nInclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering slowly until normal CRP values (+20%) are reached.\n\nMethylprednisolone: after initial 80mg iv bolus followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description\n\nstandard care: usual standard of care:\n\n* respiratory support\n* empiric antibiotic therapy\n* mechanical ventilation (invasive or noninvasive)\n* pronation when possible\n* other treatment which can be used are: antivirals, chloroquine, vitamins'}, {'id': 'OG001', 'title': 'Non-exposed to Methylprednisolone', 'description': 'Concurrent patients with the same inclusion/section exclusion criteria never treated with steroids, strictly matched according to gender and age (+/-10 years) and other three parameters:\n\nCRP, SOFA score, PaO2:FiO2 -\\> each parameter must be \\<20% difference between case and control.\n\nstandard care: usual standard of care:\n\n* respiratory support\n* empiric antibiotic therapy\n* mechanical ventilation (invasive or noninvasive)pronation when possible\n* other treatment which can be used are: antivirals, chloroquine, vitamins'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'We reported below the number of participants who needed endotracheal intubation during ICU admission', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in C-reactive Protein (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed to Methylprednisolone', 'description': 'SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at prolonged dose.\n\nInclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering slowly until normal CRP values (+20%) are reached.\n\nMethylprednisolone: after initial 80mg iv bolus followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description\n\nstandard care: usual standard of care:\n\n* respiratory support\n* empiric antibiotic therapy\n* mechanical ventilation (invasive or noninvasive)\n* pronation when possible\n* other treatment which can be used are: antivirals, chloroquine, vitamins'}, {'id': 'OG001', 'title': 'Non-exposed to Methylprednisolone', 'description': 'Concurrent patients with the same inclusion/section exclusion criteria never treated with steroids, strictly matched according to gender and age (+/-10 years) and other three parameters:\n\nCRP, SOFA score, PaO2:FiO2 -\\> each parameter must be \\<20% difference between case and control.\n\nstandard care: usual standard of care:\n\n* respiratory support\n* empiric antibiotic therapy\n* mechanical ventilation (invasive or noninvasive)pronation when possible\n* other treatment which can be used are: antivirals, chloroquine, vitamins'}], 'classes': [{'categories': [{'measurements': [{'value': '-82.08', 'spread': '28.24', 'groupId': 'OG000'}, {'value': '-34.34', 'spread': '66.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days', 'description': 'Change in C-reactive protein after 7 days from baseline. A reduction of CRP reveals a laboratory improvement.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Days Free From Mechanical Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed to Methylprednisolone', 'description': 'SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at prolonged dose.\n\nInclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering slowly until normal CRP values (+20%) are reached.\n\nMethylprednisolone: after initial 80mg iv bolus followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description\n\nstandard care: usual standard of care:\n\n* respiratory support\n* empiric antibiotic therapy\n* mechanical ventilation (invasive or noninvasive)\n* pronation when possible\n* other treatment which can be used are: antivirals, chloroquine, vitamins'}, {'id': 'OG001', 'title': 'Non-exposed to Methylprednisolone', 'description': 'Concurrent patients with the same inclusion/section exclusion criteria never treated with steroids, strictly matched according to gender and age (+/-10 years) and other three parameters:\n\nCRP, SOFA score, PaO2:FiO2 -\\> each parameter must be \\<20% difference between case and control.\n\nstandard care: usual standard of care:\n\n* respiratory support\n* empiric antibiotic therapy\n* mechanical ventilation (invasive or noninvasive)pronation when possible\n* other treatment which can be used are: antivirals, chloroquine, vitamins'}], 'classes': [{'categories': [{'measurements': [{'value': '19.11', 'spread': '8.73', 'groupId': 'OG000'}, {'value': '14.34', 'spread': '11.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'number of days free from mechanical ventilation (both invasive and non-invasive) by day 28', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exposed to Methylprednisolone', 'description': 'SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at prolonged dose.\n\nInclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering slowly until normal CRP values (+20%) are reached.\n\nMethylprednisolone: after initial 80mg iv bolus followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description\n\nstandard care: usual standard of care:\n\n* respiratory support\n* empiric antibiotic therapy\n* mechanical ventilation (invasive or noninvasive)\n* pronation when possible\n* other treatment which can be used are: antivirals, chloroquine, vitamins'}, {'id': 'FG001', 'title': 'Non-exposed to Methylprednisolone', 'description': 'Concurrent patients with the same inclusion/section exclusion criteria never treated with steroids, strictly matched according to gender and age (+/-10 years) and other three parameters:\n\nCRP, SOFA score, PaO2:FiO2 -\\> each parameter must be \\<20% difference between case and control.\n\nstandard care: usual standard of care:\n\n* respiratory support\n* empiric antibiotic therapy\n* mechanical ventilation (invasive or noninvasive)pronation when possible\n* other treatment which can be used are: antivirals, chloroquine, vitamins'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exposed to Methylprednisolone', 'description': 'SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at low prolonged dose.\n\nAt admission, inclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering until normal CRP values (+20%) are reached.\n\nMethylprednisolone: Methylprednisolone given at low prolonged dose infusion after initial 80mg iv bolus at admission followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description\n\nstandard care: usual standard of care:\n\n* oxygen therapy (regular or high-flow) and monitoring\n* empiric antibiotic therapy\n* mechanical ventilation (invasive or noninvasive)\n* ECMO when needed and available\n* pronati'}, {'id': 'BG001', 'title': 'Non-exposed to Methylprednisolone', 'description': 'Concurrent patients with the same inclusion/section exclusion criteria never treated with steroids, strictly matched according to gender and age (+/-10 years) and other three parameters:\n\nCRP, SOFA score, PaO2:FiO2 -\\> each parameter must be \\<20% difference between case and control.\n\nstandard care: usual standard of care:\n\n* oxygen therapy (regular or high-flow) and monitoring\n* empiric antibiotic therapy\n* mechanical ventilation (invasive or noninvasive)\n* ECMO when needed and available\n* pronation when possible\n* other treatment which can be used are: antivirals, chloroquine, vitamins'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], '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': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64.39', 'spread': '10.73', 'groupId': 'BG000'}, {'value': '67.08', 'spread': '8.24', 'groupId': 'BG001'}, {'value': '65.79', 'spread': '9.58', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'C-reactive Protein', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '136.92', 'spread': '72.57', 'groupId': 'BG000'}, {'value': '148.64', 'spread': '75.59', 'groupId': 'BG001'}, {'value': '143.01', 'spread': '74.17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PaO2/FiO2', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '152.02', 'spread': '49.84', 'groupId': 'BG000'}, {'value': '151.01', 'spread': '60.26', 'groupId': 'BG001'}, {'value': '151.50', 'spread': '55.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sequential Organ Failure Assessment (SOFA) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '3', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '3', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'description': 'Sum of subscales scoring the function of: nervous system, kidneys, coagulation, respiratory system, cardiovascular system, liver.\n\nValues ranging 0-24; higher values represent worse outcome.', 'unitOfMeasure': 'score', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Lactates', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.76', 'spread': '1.97', 'groupId': 'BG000'}, {'value': '1.34', 'spread': '0.51', 'groupId': 'BG001'}, {'value': '1.52', 'spread': '1.32', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Lymphocytes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '622.28', 'spread': '650.62', 'groupId': 'BG000'}, {'value': '954.5', 'spread': '914.7', 'groupId': 'BG001'}, {'value': '938.94', 'spread': '797.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cells/uL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'D-dimer', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '780', 'groupId': 'BG000', 'lowerLimit': '530', 'upperLimit': '1207'}, {'value': '890', 'groupId': 'BG001', 'lowerLimit': '506.75', 'upperLimit': '1757'}, {'value': '813', 'groupId': 'BG002', 'lowerLimit': '518', 'upperLimit': '1560.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ug/L Fibrinogen Equivalent Units (FEU)', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'lactate dehydrogenase (LDH)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '380', 'spread': '132.93', 'groupId': 'BG000'}, {'value': '413.06', 'spread': '143.83', 'groupId': 'BG001'}, {'value': '396.41', 'spread': '138.96', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Respiratory rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '23.74', 'spread': '5.95', 'groupId': 'BG000'}, {'value': '25.27', 'spread': '6.76', 'groupId': 'BG001'}, {'value': '24.55', 'spread': '6.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Breaths per minute', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-23', 'size': 3127364, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-05-27T12:18', 'hasProtocol': False}, {'date': '2020-03-23', 'size': 37347, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_004.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-05-27T16:24', 'hasProtocol': False}, {'date': '2020-03-23', 'size': 377125, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_006.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-06-17T05:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Previous specific informed consent, blood samples of some patients treated with methylprednisolone were collected, in order to have the possibility to do'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}, 'targetDuration': '4 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-23', 'studyFirstSubmitDate': '2020-03-19', 'resultsFirstSubmitDate': '2020-05-21', 'studyFirstSubmitQcDate': '2020-03-24', 'lastUpdatePostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-28', 'studyFirstPostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28', 'timeFrame': '28 days', 'description': 'We reported below the number of participants meeting at least one of three among death or ICU admission or Invasive mechanical ventilation.'}, {'measure': 'In-hospital Death Within 28 Days', 'timeFrame': '28 days', 'description': 'We reported below the number of participants who died within 28 days, during the hospital stay.'}, {'measure': 'Admission to Intensive Care Unit (ICU)', 'timeFrame': '28 days', 'description': 'We reported below the number of participants admitted to ICU within 28 days.'}, {'measure': 'Endotracheal Intubation (Invasive Mechanical Ventilation)', 'timeFrame': '28 days', 'description': 'We reported below the number of participants who needed endotracheal intubation during ICU admission'}], 'secondaryOutcomes': [{'measure': 'Change in C-reactive Protein (CRP)', 'timeFrame': '7 days', 'description': 'Change in C-reactive protein after 7 days from baseline. A reduction of CRP reveals a laboratory improvement.'}, {'measure': 'Number of Days Free From Mechanical Ventilation', 'timeFrame': '28 days', 'description': 'number of days free from mechanical ventilation (both invasive and non-invasive) by day 28'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2,', 'SARS', 'ARDS', 'Methylprednisolone'], 'conditions': ['Severe Acute Respiratory Syndrome (SARS) Pneumonia', 'Coronavirus Infections', 'ARDS, Human']}, 'referencesModule': {'references': [{'pmid': '32218915', 'type': 'BACKGROUND', 'citation': 'Nicastri E, Petrosillo N, Ascoli Bartoli T, Lepore L, Mondi A, Palmieri F, D\'Offizi G, Marchioni L, Murachelli S, Ippolito G, Antinori A. National Institute for the Infectious Diseases "L. Spallanzani", IRCCS. Recommendations for COVID-19 clinical management. Infect Dis Rep. 2020 Mar 16;12(1):8543. doi: 10.4081/idr.2020.8543. eCollection 2020 Feb 25.'}, {'pmid': '33072814', 'type': 'DERIVED', 'citation': "Salton F, Confalonieri P, Meduri GU, Santus P, Harari S, Scala R, Lanini S, Vertui V, Oggionni T, Caminati A, Patruno V, Tamburrini M, Scartabellati A, Parati M, Villani M, Radovanovic D, Tomassetti S, Ravaglia C, Poletti V, Vianello A, Gaccione AT, Guidelli L, Raccanelli R, Lucernoni P, Lacedonia D, Foschino Barbaro MP, Centanni S, Mondoni M, Davi M, Fantin A, Cao X, Torelli L, Zucchetto A, Montico M, Casarin A, Romagnoli M, Gasparini S, Bonifazi M, D'Agaro P, Marcello A, Licastro D, Ruaro B, Volpe MC, Umberger R, Confalonieri M. Prolonged Low-Dose Methylprednisolone in Patients With Severe COVID-19 Pneumonia. Open Forum Infect Dis. 2020 Sep 12;7(10):ofaa421. doi: 10.1093/ofid/ofaa421. eCollection 2020 Oct."}]}, 'descriptionModule': {'briefSummary': 'COVID-19 infection is overwhelming Italian healthcare. There is an urgent need for a solution to the lack of ICU beds and increasing deaths day after day.\n\nA recent retrospective Chinese paper (JAMA Intern Med, online March 13, 2020) showed impressive positive effect of methylprednisolone (MP) on survival of SARS-CoV-2 critically ill patients. Moreover, the Italian Infectious Disease leading institution guidelines for COVID-19 clinical management included as an option for patients with "incipient worsening of respiratory functions" methylprednisolone treatment at an approximate dose of 80mg.\n\nThe main objective of this multi-centre observational trial is to analyse the association of low dose prolonged infusion of methylprednisolone (MP) for patients with severe acute respiratory syndrome with composite primary end-point (ICU referral, need for intubation, in-hospital death at day 28).', 'detailedDescription': 'Comparison of two groups of patients SARS-CoV-2 positive with severe acute respiratory syndrome:\n\n1. Exposed to low prolonged doses of Methylprednisolone\n2. Not exposed to corticosteroids (standard of care alone)\n\nThe two group will be weighted by means of a propensity score according to:\n\n1. Sex\n2. Age\n3. C-reactive protein (CRP) at baseline\n4. Sequential Organ Failure Assessment (SOFA) score at baseline\n5. PaO2/FiO2 ratio at baseline (ratio of arterial oxygen partial pressure to fractional inspired oxygen)\n\nAnti-viral agents, chloroquine, respiratory support (any), and antibiotics (any) are allowed in each study group. Corticosteroids use, other than per-protocol Methylprednisolone in the exposed group is a reason for dropout.\n\n1. The exposed group is treated with Methylprednisolone at study entry (baseline) according to a protocol based on the Italian national recommendations for COVID-19 management: a loading dose of 80 mg IV, followed by an infusion of 80 mg/day in 240 mL normal saline at 10 mL/h. The infusion is continued for at least eight days and until achieving either a PaO2:FiO2 \\> 350 mmHg or a CRP \\< 20 mg/L. Treatment is then switched to oral administration of Methylprednisolone 16 mg or 20 mg IV twice daily until CRP returns to \\< 20% of normal range and/or PaO2:FiO2 \\> 400 or SatHbO2 ≥ 95%. The decision to apply the protocol to Covid-19 is left to the discretion of the treating team for each individual patient.\n2. Unexposed patients will be selected from concurrent consecutive COVID-19 patients with the same inclusion and exclusion criteria and blinded to outcome data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients admitted to Respiratory High dependency units for severe acute respiratory syndrome associated to COVID-19', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. SARS-CoV-2 positive\n2. Age \\>17 years and \\< 80 years\n3. P/F \\< 250 mmHg\n4. Bilateral pneumonia (infiltrates/interstitial)\n5. CRP \\>10mg/dL (or \\>100mg/L)\n6. Alternatively to 4-5-6 criteria a diagnosis of ARDS according to the Berlin definition (Ranieri M, et al. JAMA 2012)\n\nExclusion Criteria:\n\n* Heart failure as predominant cause of acute respiratory failure\n* Decompensated liver cirrhosis\n* Cancer\n* Organ transplantation\n* HIV+\n* dialysis\n* long-term oxygen therapy, home mechanical ventilation\n* Idiopathic pulmonary fibrosis\n* Progressive neuromuscular disorders (e.g. Duchenne, Pompe, ALS)\n* Dementia or decompensated psychiatric diseases\n* immunosuppressive treatments\n* Chronic use of corticosteroids\n* Use of Tocilizumab\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT04323592', 'acronym': 'MP-C19', 'briefTitle': 'Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Trieste'}, 'officialTitle': 'Prolonged Low Doses of Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome', 'orgStudyIdInfo': {'id': 'MP-19 023_2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exposed to Methylprednisolone', 'description': 'Consecutive SARS-CoV-2 positive patients with severe acute respiratory syndrome treated with methylprednisolone (MP) at low prolonged dose, fulfilling inclusion and exclusion criteria.', 'interventionNames': ['Drug: Methylprednisolone', 'Other: standard care']}, {'label': 'Non-exposed to Methylprednisolone', 'description': 'Concurrent patients fulfilling the same inclusion and exclusion criteria, never treated with steroids.', 'interventionNames': ['Other: standard care']}], 'interventions': [{'name': 'Methylprednisolone', 'type': 'DRUG', 'description': 'Usual standard of care plus Methylprednisolone (MP) 80 mg/kg IV bolus, followed by MP infusion of 80 mg/day in 240 mL normal saline at 10 mL/h. The infusion is continued for at least eight days and until achieving either a PaO2:FiO2 \\> 350 mmHg or a CRP \\< 20 mg/L. Treatment is then switched to oral administration of Methylprednisolone 16 mg or 20 mg IV twice daily until CRP returns to \\< 20% of normal range and/or PaO2:FiO2 \\> 400 or SatHbO2 ≥ 95%. The decision to apply the protocol to Covid-19 is left to the discretion of the treating team for each individual patient.', 'armGroupLabels': ['Exposed to Methylprednisolone']}, {'name': 'standard care', 'type': 'OTHER', 'description': 'usual standard of care:\n\n* oxygen therapy (regular or high-flow) and monitoring\n* empiric antibiotic therapy\n* mechanical ventilation (invasive or noninvasive)\n* ECMO when needed and available\n* pronation when possible\n* other treatment which can be used are: antivirals, chloroquine, vitamins', 'armGroupLabels': ['Exposed to Methylprednisolone', 'Non-exposed to Methylprednisolone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34149', 'city': 'Trieste', 'state': 'TS', 'country': 'Italy', 'facility': 'Marco Confalonieri', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}], 'overallOfficials': [{'name': 'Marco Confalonieri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Trieste'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Anonymised data will be available only to data manager who can visualise clinical chart anytime when is needed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Trieste', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Pulmonology and Critical care Dept.', 'investigatorFullName': 'marco confalonieri', 'investigatorAffiliation': 'University of Trieste'}}}}